• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for December 21, 2011

 

December 21, 2011                                                                                                11-51
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
1) Clover sprouts packaged in following sizes: 4.0 oz, 5.0 oz, 1 lb bag, and 2 lb plastic tray. Labeled in part: "Sprouters NORTHWEST, INC. ***CLOVER SPROUTS***KEEP REFRIGERATED***INGREDIENTS: CLOVER SPROUTS***". UPC codes: "8 1509800201 6", "0 7956612362 1", "0 3338370235 3", AND "079566123515". Recall # F-0391-2012;
 
2) Onion sprouts packaged in following sizes: 4.0 oz clamshell labeled in part: "Sprouters NORTHWEST, INC. ***ONION SPROUTS a blend of clover and onion sprouts***KEEP REFRIGERATED***INGREDIENTS: CLOVER AND ONION SPROUTS***". UPC codes: "8 1509800205 4". Recall # F-0392-2012;
 
3) Clover Onion sprouts packaged 5 oz plastic cup labeled in part: "***Sprouters NORTHWEST, INC. ***CLOVER ONION ***KEEP REFRIGERATED***INGREDIENTS: CLOVER AND ONION SPROUTS***". UPC codes: "0 7956612361 4". Recall # F-0393-2012;
 
4) Deli sprouts packaged in 4.0 oz and 5.0 oz units labeled in part: "***Sprouters NORTHWEST, INC.***DELI SPROUTS***KEEP REFRIGERATED***INGREDIENTS: CLOVER, FENUGREEK, LENTILS, RADISH***". UPC codes: "8 7956612305 4" AND "033383702674". Recall # F-0394-2012;
 
5) Broccoli sprouts packaged in 4.0 oz clamshell units labeled in part: "***BROCCO SPROUTS***broccoli & clover sprouts***Sprouters NORTHWEST, INC. ***KEEP REFRIGERATED***INGREDIENTS: BROCCOLI AND CLOVER SPROUTS***".
UPC codes: "815098000289". Recall # F-0395-2012;
CODE
None
RECALLING FIRM/MANUFACTURER
Sprouters Northwest Inc., Kent, WA, by e-mail on January 1, 2011 and by press release on January 3, 2011. Oregon initiated recall is on going.
REASON
Product has potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Clover=12828 lbs; Onion=12 lbs; Clover Onion=367 lbs; Deli=657 lbs; Broccoli=285 lbs; Spicy= 719 lbs
DISTRIBUTION
AK, ID, OR, WA
___________________________________
PRODUCT
GFS Sugar (Azucar), Net Wt. 20 oz (1 lb 4 oz). Recall # F-0396-2012
CODE
Code: G293B (On bottom of Canister)
RECALLING FIRM/MANUFACTURER
Diamond Crystal Brands, Inc., Savannah, GA, by press release on November 21, 2011. Firm initiated recall is ongoing.
REASON
Dairy creamer was inadvertently placed into containers labeled sugar.
VOLUME OF PRODUCT IN COMMERCE
788 cases 24/12 oz units per case
DISTRIBUTION
KY, MI and OH
___________________________________
PRODUCT
MVVC BUFFALO CHICKEN WEDGE Sandwich, 4 oz, plastic wedge. Recall # F-0397-2012
CODE
CLF103 11/21 $1.85
RECALLING FIRM/MANUFACTURER
Lavine Inc & First Vending Corp., Defiance, OH, by letters on November 18, 2011. FDA initiated recall is ongoing.  
REASON
During an FDA inspection, the firm was informed that for their Buffalo Chicken Wedges Sandwich, which contain Swiss cheese, they failed to declare "milk" in its ingredient statement or on its label. They also did not state "cheese" in its ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
223 sandwiches
DISTRIBUTION
IN and OH
___________________________________
PRODUCT
Krasdale Crispy Honey Oats and Flakes --- Naturally & Artificially Flavored Frosted Corn & Wheat Flakes with Rolled Oats & Granola clusters --- Net Wt 14.5 oz (.91 lb) 411g, UPC 0-75130-40405-9. The product is packaged in a cardboard box with inner plastic bag. Recall # F-0407-2012
CODE
BEST IF USED BY SEP 20 12 P04
RECALLING FIRM/MANUFACTURER
Recalling Firm: Krasdale Foods Inc., Bronx, NY, by letter, on December 5, 2011.  
Manufacturer: Gilster-Mary Lee Corp., Mc Bride, MO. Firm initiated recall is ongoing.
REASON
Krasdale brand Crispy Honey Oats and Flakes cereal may contain undeclared almonds.
VOLUME OF PRODUCT IN COMMERCE
828 units
DISTRIBUTION
CT, MA, NJ, NY, PA, RI
___________________________________
PRODUCT
1) TransOcean, Wild Alaska Sockeye Cold Smoked Salmon, Item number 052211. Each case contains 12/4 oz vacuum pouches. UPC 715166302010. The product is labeled in parts: "***TransOCEAN***WILD ALASKA SOCKEYE SMOKED SALMON***INGREDIENTS: SOCKEYE SALMON, SALT, NATURAL SMOKE***Net Wt. 4 oz***12/4 oz*** Attention Retailer***Thaw frozen product under proper refrigeration at 38 F F (3.3D) or below. Thawed product must be code-dated by law before stocking***The thawed product must be labeled with a use by date not to exceed 30 days from the day of thawing***". Recall #F-0408-2012;
 
2) Vital Choice- Cold Smoked Sable Fish Lox Style, Item number 050002. Each case contains 96/4 oz vacuum pouches. No UPC. The product is labeled in parts: "***SMOKED SABLEFISH LOX STYLE***96/4 oz***INGREDIENTS: SABLEFISH, SEA SALT, SUGAR, NATURAL WOOD SMOKE, NOTHING ARTIFICIAL ADDED***VITAL CHOICE SEAFOOD***4oz Net Wt. KEEP FROZEN***Thaw under refrigeration immediately before use***". Recall # F-0409-2012;
 
3) Vital Choice Sockeye Lox is a Wild Alaskan Sockeye Nova Lox. There are 96/4 oz. vacuum pouches per case. The product is labeled in parts: "***WILD ALASKAN SOCKEYE NOVA LOX***96/4 oz NOVA SOCKEYE***INGREDIENTS: WILD ALASKAN SOCKEYE, SEA SALT, NOTHING ARTIFICIAL ADDED***VITAL CHOICE SEAFOOD***4oz Net Wt. KEEP FROZEN***Thaw under refrigeration immediately before use***". Recall # F-0410-2012;
 
4) Portico Prime Nova Style Cold Smoked King Salmon Fillet. Item number 52170. Each case contains 2/2 lb vacuum pouches. UPC 10074865017043. The product is labeled in parts: "***SMOKED KING SALMON FILLET***2/2 lb ave***2/PAK***
INGREDIENTS: Salmon, Salt, Natural Smokes***PORTICO***KEEP FROZEN***Thaw under refrigeration immediately before use ***". Recall #F-0411-2012;
 
5) Portico Bounty- Nova Style Smoked Keta Salmon Fillet; Item 052176. Each case contains 2 packages, 2 lb each. No UPC. Item # on pouch label 1639673. The product is labeled in parts: "***SMOKED KETA SALMON FILLET NOVA STYLE***2/2 lb ave***2/PAK NOVA BOUNTY KETA FILLETS***INGREDIENTS: Salmon, Salt, Sugar, Artificial Color (FD&C Yellow #6 and Red #40), Natural Smokes***PORTICO***KEEP FROZEN***Thaw under refrigeration just prior to use ***". Recall # F-0412-2012;
 
6) RainCoast Brand-Smoked Wild Sockeye Salmon. Item number 052210. Each case contains 20/4 oz. vacuum pouches. UPC 810757007555. The product is labeled in parts: "***RAINCOAST TRADINGS***SMOKED WILD SOCKEYE SALMON***". Recall #F-0413-2012;
 
7) Portico Prime Nova Style Norwegian Center Cut is a sliced, center cut, smoked salmon fillet. Item number 052792. Each case contains 2 Trays, 3 lb each. UPC 1007486550329. The product is labeled in parts: "***SLICED, CENTER CUT, SMOKED NORWEGIAN SALMON FILLET***2/3# PRIME NORWEGIAN TRAYS***INGREDIENTS: Salmon, Salt, Natural Smokes***PORTICO***KEEP FROZEN***Thaw under refrigeration just prior to use ***". Recall #F-0414-2012;
 
8) Nova Style Atlantic Salmon Fillets sold under the following brand names: 1) Mrs Fridays or King & Prince Brand Nova Style Atlantic Salmon Fillet. Item number 052800. Each case contains 2/2 lb vacuum package. No UPC. 2) Portico Prime Nova Style Atlantic Salmon Fillet. Item number 052802. Each case contains 2 vacuum packages, 2 lb each. UPC 00074865503501. The product is labeled in parts: "***PRE-SLICED NOVA ATLANTIC FILLET***2/PAK NOVA ATLANTIC FILLETS***INGREDIENTS: Salmon, Salt, Natural Smokes***KING & PRINCE***KEEP FROZEN***Thaw under refrigeration immediately before use ***". 3) King & Prince or Mrs. Friday's Brand Nova Style Atlantic Salmon 10 /random wts. fillets. Label states Item # 63582, UPC 052805. The product is labeled in parts: "***ATLANTIC NOVA SMOKED SALMON***10 FILLETS***INGREDIENTS: Salmon, Salt, Natural Smoke***KEEP FROZEN***Thaw under refrigeration just prior to use ***" Recall #F-0415-2012;
 
9) Portico Prime Nova Style Norwegian Salmon Fillet. Item 052801. Each case contains 2 vacuum packages, 2 lb each. UPC 00074865503525. The product is labeled in parts: "***SMOKED,SLICED NORWEGIAN SALMON FILLET***2/2.4 LB AVE***2 PAK NOVA PRIME NORWEGIAN FILLETS***INGREDIENTS: Salmon, Salt, Natural Smokes and colored with Astaxanthin***PORTICO***KEEP FROZEN***Thaw under refrigeration just prior to use ***". Recall #F-0416-2012;
 
10) Mrs Friday's Brand Nova Style Atlantic Salmon Trim. Item number 052818. Each case contains 12 vacuum pouches, 1 lb. each. The product is labeled in parts: "***NOVA ATLANTIC SALMON TRIM***Mrs. Friday's***Net Wt. 12 lbs.***INGREDIENTS: Salmon, Salt, Natural Smoke and colored with Astaxathin***KEEP FROZEN***Thaw under refrigeration just prior to use***". Recall #F-0417-2012;
 
11) King & Prince or Mrs. Friday's Brand Nova Style Sockeye Fillets. Item number 052830. Each case contains 2 vacuum packages, 2 lb each. No UPC. The product is labeled in parts: "***SOCKEYE SMOKED SALMON***KING & PRINCE***2/PAK NOVA SOCKEYE FILLETS***INGREDIENTS: Salmon, Sea Salt, and Natural Smoke***KEEP FROZEN***Thaw under refrigeration immediately before use ***". Recall #F-0418-2012;
 
12) King & Prince or Mrs. Friday's Nova Style Sockeye Trim. Item number 52838. Each case contains 12 vacuum packages, 1 lb. each. The product is labeled in parts: "***NOVA SOCKEYE TRIM***SMOKED SALMON***Mrs. Friday's***Net Wt. 12 lbs. ***12/1 lb Pkgs. ***INGREDIENTS: Salmon, Salt, Natural Smoke***KEEP FROZEN***Thaw under refrigeration just prior to use ***". Recall #F-0419-2012;
 
13) Mrs. Friday's Nova Style Chum Trim. Item number 052878. Each case contains 12 vacuum packages, 1 lb. each. The product is labeled in parts: "***NOVA CHUM TRIM***Mrs. Friday's***Net Wt. 12 lbs.***INGREDIENTS: SALMON, SALT, ARTIFICIAL COLOR (FD&c RED #40, YELLOW #6), NATURAL SMOKE ***KEEP FROZEN***Thaw under refrigeration just prior to use ***". Recall #F-0420-2012;
 
14) Mrs. Friday's Nova Style King Salmon Trim. Item number 52898. Each case contains 12 vacuum packages, 1 lb. each. The product is labeled in parts: "***NOVA KING TRIM***Mrs. Fridays***12/1 lb. Pkgs***INGREDIENTS: Salmon, Salt, Natural Smoke and colored with Astaxathin***KEEP FROZEN***Thaw under refrigeration just prior to use ***". Recall # F-0421-2012
 
15) Shirakiku brand Smoked Salmon Sushi Fillet. Item number 56150. The case contains approximately one 5lb. fillets, each fillet packed per vacuum pouch, total 50 lb per box. The product is labeled in parts: "***Shirakiku***SMOKED SALMON FILLETS***50# NET WEIGHT***INGREDIENTS: Salmon, Salt, Sugar, Artificial Color (FD&C Yellow No. 6, Red No. 40) ***KEEP FROZEN***Thaw THAW UNDER REFRIGERATION***". Recall # F-0422-2012;
 
16) 1. Cascade Select Atlantic Salmon Sushi Fillet A. Item number 56160. Each case contains several fillets, approximately 5 lb., and each fillet is vacuum packed, total 50 lb per box; and 2) item number 56164, each case contians several fillets, approximately 5 lb., and each fillet is vaccum packed, total 52 lb. per box. The product is labeled in parts: "***ATLANTIC SALMON SUSHI FILLETS-A***CASCADE Select***Net Wt. 50 lbs.***INGREDIENTS: Salmon, Salt, Sugar, Artificial Color (FD&C Yellow No. 6, Red No. 40) and Natural Smoke***KEEP FROZEN***Thaw under refrigeration just prior to use***". Recall # F-0423-2012;
 
17) Cascade Select Atlantic Salmon Sushi Fillet AA. Item 56161. Each case contains several fillets, approximately 5 lb., and each fillet is vacuum packed, total 50 lb per box. The product is labeled in parts: "***ATLANTIC SALMON SUSHI FILLETS AA***Net Wt. 50 lbs. ***INGREDIENTS: Salmon, Salt, Sugar, Artificial Color (FD&C Yellow No. 6, Red No. 40) and Natural Smoke***KEEP FROZEN***Thaw under refrigeration just prior to use***". Recall # F-0424-2012;
 
18) Atlantic Salmon Sushi Fillet B. Item number 56162. Each case contains several fillets, approximately 5 lb., and each fillet is vacuum packed, total 50 lb per box. The product is labeled in parts: "***ATLANTIC SALMON SUSHI FILLETS-B***Net Wt. 50 lbs. ***INGREDIENTS: Salmon, Salt, Sugar, Artificial Color (FD&C Yellow No. 6, Red No. 40) and Natural Smoke***KEEP FROZEN***Thaw under refrigeration just prior to use***". Recall # F-0425-2012;
 
19) Atlantic Salmon Sushi Fillet sold under the following brand names: 1)Salmon Bay Brand Atlantic Salmon Sushi Fillet. Item 56177. Each case contains several fillets, approximately 5 lb., and each fillet is vacuum packed, total 50 lb per box. The product is labeled in parts: "***ATLANTIC SALMON SUSHI FILLETS***Salmon Bay***Item 56177***Net Wt. 50 lbs.***INGREDIENTS: Salmon, Salt, Sugar, Artificial Color (FD&C Yellow No. 6, Red No. 40)***KEEP FROZEN***Thaw under refrigeration just prior to use***". 2) New Wave Brand Atlantic Salmon Sushi Fillet. Item number 56188. Each case contains several fillets, approximately 5 lb., and each fillet is vacuum packed, total 50 lb per box. The product is labeled in parts: "***ATLANTIC SALMON SUSHI FILLETS***New Wave***item #:56188***Net Wt. 50 lbs***INGREDIENTS: Salmon, Salt, Sugar, Artificial Color (FD&C Yellow No. 6, Red No. 40).***KEEP FROZEN***Thaw under refrigeration just prior to use***". Recall # F-0426-2012;
 
20) Sockeye Teien, item number 56410. Each case contains approximately 5 lbs. fillet per vacuum pouch, total 22 lb per box. The product is labeled in parts: "***TEIEN SOCKEYE FILLETS***Net Wt. 22 lbs***Item#: 56410***INGREDIENTS: Salmon, Salt***KEEP FROZEN***Thaw under refrigeration just prior to use***". Recall # F-0427-2012
CODE
1) Lot/Date Code: 1280W and 1293W. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 280 or 293 is a Julian Date of production; W is a plant identification. 6-digits after W is an Item number;
 
2) Lot/Date code: 1286W. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 286 is a Julian Date of production; W is a plant identification. 6-digits after W are Item number.
 
3) Lot/Date code: 1286W. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 286 is a Julian Date of production; W is a plant identification. 6-digits after W is an Item number;
 
4) Lot/Date code: 1300W052170. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 300 is a Julian Date of production; W is a plant identification. 6-digits after W is an Item number;
 
5) Lot/Date code: 1300W052176, 1314W052176. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 300 or 314 is a Julian Date of production; W is a plant identification. 6-digits after W is an Item number;
 
6) Lot/Date code: 1313W. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 313 is a Julian Date of production; W is a plant identification;
 
7) Lot/Date code: 1286W052792. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 286 is a Julian Date of production; W is a plant identification. 6-digits after W is an Item number;
 
8) 1) Lot/Date code: 1314W052800. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 314 is a Julian Date of production; W is a plant identification. 6-digits after W is an Item number. 2) Lot/Date code: 1293W052802. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 293 is a Julian Date of production; W is a plant identification. 052802 is an Item number. 3) Lot/Date code: 1285W052805 and 1291W052805. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 285 or 291 is a Julian Date of production; W is a plant identification. 052802 is an Item number;
 
9) Lot/Date code: 1286W052801; 1293W052801; 1300W052801. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 286, 293, or 300 is a Julian Date of production; W is a plant identification. 6-digits after W is an Item number;
 
10) Lot/Date code: 1284W; 1285W; 1291W; 1294W; 1299w. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 284, 285, 291, 294, 299 is a Julian Date of production; W is a plant identification;
 
11) Lot/Date code: 128542;
 
12) Lot/Date code: 1280W and 1293W. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 280 or 293 is a Julian Date of production; W is a plant identification;
 
13) Lot/Date code: 1298W. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 280 or 293 is a Julian Date of production; W is a plant identification;
 
14) Lot/Date code: 1299W. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 299 is a Julian Date of production; W is plant identification;
 
15) Lot/Date code: 1284W, 1285W, 1286W, 1291W, 1292W, 1293W, 1299W, 1306W, 1313W, 1314W. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 284, 285, 286, 291, 292, 293, 299, 306, 313, or 314 is a Julian Date of production; W is plant identification;
 
16) 1) Lot/Date code: 1283W, 1290W, 1297W, 1299W, 1303W, 1300W, 1311W, 1312W. 2) Lot/Date code: 1303W. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 283, 290, 297, 299, 300, 303, 311, or 312 is a Julian Date of production; W is plant identification.
 
17) Lot/Date code: 1279W, 1283W, 1285W, 1290W, 1291W, 1297W, 1303W, 1306W, 1307W, 1311W, 1312W, 1313W. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 279, 283, 285, 290, 291, 297, 303, 306, 307, 311, 312 or 313 is a Julian Date of production; W is plant identification;
 
18) Lot/Date code: 1283W, 1281W, 1286W, 1290W, 1291W, 1292W, 1293W, 1297W, 1299W. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 283, 281, 286, 290, 291, 292, 293, 297, or 299 is a Julian Date of production; W is plant identification;
 
19) 1) Lot/Date code: 1283W, 1285W, 1290W, 1293W, 1297W, 1300W, 1303W, 1306W, 1311W, 1312W. 2) Lot/Date code: 1283W Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 283, 285, 290, 293, 297, 300, 303, 306, 311, or 312 is a Julian Date of production; W is a plant identification;
 
20) Lot/Date code: 1287W, 1313W. Date Codes interpretation: All products listed above are marked with a production date code in the following format: First digit (1) signifies production year 2011; 287 or 313 is a Julian Date of production; W is plant identification.
RECALLING FIRM/MANUFACTURER
King & Prince Seafood Corp., Bellingham, WA, by letter on November 22, 2011 and by press release on November 23, 2011. FDA initiated recall is ongoing.
REASON
Salmon Sushi Fillet is recalled because it has the potential to be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
139,900 lbs
DISTRIBUTION
CA, FL, ID, IL, KS, MA, OH, VA, WA and Canada
___________________________________
PRODUCT
Natures Harvest Grape Tomatoes packaged in 5 pound bulk boxes, 1 pint clamshells (packed 12/case), and 1 pint clamshells (packed 6/case). Internal Repack numbers: a) 5 lb. bulk - X0146515, b) 1 pint clamshell (12/case) - X0146555, and c) 1 pint clamshell (6/case) - X0146441. Recall # F-0430-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Combs Produce, LP, Dallas, TX, by e-mail on November 25, 2011. Firm initiated recall is ongoing.
REASON
The tomatoes have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
a) X0146515-20 cases; b) X0146555-21 cases; c) X0146441-360 cases
DISTRIBUTION
OK, TX
___________________________________
PRODUCT
Product is labeled in part: "***BADIA***Pine Nuts (Pinones). Net Wt. 1 oz (28g) packaged in plastic bags and Net Wt. 2 oz (56.7 g) in polyethylene bottles. This member of the nut family, considered an aphrodisiac throughout the Mediterranean and the Middle East is actually a pine seed. Fry until golden in a bit of butter to add a delightfully nutty flavor to meats, rice, salads, pasta dishes and vegetables.***Packed in U.S.A.***0 33844 00068 4***". UPC 033844 00733 for product packaged in pet bottles. UPC 033844 00068 for product packaged in plastic bags. Recall # F-0431-2012
CODE
Lot 84666 - 1 oz. (28 g) plastic recloseable bags. Lot 83184 and 85442 - 2 oz. (56.7 g) plastic bottle.
RECALLING FIRM/MANUFACTURER
Badia Spices, Inc., Miami, FL, by press release on November 4, 2011 and by emails on November 7, 2011. Firm initiated recall is ongoing.
REASON
Product have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,382 cases
DISTRIBUTION
FL, NY, PA, MD, NJ, and West Indies, Nicaragua, Antilies, Dominican Republic, Venezuela, Namibia, Virgin Islands, and Saint Martin
___________________________________
PRODUCT
1) RBC Life Sciences Spirulina Whole Food Bar with Oats & Agave; 1.34 oz Food Bar in a paper carton that is 12 bars per carton. Recall # F-0432-2012;
 
2) RBC Life Sciences Spirulina Whole Food Bar with Oats & Cocoa; 1.34 oz Food Bar in a paper carton that is 12 bars per carton. Recall # F-0433-2012
CODE
1) Lot # 1100410;
2) Lot # 2100410
RECALLING FIRM/MANUFACTURER
Recalling Firm: RBC Life Sciences, Inc., Irving, TX, by visit on May 3, 2011.
Manufacturer: Living Ecology, Inc., Corona, CA. Firm initiated recall is ongoing.  
REASON
Product recalled due to undeclared peanut protein.
VOLUME OF PRODUCT IN COMMERCE
Spirulina Oats & Agave - 6,108 units / Spirulina Oats & Cocoa - 6,278 units
DISTRIBUTION
Canada
___________________________________
PRODUCT
See's Candies, Almond Clusters Roasted Almonds covered in Milk Chocolate; Net Wt. 8 oz (227g). Recall # F-0434-2012
CODE
Code SF 088/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: See's Candies Inc., South San Francisco, CA, by press release and via a Special Bulletin on December 7, 2011.
Manufacturer: See's Candies, Inc., Daly City, CA. Firm initiated recall is ongoing.
REASON
Some 8 oz boxes of Almond Clusters may have been packed with some peanut clusters mixed in with the almond cluster.
VOLUME OF PRODUCT IN COMMERCE
3,600 boxes
DISTRIBUTION
AS, CA, CO, HI, IN, KS, MD, MI, NC, NV, NY, ME, OK, OR, VA, WA, FL, GA, TN, TX, MS and LA
___________________________________
PRODUCT
Brand: Yamaya USA, Inc. Product: Masago Cappelin Roe Item Code: 67980, Net Wt.4.4 lbs (4 pk/case), 6x4x15 plastic bag; Item Code: 10612, Net Wt 2.2 lbs (4 pk/case), 6x8 3/8 x 2 1/4 hard plastic container; Item Code: 09867, Net Wt. 2.0 lbs (4 pk/case), 6x8 3/8 x 2 1/4 hard plastic container. Recall #F-0438-2012
CODE
Lot No: 2591, 2781, 2791
RECALLING FIRM/MANUFACTURER
Yamaya USA Inc., Torrance, CA, by letter and press release on October 21, 2011. FDA initiated recall is ongoing.
REASON
Yamaya USA, Inc. is voluntarily recalling Yamaya Brand Masago (capelin roe) because it has the potential to be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
315 cases
DISTRIBUTION
Nationwide and Mexico
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
1) Lake Champlain PUMPKINS -CARAMEL- DARK BAG- 5 oz cello bag Stock Code: 1F312-000011-1 UPC Code: 76993385372. Recall # F-0257-2012;
 
2) Lake Champlain PUMPKINS AND LEAVES BAG-9 oz. cello bag Stock Code: 1F312-000012-1 UPC: 76993385373. Recall # F-0258-2012;  
 
3) Lake Champlain PUMPKIN BALLOTIN, box 1.25 lbs (sold in LCC stores only) Stock Code: 1Q312-001006-1 UPC: 76993385446. Recall # F-0259-2012;
 
4) Lake Champlain JOLLY ST. NICK ORNAMENT-MILK 1.0 oz box, cello bag Stock Code: 1X312-001022-1 UPC: 76993385365. Recall # F-0260-2012;
 
5) Lake Champlain JOLLY ST. NICK -MILK 1.0 oz cello bag Stock Code: 1X312-001024-1 UPC: 76993385435. Recall # F-0261-2012
CODE
1) Lot Numbers: 11221, 11223, 11243, 11250, 11264, 11271, 11284, 11291;
2) Lot Numbers: 11223, 11224, 11243, 11271, 11291;
3) Lot Numbers: 11223, 11224, 11243, 11271, 11291;
4) Lot Numbers: 11251, 11262, 11272, 11287;
5) Lot Numbers: 11255, 11258
RECALLING FIRM/MANUFACTURER
Lake Champlain Chocolates, Burlington, VT, by telephone, letters, e-mail, and web site on October 19, 2011. Firm initiated recall is ongoing.
REASON
Foreign object in candy.
VOLUME OF PRODUCT IN COMMERCE
16,113 each
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Simplythick Instant Food Thickener, nectar, thickening gel packaged in 15g (0.5 oz.) laminated foil packets, packaged in 200-packet boxes (Product #01001), 80-packet boxes (Product #01005), and Starter Kits containing 10/15g-packets and 1/120g bulk serving packet (Product #01007). The product is also packaged in 120g (4.2 oz.) laminated foil bulk serving packets, packaged in 80-packet cases (Product #01004) and 15-packet cases (Product #01006). Recall # F-0386-2012;
 
2) Simplythick Instant Food Thickener, honey, thickening gel packaged in 30g (1.1 oz.) laminated foil packets, packaged in 100-packet boxes (Product #02001), 50-packet boxes (Product #02005), and Starter Kits containing 7/30g-packets and 1/240g bulk serving packet (Product #02007). The product is also packaged in 240g (8.5 oz.) laminated foil bulk serving packets, packaged in 40-packet cases (Product #02004) and 10-packet cases (Product #02006). Recall # F-0387-2012
CODE
Date codes between 062610 (June 26, 2010) and 062612 (June 26, 2012) AND contains the letter code "TP"
RECALLING FIRM/MANUFACTURER
Recalling Firm: Simply Thick, LLC, Saint Louis, MO, by press release on June 4, 2011, and by e-mail, fax or letter dated June 27, 2011.
Manufacturer: Thermo Pac LLC, Stone Mountain, GA. FDA initiated recall is ongoing.
REASON
The process used to manufacture the products did not have an adequate pathogen kill step.
VOLUME OF PRODUCT IN COMMERCE
27,904,290/15g packets & 986,560/120g packets; and 18,498,666/30g packets and 1,083,130/240g packets/240g packets
DISTRIBUTION
Nationwide and Puerto Rico, Canada, Guatemala, Ecuador, Panama, Barbados, Cayman Islands, and Italy
___________________________________
PRODUCT
1) Frozen Peach Strudel Log is sold raw, frozen at farmer market. It is individually packaged in a clear plastic bag with a baking tray, baking instruction, and labeled. The product is labeled in parts: "***Wheat flour (wheat flour, malted barley flour, niacin, iron, thiamine mononitrate, riboflavin, folic acid), filtered water, butter (pasteurized cream milk), peaches, sugar, almonds, modified food starch (corn), salt***Contains wheat, milk and almonds***". Recall # F-0398-2012;
 
2) Frozen Blueberry Strudel Log is sold raw, frozen at farmer market. It is individually packaged in a clear plastic bag with a baking tray, baking instruction, and labeled. There is no UPC code. The old label was not provided. Recall # F-0402-2012;
 
3) Frozen Cherry Strudel Log is sold raw, frozen at farmer market. It is individually packaged in a clear plastic bag with a baking tray, baking instruction, and labeled. There is no UPC code. The old label was not provided. Recall # F-0403-2012;
 
4) Frozen Apricot Strudel Log is sold raw, frozen at farmer market. It is individually packaged in a clear plastic bag with a baking tray, baking instruction, and labeled. There is no UPC code. The old label was not provided. Recall F-0404-2012;
 
5) Frozen Pear Strudel Log is sold raw, frozen at farmer market. It is individually packaged in a clear plastic bag with a baking tray, baking instruction, and labeled. There is no UPC code. The old label was not provided. Recall # F-0405-2012
CODE
No codes
RECALLING FIRM/MANUFACTURER
Kompier's Windmill Bakery, Grants Pass, OR, by letter on November 3, 2011. FDA initiated recall is ongoing.
REASON
Margarine (Soybean Oil, Non-fat dry milk solids, Soy Lecithin) and/or Soy Shortening were not declared on the ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
OR
___________________________________
PRODUCT
Nature's Own Butterbread loaf is labeled in part: "***Nature's Own Butterbread***No Artificial Preservatives, Color or Flavors***No High Fructose Corn Syrup***ENRICHED BREAD***net wt. 20 oz. (1 lb. 4 oz.) (567g)***Nutrition Facts***Serving Size 1 Slice (25g / .9 oz)***Servings Per Container 22***Amount Per Serving***Calories 60*** Grains for Life***0 72250 04919 1.***" Recall # F-0406-2012
CODE
Best By Date: 12/7/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Flowers Food Speciality Group, Tucker, GA, by press release on December 1, 2011.   
Manufacturer: Flowers Baking Company of Jacksonville, LLC, Jacksonville, FL. Firm initiated recall is ongoing.
REASON
Product may contain small flakes of aluminum.
VOLUME OF PRODUCT IN COMMERCE
19,648 loaves
DISTRIBUTION
FL, GA
___________________________________
PRODUCT
Cathay brand Egg rolls Vegetable and Shrimp Net Wt, 15 oz, Pre Cooked Heat and Serve Keep Frozen UPC #42203 39115. Recall # F-0429-2012
CODE
Codes: 2011387, 2011388, 2011389
RECALLING FIRM/MANUFACTURER
Cathay Foods, Inc., Boston, MA, by letter dated December 5, 2011. FDA initiated recall is ongoing.
REASON
The product contains undeclared colors - FD&C Yellow # 5 and FD&C Yellow # 6.
VOLUME OF PRODUCT IN COMMERCE
1,092 package
DISTRIBUTION
NH, MA
___________________________________
PRODUCT
Las Palmas Green Chile Enchilada Sauce Net Wt. 19 oz; UPC 041501110201, Serving Size 1/4 cup (60 g).  Recall # F-0435-2012
CODE
Best By Dates of December 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: B&G Foods, Inc., Parsippany, NJ, by letters dated July 8, 2011.
Manufacturer: Border Foods, Inc., Deming, NM. Firm initiated recall is ongoing.
REASON
Las Palmas Green Enchilada Sauce contains wheat which is not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
44000 cases (12 units in each)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Aristolochic serpentaria is packaged in amber Boston round glass bottles 30 ml, 120 ml, 240 ml, 480 ml and 960 ml increments and also based on the amount of product ordered. The product is labeled: "***Heron Botanicals***Aristolochia serpentaria***Tincture of dried Virginia snakeroot rhizome, 1:10***Ingredients: water, ethanol (extract at 40%), vegetable glycerin, Aristolochia serpentaria***Batch # 05029520.1***120 ml (4 oz)***Mfg. Date Feb 2005***". Recall # F-0436-2012
CODE
No expiration date. This code ARIS-SER-TXR-05029520.1 may be observed on a label. The code is interpreted as: ARIS-Genus; SER-Species; T-tinture; X-only one part of this plant is processed by the firm; R-restricted status; 05-2005 is the year of manufacture; 02-February is the month of manufacture; 9520-relics of their firm's old product ID system, no longer used on batches produced from 2010 forward. .1-batch # 1 was made.
RECALLING FIRM/MANUFACTURER
Heron Botanicals Inc., Poulsbo, WA, by letters and e-mails on October 22, 2011.  FDA initiated recall is ongoing.
REASON
The product contains aristolochic acid.
VOLUME OF PRODUCT IN COMMERCE
1,879 mL
DISTRIBUTION
AL, AZ, CA, CT, KS, and WA
___________________________________
PRODUCT
The biscotti is packaged in an eight (8) ounce box and labeled in part, "be-bop biscotti ALMOND HAND CRAFTED BISCOTTI NET WT 8 OZ (227 g) ***INGREDIENTS: Enriched flour***sugar, eggs, almonds, butter (cream, salt), pure almond extract, baking powder***". Recall # F-0437-2012
CODE
BEST USED BY: 6/10/12
RECALLING FIRM/MANUFACTURER
Di Lusso-Be Bop, LLC dba Be-Bop Biscotti, Bend, OR, by telephone on November 30, 2011. FDA initiated recall is ongoing.
REASON
The firm declares butter (cream, salt) on the product label, but does not specifically declare milk.
VOLUME OF PRODUCT IN COMMERCE
18 - 8 ounce boxes
DISTRIBUTION
WA, TN and NY
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
1) Hilmar Cheese Company 40 pound block cheeses packaged in polyethylene bags and corrugated boxes. Labeled as: Monterey Jack Cheese Ingredients: Pasteurized Milk, Cheese Cultures, Salt, and Enzymes NET WT. 40.01 LB 18.6 KG FACT. NO. 48-0206. Recall # F-0242-2012;
 
2) Hilmar Cheese Company 40 pound block cheeses packaged in polyethylene bags and corrugated boxes. Labeled as: Milled Cheddar Cheese Ingredients: Pasteurized Milk, Cheese Cultures, Salt, and Annatto NET WT. 40.01 LB 18.6 KG FACT. NO. 48-0206. Recall # F-0243-2012;
 
3) Hilmar Cheese Company 40 pound block cheeses packaged in polyethylene bags and corrugated boxes. Labeled as: Cheddar Cheese Ingredients: Pasteurized Milk, Cheese Cultures, Salt, Enzymes and Annatto NET WT. 40.01 LB 18.6 KG FACT. NO. 48-0206. Recall # F-0244-2012;
 
4) Hilmar Cheese Company 40 pound block cheeses packaged in polyethylene bags and corrugated boxes. Labeled as: White Cheddar Cheese Ingredients: Pasteurized Milk, Cheese Cultures, Salt, and Enzymes NET WT. 40.01 LB 18.6 KG FACT. NO. 48-0206. Recall # F-0245-2012;
 
5) Hilmar Cheese Company 40 pound block cheeses packaged in polyethylene bags and corrugated boxes. Labeled as: Colby Cheese Ingredients: Pasteurized Milk, Cheese Cultures, Salt, Enzymes, and Annatto NET WT. 41.01 LB 18.6 KG FACT. NO. 48-0206. Recall # F-0246-2012;
 
6) Hilmar Cheese Company 40 pound block cheeses packaged in polyethylene bags and corrugated boxes. Labeled as: Colby Jack Cheese Ingredients: Pasteurized Milk, Cheese Cultures, Salt, Enzymes, and Annatto NET WT. 41.01 LB 18.6 KG FACT. NO. 48-0206. Recall # F-0247-2012;
 
7) Hilmar Cheese Company 40 pound block cheeses packaged in polyethylene bags and corrugated boxes. Labeled as: Reduced Fat Monterey Jack Cheese Ingredients: Pasteurized Part Skim Milk, Cheese Cultures, Salt, Enzymes, and Vitamin A Palmitate NET WT. 41.01 LB 18.6 KG FACT. NO. 48-0206. Recall # F-0248-2012;
 
8) Hilmar Cheese Company 40 pound block cheeses packaged in polyethylene bags and corrugated boxes. Labeled as: Asadero Cheese Ingredients: Pasteurized Milk, Cheese Cultures, Salt, and Enzymes NET WT. 41.01 LB 18.6 KG FACT. NO. 48-0206. Recall # F-0249-2012;
 
9) Hilmar Cheese Company 40 pound block cheeses packaged in polyethylene bags and corrugated boxes. Labeled as: Queso Quesadilla Cheese Ingredients: Pasteurized Milk, Cheese Cultures, Salt, and Enzymes NET WT. 41.01 LB 18.6 KG FACT. NO. 48-0206. Recall # F-0250-2012;
 
10) Hilmar Cheese Company 40 pound block cheeses packaged in polyethylene bags and corrugated boxes. Labeled as: Ungrd Colored Cheese BBL Ingredients: Pasteurized Milk, Cheese Cultures, Salt, Enzymes, Annatto and Natamycin NET WT. 41.01 LB 18.6 KG FACT. NO. 48-0206. Recall # F-0251-2012;
 
11) Hilmar Cheese Company 40 pound block cheeses packaged in polyethylene bags and corrugated boxes. Labeled as: Ungrd M. Jack w/Peppers Cheese BBL Ingredients: Pasteurized Milk, Jalapeno Peppers (Jalapeño Peppers, Salt, Acetic Acid, and Calcium Chloride), Cheese Cultures, Salt, Acetic Acid, Enzymes, and Natamycin NET WT. 41.01 LB 18.6 KG FACT. NO. 48-0206. Recall # F-0252-2012;
 
12) Hilmar Cheese Company 40 pound block cheeses packaged in polyethylene bags and corrugated boxes. Labeled as: Monterey Jack Cheese w/Jalapeno Peppers Ingredients: Pasteurized Milk, Jalapeno Peppers (Jalapeno Peppers, Salt, Acetic Acid, and Calcium Chloride), Cheese Cultures, Salt, and Enzymes NET WT. 41.01 LB 18.6 KG FACT. NO. 48-0206. Recall # F-0253-2012;
 
13) Product 13 - 59022 13) Hilmar Cheese Company 40 pound block cheeses packaged in polyethylene bags and corrugated boxes. Labeled as: Ungrd White Cheese BBL Ingredients: Pasteurized Milk, Cheese Cultures, Salt, Enzymes, and Natamycin NET WT. 41.01 LB 18.6 KG FACT. NO. 48-0206. Recall # F-0254-2012;
 
14) Hilmar Cheese Company 40 pound block cheeses packaged in polyethylene bags and corrugated boxes. Labeled as: Colored Fines Ingredients: Pasteurized Milk, Cheese Cultures, Salt, Annatto, and Enzymes TARE 1.25 LB 0.6 KG NET 402.35 LB 182.5 KG FACT. NO. 48-0206. Recall # F-0255-2012;
 
15) Hilmar Cheese Company 40 pound block cheeses packaged in polyethylene bags and corrugated boxes. Labeled as: White Cheese Fines Ingredients: Pasteurized Milk, Cheese Cultures, Salt, and Enzymes (May Contain Vitamin A Palpitate) TARE 1.25 LB 0.6 KG NET 402.35 LB 182.5 KG FACT. NO. 48-0206 Recall # F-0256-2012
CODE
Produced from 04-19-11 through 05-18-11 in vats 1-5
RECALLING FIRM/MANUFACTURER
Hilmar Cheese Company, Inc., Dalhart, TX, by letters on May 27 and May 31, 2011 and June 2, 2011. Firm initiated recall is ongoing.
REASON
Plastic extraneous material has been discovered in the recalled 40 lbs block cheeses.
VOLUME OF PRODUCT IN COMMERCE
14,926,268.66 pounds
DISTRIBUTION
CA, IL, IN, MN, MO, NY, OH, TX, and WI
___________________________________
PRODUCT
1) Frozen Apple Strudel Log is sold raw, frozen at farmer market. It is individually packaged in a clear plastic bag with a baking tray, baking instruction, and labeled. There is no UPC code. The product is labeled in parts: "***Wheat flour (wheat flour, malted barley flour, niacin, iron, thiamine mononitrate, riboflavin, folic acid), filtered water, butter (pasteurized cream milk), apples (apples, salt, erythorbic or ascorbic acid), sugar, shortening (interesterified soybean oil, hydrogenated soybean oil), almonds, modified food starch (corn), salt***Contains wheat, milk, soybean and almonds***”. Recall # F-0399-2012;
 
2) Frozen Raspberry Strudel Log is sold raw, frozen at farmer market. It is individually packaged in a clear plastic bag with a baking tray, baking instruction, and labeled. There is no UPC code. The product is labeled in parts: "***Wheat flour (wheat flour, malted barley flour, niacin, iron, thiamine mononitrate, riboflavin, folic acid), filtered water, butter (pasteurized cream milk), raspberries, sugar, shortening (interesterified soybean oil, hydrogenated soybean oil), almonds, modified food starch (corn), salt***Contains wheat, milk and almonds***". Recall # F-0400-2012;
 
3) Frozen Blackberry Strudel Log is sold raw, frozen at farmer market. It is individually packaged in a clear plastic bag with a baking tray, baking instruction, and labeled. There is no UPC code. The product is labeled in parts: "***Wheat flour (wheat flour, malted barley flour, niacin, iron, thiamine mononitrate, riboflavin, folic acid), filtered water, butter (pasteurized cream milk), blackberries, sugar, shortening (interesterified soybean oil, hydrogenated soybean oil), almonds, modified food starch (corn), salt***Contains wheat, milk, soybean and almonds***". Recall # F-0401-2012;
CODE
No codes
RECALLING FIRM/MANUFACTURER
Kompier's Windmill Bakery, Grants Pass, OR, by letter on November 3, 2011. FDA initiated recall is ongoing.
REASON
Margarine (Soybean Oil, Non-fat dry milk solids, Soy Lecithin) and/or Soy Shortening were not declared on the ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
OR
___________________________________
PRODUCT
Jon Donaire Ice Cream Layer Cake, Deliciously moist white cake with rich, creamy strawberries & cream ice cream. Keep Frozen Packaged in 4 lb 13 oz container. Product code (PC) 04776 UPC: 049800047761. Recall # F-0428-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Rich Products Corp., Buffalo, NY, by letter on March 4, 2011. Firm initiated recall is ongoing.
REASON
Ice Cream Layer Cake (Strawberries & Cream) is being recalled because the strawberry filling contains undeclared food color additive FD&C Red 40.
VOLUME OF PRODUCT IN COMMERCE
2,632 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Red Star Kombucha Tea, 12 fl oz. Recall # F-0439-2012
CODE
No code/all product shipped before 11/23/2011
RECALLING FIRM/MANUFACTURER
Red Star Specialty Foods, LLC, Pittsburgh, PA, by visit beginning November 30, 2011. FDA initiated recall is ongoing.
REASON
The product contains alcohol however alcohol is not listed/displayed on the label.
VOLUME OF PRODUCT IN COMMERCE
56 bottles
DISTRIBUTION
PA
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report17, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS
­­
None this week.
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
1) Today's Health, Infants', Gas Relief, Liquid Drops, 1 fl oz (30 mL), UPC 843072003919, NDC 62982-520-01;
2) Premier Value, Infants' Drops, Gas Relief, Dye Free Drops, Non-Staining, Safe Enough to Use, at Every Feeding, 1 fl oz, (30 mL), UPC 840986015083;
3) Kroger, Infants', Gas Relief , Drops, Simethicone 20 mg/Anti-Gas, Dye Free Drops, Non-Staining, Our Pharmacists Recommend, 1 fl oz (30 mL), 100 Doses, UPC 011110383471;
4) CVS Infants' Gas Relief, Non-Staining Formula, Simethicone/Antigas, No Alcohol, No Saccharin, No Artificial Flavor, 1 fl oz (300 mL), 100 Doses, Liquid Drops (1 oz.) bottle, OTC only, UPC 050428511381;
5) Equate Infants' Gas Relief, Simethicone 20 mg, Drops, Safe Enough to Use, at Every Feeding, Dye Free, Non-staining formula, No alcohol or saccharin, No artificial flavors, No artificial colors, Use as directed, 1 fl oz (30 mL), 100 Doses, UPC 681131769433;
6) Duane Reade Infants' Gas Relief, 1 fl oz. (30 mL), UPC 6-39194-04493-6;
7) Shopko Infants' Gas Relief, 1 oz (30 mL), UPC 4-00131-35561-9;  
Recall # D-873-2012
CODE
1) Lot #: a) 8014, Exp. 11/12;
2) Lot #: a) 7837, Exp. 11/12;
3) Lot #: a) 8014, Exp. 11/12;
4) Lot #: a) 7841, Exp. 11/12.
5) Lot #: a) 7577, Exp. 11/12; b) 7837, Exp. 11/12; c) 7838, Exp. 11/12; d) 7839, Exp. 11/12 ; e) 7575, Exp. 11/12; f) 7576, Exp. 11/12; g) 7840, Exp. 11/12; h) 8015, Exp. 11/12; i) 8065, Exp. 12/12; j) 8066, Exp. 12/12; k) 8068, Exp. 12/12; and l) 8069, Exp. 12/12;
6) Lot #: a) 9221, Exp. 03/13;
7)  Lot #: a) 9263, Exp. 03/13
RECALLING FIRM/MANUFACTURER
Raritan Pharmaceuticals, Inc., East Brunswick, NJ, by letter on August 3, 2011 and September 16, 2011. Firm initiated recall is ongoing.
REASON
Microbial Contamination of Non-Sterile Product: Various brands of Infant Gas Relief Drops may have microbial contamination with Burkholderia cepacia due to a raw material that was used to manufacture the product.
VOLUME OF PRODUCT IN COMMERCE
165,024 units; 9/16/201: 651312 units (expansion)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Trelstar (triptorelin pamoate) for injectable suspension with Mixject, 3.75 mg, One Single-Dose Vial plus One Mixject Single-Dose Delivery System and a sterilized convenience kit containing alcohol prep pad, guaze sponge, label for patient's record and an adhesive strip, Rx only, Alcohol Prep pad labeled as Triad Sterile Alcohol Prep Pad, 1-count pad per pouch; NDC for Trelstar 52544-189-76. Recall # D-897-2012
 
2) Trelstar (triptorelin pamoate) for injectable suspension with Mixject, 11.25 mg, One Single-Dose Vial plus One Mixject Single-Dose Delivery System and a sterilized covenience kit containing alcohol prep pad, gauze sponge, label for patient's record and an adhesive strip, Rx only, Alcohol Prep pad labeled as Triad Sterile Alcohol Prep Pad, 1-count pad per pouch; NDC for Trelstar 52544-188-76. Recall # D-898-2012;
 
3) Trelstar (triptorelin pamoate) for injectable suspension with Mixject, 22.5 mg, One Single-Dose Vial plus One Mixject Single-Dose Delivery System and a sterilized convenience kit containing alcohol prep pad, gauze sponge, label for patient's record and an adhesive strip, Rx only, Alcohol Prep pad labeled as Triad Sterile Alcohol Prep Pad, 1-count pad per pouch; NDC for Trelstar 52544-092-76. Recall # D-899-2012
CODE
All lots containing the convenience kit with the recalled component
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watson Pharmaceuticals Inc., Corona, CA, by press release and letter on February 4, 2011.  
Manufacturer: Watson Pharma, Inc., Morristown, NJ. Firm initiated recall is ongoing.
REASON
Microbial Contamination of Non-Sterile Products: The convenience kit contained within the Trelstar (triptorelin pamoate) for injectable suspension products is being recalled because it contains alcohol prep pads manufactured by Triad Group that was previously recalled due to the potential contamination of the pads with the bacteria Bacillus cereus.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Indiana DOT First Aid Kit, CSM #G201068, Poly White Box labeled Indiana Department of Transportation with the DOT logo, containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-900-2012;
 
2) Indiana DOT First Aid Kit, CSM #G201069, Poly White Box labeled Indiana Department of Transportation with the DOT logo, containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-901-2012;
 
3) State of Ohio First Aid Kit, CSM #G202000, Metal Box labeled State of Ohio Department of Transportation with State of Ohio DOT logo, containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-902-2012;
 
4) Texas Department of Public Safety First Aid Kit, CSM #G208093, kit labeled with Department of Public Safety logo, containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-903-2012;
 
5) State of Ohio DOT Refill First Aid Kit, CSM #GR202000, First Aid Refill kit, containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the refill kit also contains other components not listed in this product description. Recall # D-904-2012;
 
6) Clark Public Utilities First Aid Kit, CSM #K200110, First Aid kit with logo, containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-905-2012;
 
7) City of Peoria Arizona First Aid Kit, CSM #K201011, First Aid kit, containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall D-906-2012;
 
8) Southwest Gas Corporation First Aid Kit, CSM #K201043, First Aid kit with Southwest Gas Corporation logo, containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-907-2012;
 
9) Southwest Gas Corporation First Aid Kit, CSM #K201044, First Aid kit with Southwest Gas Corporation logo, containing 2 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-908-2012;
 
10) Rail America First Aid Kit, CSM #K201050, First Aid kit, containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-909-2012;
 
11) Mechanics First Aid Kit, CSM #K201061, metal First Aid kit, containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-910-2012;
 
12) Construction Safety Products First Aid Kit, CSM #K201073, First Aid kit with logo, containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-911-2012;
 
13) Maricopa County DOT First Aid Kit, CSM #K201114, First Aid kit with Maricopa County logo, containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-912-2012;
 
14) CSE First Aid Kit, CSM #K201137, First Aid kit with CSE logo, containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-913-2012;
 
15) CSE First Aid Kit, CSM #K201138, First Aid kit with CSE logo, containing 2 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-914-2012;
 
16) CSE First Aid Kit, CSM #K201139, First Aid kit with CSE logo, containing 3 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-915-2012;
 
17) Construction Sound Safety First Aid Kit, CSM #K201170, First Aid kit with logo, containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-916-2012;
 
18) Mini First Aid Pouch Kit, CSM #K201197, green nylon bag containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-917-2012;
 
19) Extra Large First Aid Pouch Kit, CSM #K201198, green nylon bag containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-918-2012;
 
20) Mini First Aid Pouch Kit, CSM #K201199, white nylon bag containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-919-2012;
 
21) Mini First Aid Pouch Kit, CSM #K201201, black nylon bag containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-920-2012;
 
22) Extra Large First Aid Pouch Kit, CSM #K201202, black nylon bag containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-921-2012;
 
23) Elite First Aid Kit, CSM #K201252, Poly white kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-922-2012;
 
24) Elite First Aid Kit, CSM #K201254, metal kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-923-2012;
 
25) FAA Airline First Aid Kit, CSM #K201254, metal kit containing 2 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-924-2012;
 
26) FAA Airline First Aid Kit, CSM #K201324, Poly White kit containing 2 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-925-2012;
 
27) UP - Vehicle First Aid Kit, CSM #K201417, First Aid kit with UPRR logo, containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-926-2012;
 
28) Washington Gas First Aid Kit, CSM #K201442, First Aid kit with logo, containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-927-2012;
 
29) Puget Sound Energy First Aid Kit, CSM #K201469, Metal Box labeled Puget Sound First Aid, with PSE logo, Safety, Made In America With Certified Pride; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-928-2012;
 
30) Marek Brothers First Aid Kit, CSM #K201656, First Aid kit with 2 color logo; containing 5 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-929-2012;
 
31) ANSI General Purpose First Aid Kit, CSM #K202015, Poly White kit; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-930-2012;
 
32) ANSI General Purpose First Aid Kit, CSM #K202016, metal kit; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-931-2012;
 
33) ANSI General Purpose First Aid Kit, CSM #K202017, metal kit; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-932-2012; 
 
34) ANSI General Purpose First Aid Kit, CSM #K202018, metal kit; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-933-2012;
 
35) ANSI General Purpose First Aid Kit, CSM #K202019, Poly White kit; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-934-2012; 
 
36) Sound Safety First Aid Kit, CSM #K202023, First Aid kit with logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-935-2012;
 
37) Sound Safety First Aid Kit, CSM #K202024, First Aid kit with logo; containing 2 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-936-2012;
 
38) General Purpose First Aid Kit, CSM #K202025, Poly Clear kit; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-937-2012;
 
39) General Purpose First Aid Kit, CSM #K202040, Poly Clear kit; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-938-2012;
 
40) UP Trauma First Aid Kit, CSM #K202065, Box labeled as Trauma Kit, Flambeau PM 2072, Item # 3804953, Property of Union Pacific, with Union Pacific logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall #
D-939-2012;
 
41) UP Commuter Passenger First Aid Kit, CSM #K202411, Ziplock bag containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-940-2012;
 
42) UPRR First Aid Kit refill, CSM #K202415, Ziplock bag containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the refill kit also contains other components not listed in this product description. Recall # D-941-2012;
 
43) City of Gastonia First Aid Kit, CSM #K202501, containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-942-2012;
 
44) Travel First Aid Kit, CSM #K205023, containing 4 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-943-2012;
 
45) PB Snake Bite Kit, CSM #K205033, plastic box containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-944-2012;
 
46) UB Snake Bite Kit, CSM #K205033, containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-945-2012;
 
47) Safety Award First Aid Kit, CSM #K205040, Poly White Box containing 4 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-946-2012;
 
48) Swan Food First Aid Kit, CSM #K205045, Poly White Box labeled with the Certified Safety Mfg. logo; containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-947-2012;
 
49) ANSI Quality First Aid Kit, CSM #K206000, Metal kit containing 5 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-948-2012;
 
50) ANSI Quality First Aid Kit, CSM #K206001, Poly White kit containing 5 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-949-2012;
 
51) ANSI Quality First Aid Kit, CSM #K206003, Metal kit containing 5 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-950-2012;
 
52) ANSI Quality First Aid Kit, CSM #K206004, Poly White kit containing 5 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-951-2012;
 
53) Quality Bulk First Aid Kit, CSM #K206005, Metal kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-952-2012;
 
54) Quality Bulk First Aid Kit, CSM #K206006, Metal kit containing 2 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-953-2012;
 
55) Pocket First Aid Kit, CSM #K206008, Pocket Kit labeled with the Certified Safety Mfg. logo; containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-954-2012;
 
56) Auto Kit, CSM #K206009, Kit labeled with the Certified Safety Mfg. logo; containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall D-955-2012;
 
57) Personal First Aid Kit, CSM #K206035, containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-956-2012;
 
58) Quality Bulk First Aid Kit, CSM #K206060, Poly White kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-957-2012;
 
59) Quality Bulk First Aid Kit, CSM #K206061, Poly White kit containing 2 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-958-2012;
 
60) Philadelphia Gas Works First Aid Kit, CSM #K206108, kit with logo containing 3 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-959-2012;
 
61) CSX Pocket First Aid Kit, CSM #K206109, kit with logo containing 4 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-960-2012;
 
62) Turtle Top FL DOT First Aid Kit, CSM #K206123, kit with logo containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-961-2012;
 
63) Economy First Aid Kit, CSM #K206125, 3 shelf cabinet containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet a vlso contains other components not listed in this product description. Recall # D-962-2012;
 
64) Standard First Aid Cabinet, CSM #K206130, Swing Out Door 2 shelf cabinet containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-963-2012;
 
65) FDD Standard First Aid Cabinet, CSM #K206134, cabinet containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-964-2012;
 
66) CLS Deluxe 3 Shelf Cabinet, CSM #K206140, 3 Shelf Cabinet labeled a) Control Fire & Safety, Inc., First Aid, CLX, Made In America With Certified Pride; b) Braud Welding & Industrial Supply, First Aid; c) Brigade, Pro-Grade Construction Products Available At, HD Supply, White Cap Construction Supply, First Aid; containing 1 x 25-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", Reorder R233-096, UPC 7 66588 33096 9; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-965-2012;
 
67) FAC Deluxe 4 Shelf Cabinet, CSM #K206152, 4 Shelf Cabinet labeled a) with the Certified Safety Mfg. logo; b) Brigade, Pro-Grade Construction Products Available At, HD Supply, First Aid; c) California Service Tool, FAC-4, First Aid; d) Harold E. Nutter & Son, Inc., Electrical Contractors and Engineers, FAC-4, First Aid; e) Beck Industries Fire & Safety Equipment; f) ORR Safety, America's Safety Net, FAC-4; g) CIC Medical Products, P/N: 85004C, First Aid; h) National Safety Compliance, FAC-4; i) Menorah Medical Center, HCA Midwest Health System, FAC-4; j) UZ Medical, FAC-4; k) WIT Community College, First Aid; l) LifeSavers, Inc., FAC-4; m) OES Equipment, FAC-4; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-966-2012;
 
68) Deluxe 3 Shelf Cabinet, CSM #K206154, 3 Shelf Cabinet containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-967-2012;
 
69) Office First Aid Cabinet, CSM #K206155, cabinet containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-968-2012;
 
70) Office Cabinet, CSM #K206156, 3 Shelf cabinet containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-969-2012;
 
71) FAC Deluxe 5 Shelf Cabinet, CSM #K206162, 5 Shelf Cabinet labeled a) with the Certified Safety Mfg. logo; b) Powerhouse Tool & Supply, Inc., 1-800-866-5833, First Aid; c) National Safety Compliance, FAC-5; d) Menorah Medical Center, HCA Midwest Health System, FAC-5; e) Control Fire & Safety, Inc., FAC-5; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-970-2012;
 
72) CLX Industrial First Aid Cabinet, CSM #K206180, 3 Shelf Cabinet labeled a) with the Certified Safety Mfg. logo; b) Lewis-Goetz and Company, Inc., Belting, Hose and Sealing Solutions Since 1935, CLX; c) complete medical supplies, Reorder #2203, CLX; d) Brigade, Pro-Grade Construction Products Available At, HD Supply, White Cap Construction Supply; 3) Peachtree, HPF-A100; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-971-2012;
 
73) FAC DLX Deluxe w/ BBP 4 Shelf Cabinet, CSM #K206205, 4 Shelf Cabinet labeled a) with the Certified Safety Mfg. logo; b) Brigade, Pro-Grade Construction Products Available At, HD Supply, White Cap Construction Supply; c) ORR Safety, America's Safety Net; d) WIT Community College, First Aid; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-972-2012;
 
74) FAC Deluxe 3 Shelf Cabinet, CSM #K206210, 3 Shelf Cabinet labeled a) with the Certified Safety Mfg. logo; b) Sea Safety & Survival, Inc., FAC-3, First Aid; c) Nat!onal Safety Compliance, FAC-3; c) California Service Tool with CST logo, FAC-3; d) Alsco, FAC-3; e) Alsco, FAC-3; f) Osha4less.com, Keeping you compliant, FAC-3; g) Beck Industries, Fire & Safety Equipment; h) ORR Safety, America's Safety Net, FAC-3; i) JE Dunn Construction, with JE Dunn logo; j) Five Star Safety Equipment, Inc., with Five Star logo; k) Lewis-Goetz and Company, Inc., Belting, Hose and Sealing Solutions Since 1935; l) WIT Community college, First Aid; m) UZ Medical First Aid; n) Brigade, Pro-Grade Construction Products Available At, HD Supply, White Cap Construction Supply, 1 800 White Cap; o) White Cap Construction Supply, Brock Tool & Supply, First Aid; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-973-2012;
 
75) CLX Economy Cabinet, CSM #K206212, 3 Shelf Cabinet labeled a) with the Certified Safety Mfg. logo; b) Osha4less.com, Keeping you compliant, FAC-3; c) ORR Safety, America's Safety Net, CLX; d) WIT Community College, First Aid; e) complete medical supplies, inc., Reorder #2203, CLX; f) Pearlgreen Corporation, The Industrial Supply Group; g) Brigade, Pro-Grade Construction Products Available At, HD Supply, White Cap Construction Supply; h) Peachtree, HPF-A100, First Aid Kit; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-974-2012;
 
76) New Jersey Transit RAIL First Aid Kit, CSM #K208003, kit with logo containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-975-2012;
 
77) Enbridge First Aid Kit, CSM #K208074, kit with logo containing 2 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-976-2012;
 
78) Enbridge First Aid Kit, CSM #K208076, kit with logo containing 2 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-977-2012;
 
79) Frisch 50 First Aid Cabinet; CSM #K208090, 3 Shelf Cabinet labeled with the Certified Safety Mfg. logo; containing 1 x 100-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", Reorder R233-097, UPC 7 66588 33097 6; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-978-2012;
 
80) Embarq First Aid Kit; CSM #K208102, kit labeled with the Certified Safety Mfg. logo; containing 2 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-979-2012;
 
81) Williams Energy First Aid Kit; CSM #K208305, kit with 2 color logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-980-2012;
 
82) Trauma Kit with Orange Co-Polymer Case; CSM #K209061, Trauma Box labeled with the Certified Safety Mfg. logo; containing 1 x 25-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", Reorder R233-096, UPC 7 66588 33096 9; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-981-2012;
 
83) Industrial First Aid Cabinet; CSM #K209080, 5 Shelf Cabinet labeled with the Certified Safety Mfg. logo; containing 1 x 25-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", Reorder R233-096, UPC 7 66588 33096 9; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-982-2012;
 
84) Medicine Cabinet with 4 Shelves and Locking Door; CSM #K209090, Medicine Cabinet labeled with the Certified Safety Mfg. logo; containing 1 x 25-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", Reorder R233-096, UPC 7 66588 33096 9; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-983-2012; 
 
85) Welders Kit; CSM #K209116, Metal kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-984-2012;
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                86) Welders Kit; CSM #K209124, Metal kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-985-2012;
 
87) Shop Kit; CSM #K209150, Poly White kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-986-2012;
 
88) Shop Kit; CSM #K209151, Metal kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-987-2012;
 
89) Shop First Aid Kit; CSM #K209152, Poly White kit containing 2 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-988-2012;
 
90) ANSI Construction Kit; CSM #K209216, Metal kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-989-2012;
 
91) ANSI Construction Kit; CSM #K209224, Metal kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-990-2012;
 
92) ANSI Construction Kit; CSM #K209236, Metal kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-991-2012;
                                  
93) ANSI Construction Kit; CSM #K209242, Poly White kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-992-2012;
 
94) ANSI Construction Kit; CSM #K209244, Poly White kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-993-2012;
 
95) ANSI Construction Kit; CSM #K209246, Poly White kit containing 2 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-994-2012;
 
96) Restaurant First Aid Kit; CSM #K209316, Metal kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-995-2012;
 
97) Restaurant First Aid Kit; CSM #K209318, Poly White kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-996-2012;
 
98) ANSI Restaurant Kit; CSM #K209324, Metal kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-997-2012;
 
99) ANSI Restaurant Kit; CSM #K209326, Poly White kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-998-2012;
 
100) Fayette/Coweta First Aid Kit; CSM #K209505, Poly White Box labeled with the Certified Safety Mfg. logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-999-2012;
 
101) UB Insect Sting Kit; CSM #K216022, Unit Box kit containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1000-2012;
 
102) PB Insect Sting Kit; CSM #K216024, Plastic Box kit containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1001-2012;
 
103) Verizon First Aid Kit; CSM #K245002, kit with logo containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1002-2012;
 
104) Locomotive First Aid Kit; CSM #K299000, kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1003-2012;
 
105) LPEK First Aid Kit; CSM #K401060, Poly White Box labeled with the Certified Safety Mfg. logo; containing 3 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1004-2012;
 
106) Enbridge First Aid Kit; CSM #K604033, kit with 2 color logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall D-1005-2012;
 
107) Enbridge First Aid Kit; CSM #K604035, kit with 2 color logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1006-2012;
 
108) City of Sioux city IA-Bekins First Aid Kit; CSM #K604064, kit with logo containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall #
D-1007-2012;
 
109) Bonneville Power First Aid Kit w/Logo; CSM #K604073, Metal Box labeled Property of Bonneville Power Administration, First Aid Kit; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1008-2012;
 
110) Kiewit Construction Omaha First Aid Kit; CSM #K604077, kit with logo containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1009-2012;
 
111) FairPoint First Aid Kit; CSM #K604095, kit with 1 color logo containing 2 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1010-2012;
 
112) Rally First Aid Kit; CSM #K605118, kit with logo containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1011-2012;
 
113) DLX Deluxe w/ BBP, No Meds, Cabinet; CSM #K605153, 5 Shelf Cabinet labeled with the Certified Safety Mfg. logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-1012-2012;
 
114) Jr. Trauma Kit, Orange/Red; CSM #K605156, Jr. Trauma Box labeled with the Certified Safety Mfg. logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1013-2012;
 
115) Fire Department Kit; CSM #K605203, metal kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1014-2012;
 
116) Rally First Aid Kit; CSM #K605207, black nylon bag with logo containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Mfg. for: Certified Safety Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1015-2012;
 
117) A DeZign First Aid Kit; CSM #K606225, Ziplock bag containing 4 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1016-2012;
 
118) FAC-4 General Fire First Aid Cabinet; CSM #K606232, cabinet with 2 color logo containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-1017-2012;
 
119) Electrician First Aid Kit; CSM #K606241, kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1018-2012;
 
120) Texas Gas w/Logo; CSM #K606286, Metal Box labeled Texas Gas Transmission, LLC, First Aid; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1019-2012;
 
121) Uline w/Logo; CSM #K606299, Poly White Box labeled ULINE First Aid Kit, H-1294, uline.com, 1-800-295-5510; containing 3 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall #
D-1020-2012;
 
122) Rail Crew Express First Aid Kit; CSM #K606315, kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1021-2012;
 
123) CSX First Aid Kit w/Logo; CSM #K606995, Metal Box labeled with CSX logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1022-2012;
 
124) CSX First Aid Kit w/Logo; CSM #K606996, Poly White Box labeled with CSX logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1023-2012;
 
125) CSX First Aid Kit w/Logo; CSM #K606997, Metal Box labeled with CSX logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall #
D-1024-2012;
 
126) CSX First Aid Kit w/Logo; CSM #K606998, Poly White Box labeled with CSX logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description.
Recall # D-1025-2012;
 
127) Mini First Aid Pouch Kit; CSM #K607025, red nylon bag containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1026-2012;
 
128) Santee Cooper First Aid Kit with Infection Control Kit; CSM #K608001, kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1027-2012;
 
129) Snake Bite Kit without Lancet; CSM #K608002, kit containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1028-2012;
 
130) Metra First Aid Kit; CSM #K608002, Ziplock bag containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1029-2012;
 
131) CLX NSTEC; CSM #K608036, 3 Shelf Cabinet labeled with Certified Safety Mfg. logo; containing 1 x 25-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", Reorder R233-096, UPC 7 66588 33096 9; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-1030-2012;
 
132) FAC-3 First Aid Cabinet; CSM #K608044, cabinet containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-1031-2012;
 
133) T-Mobile First Aid Kit; CSM #K608068, kit containing 2 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1032-2012;
 
134) TPartsmaster Deluxe Cabinet; CSM #K609030; 3 Shelf Cabinet with the Certified Safety Mfg. logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-1033-2012;
 
135) USA Aquatices First Aid Kit; CSM #K609037; kit with logo containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1034-2012;
 
136) R.R. Vehicle First Aid Kit; CSM #K609051; kit with logo containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1035-2012;
 
137) R.R. Locomotive First Aid Kit; CSM #K609052; Ziplock bag containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1036-2012;
 
138) R.R. Locomotive First Aid Kit; CSM #K609053; kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1037-2012;
 
139) ANSI Hospitality First Aid Cabinet; CSM #K609056; cabinet containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-1038-2012;
 
140) FAC-3 CJ Mahan First Aid Cabinet; CSM #K609066; cabinet containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-1039-2012;
 
141) Prairie State Generating First Aid Kit; CSM #K609069; kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1040-2012;
 
142) Clarkson Construction First Aid Kit; CSM #K609078; kit with logo containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1041-2012;
 
143) FAC-4 Hensel Phelps First Aid Cabinet; CSM #K609079; cabinet containing 1 x 25-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", Reorder R233-096, UPC 7 66588 33096 9; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description.
Recall # D-1042-2012;
 
144) Extra Large First Aid Pouch Kit; CSM #K610005; red nylon kit containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1043-2012;
 
145) National Safety First Aid Kit; CSM #K610009; kit with logo containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1044-2012;
 
146) National Safety First Aid Kit; CSM #K610010; kit with logo containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1045-2012;
 
147) ANSI LPEK 10 Person First Aid Kit; CSM #K610027; Poly White kit containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1046-2012;
 
148) ANSI LPEK 10 Person First Aid Kit; CSM #K610028; Metal kit containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1047-2012;
 
149) ANSI LPEK 25 Person First Aid Kit with Eye Wash; CSM #K610029; Poly White kit containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1048-2012;
 
150) ANSI LPEK 25 Person First Aid Kit with Eye Wash; CSM #K610030; Metal kit containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1049-2012;
 
151) ANSI LPEK 25 Person First Aid Kit; CSM #K610031; Poly White kit containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1050-2012;
 
152) ANSI LPEK 25 Person First Aid Kit; CSM #K610032; Metal kit containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1051-2012;
 
153) ANSI LPEK 50 Person First Aid Kit; CSM #K610033; Poly White kit containing 3 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1052-2012;
 
154) ANSI LPEK 50 Person First Aid Kit; CSM #K610034; Metal kit containing 3 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1053-2012;
 
155) Ring Container Cabinet; CSM #K610036; 4 Shelf Cabinet with the Certified Safety Mfg. logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-1054-2012;
 
156) New Zealand Construction First Aid Kit; CSM #K610037; Poly White kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1055-2012;
 
157) Curtis Fleming Fishing Pouch First Aid Kit; CSM #K610044; pouch with logo containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1056-2012;
 
158) Deluxe Cabinet, w/BBP, No Meds; CSM #K610045; 3 Shelf Cabinet labeled a) with the Certified Safety Mfg. logo; b) Brigade, Pro-Grade Construction Products Available At, HD Supply, White Cap Construction Supply; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-1057-2012;
 
159) Shell Pipeline; CSM #K610058; 3 Shelf Cabinet labeled with the Certified Safety Mfg. logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-1058-2012;
 
160) Duke Energy Cabinet; CSM #K610061; 4 Shelf Cabinet labeled with the Certified Safety Mfg. logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the cabinet also contains other components not listed in this product description. Recall # D-1059-2012;
 
161) APC First Aid Kit; CSM #K610066; kit with 2 color logo containing 6 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1060-2012;
 
162) Casco 10 Person First Aid Kit; CSM #K610073; kit with 3 color logo containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1061-2012;
 
163) Casco 25 Person First Aid Kit; CSM #K610074; kit with 3 color logo containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1062-2012;
 
164) Casco 50 Person First Aid Kit; CSM #K610075; kit with 3 color logo containing 3 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1063-2012;
 
165) Laclede Gas w/Logo; CSM #K610078; Metal Box labeled Laclede Gas, The Original Green Energy, with the Laclede Gas logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1064-2012;
 
166) Mid-Continent First Aid Kit; CSM #K610090; kit with logo containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1065-2012;
 
167) Mid-Continent First Aid Kit; CSM #K610091; kit with logo containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1066-2012;
 
168) US Pipe First Aid Kit; CSM #K610096; kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1067-2012;
 
169) Entergy First Aid Kit; CSM #K610100; kit with logo containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1068-2012;
 
170) EMT Solutia First Responder; CSM #K610102; Red Cordovia Bag containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1069-2012;
 
171) Kern River Gas First Aid Kit; CSM #K610708; kit containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1070-2012;
 
172) UP-Vehicle Refill First Aid Kit; CSM #KR201417; kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1071-2012;
 
173) ANSI General Purpose First Aid Kit Refill; CSM #KR202016; kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1072-2012;
 
174) ANSI General Purpose First Aid Kit Refill; CSM #KR202017; kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1073-2012;
 
175) ANSI General Purpose First Aid Kit Refill; CSM #KR202018; kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1074-2012;
 
176) UPRR Trauma 3380-49530 Refill; CSM #KR202065; Refill kit labeled with the Certified Safety Mfg. logo; containing 1 x 25-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", Reorder R233-096, UPC 7 66588 33096 9; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1075-2012;
 
177) UPRR Refill; CSM #KR202410; Refill kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1076-2012;
 
178) ANSI Quality Refill; CSM #KR206003; Refill kit containing 5 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1077-2012;
 
179) Economy Cabinet Refill; CSM #KR206125; Refill kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1078-2012;
 
180) Standard Cabinet Refill; CSM #KR206130; Refill kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1079-2012;
 
181) CLX 100 Person Deluxe Cabinet Refill; CSM #KR206140; Refill kit labeled with the Certified Safety Mfg. logo; containing 1 x 25-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", Reorder R233-096, UPC 7 66588 33096 9; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1080-201;
 
182) FAC-4R-200 Person Deluxe Cabinet Refill; CSM #KR206152; Refill kit labeled with the Certified Safety Mfg. logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1081-2012;
 
183) Deluxe Cabinet Refill; CSM #KR206154; Refill kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1082-2012;
 
184) Office Refill; CSM #KR206156; Refill kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1083-2012;
 
185) FAC-5R-Deluxe Cabinet Refill; CSM #KR206162; Refill kit labeled with the Certified Safety Mfg. logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1084-2012;
 
186) CLX-100R-Person-Economy Refill; CSM #KR206180; Refill kit labeled with the Certified Safety Mfg. logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1085-2012;
 
187) Deluxe Cabinet Refill; CSM #KR206210; Refill kit labeled with the Certified Safety Mfg. logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1086-2012;
 
188) CLX-100 Person Economy Refill; CSM #KR206212; Refill kit labeled with the Certified Safety Mfg. logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1087-2012;
 
189) New Jersey Rail Refill; CSM #KR208003; Refill kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1088-2012;
 
190) TRMK-R Trauma Kit Refill; CSM #KR209061; Refill kit labeled with the Certified Safety Mfg. logo; containing 1 x 25-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", Reorder R233-096, UPC 7 66588 33096 9; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1089-2012;
 
191) FAMC-X Medicinal Cabinet Refill; CSM #KR209090; Refill kit labeled with the Certified Safety Mfg. logo; containing 1 x 25-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", Reorder R233-096, UPC 7 66588 33096 9; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1090-2012;
 
192) 16 Unit-Shop Refill; CSM #KR209150; Refill kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1091-2012;
 
193) ANSI Construction Kit Refill; CSM #KR209150; Refill kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1092-2012;
 
194) ANSI Construction Kit Refill; CSM #KR209236; Refill kit containing 2 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1093-2012;
 
195) ANSI Restaurant Kit Refill; CSM #KR209324; Refill kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1094-2012;
 
196) 24 Unit Refill - Police Department; CSM #KR605204; Refill kit containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1095-2012;
 
197) EMT Trauma First Aid Kit Refill; CSM #KR606279; Refill kit labeled with the Certified Safety Mfg. logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1096-2012;
 
198) ANSILPEK 10 Person Refill; CSM #KR610027; Refill kit containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1097-2012;
 
199) ANSILPEK 25 Person Refill with Eye Wash; CSM #KR610029; Refill kit containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1098-2012;
 
200) ANSILPEK 25 Person Refill; CSM #KR610031; Refill kit containing 2 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, ;Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1099-2012;
 
201) ANSILPEK 50 Person Refill; CSM #KR610033; Refill kit containing 3 x 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product description. Recall # D-1100-2012;
 
202) FAC-3R Deluxe Cabinet w/ BBP -No Meds-Refill; CSM #KR610045; Refill kit labeled with the Certified Safety Mfg. logo; containing 1 x 10-count wipes per box labeled as PVP Iodine Wipe-Ups, 1" x 2", 752, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%,Cat. No. 10-3201, NDC 50730-3201-1; the kit also contains other components not listed in this product. Recall # D-1101-2012;
 
203) PVP Iodine Wipe-Ups, 1" x 2", CSM #210029, 752CG, 10-count wipes per box, Mfg. for: Certified Safety Mfg., Inc, Kansas City, MO 64127, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Triad Group, Inc., 700 West North Shore Dr., Hartland, WI 53029 USA, Cat. No. 10-3201, NDC 50730-3201-1. CSM #210029 is the same product as CSM #213005 with the exception of having a double wrap around the box of CSM #213005. Recall # D-1102-2012;
 
204) PVP Iodine Wipe-Ups, 1" x 2", CSM #213005, 752, 10-count wipes per box, Reorder R213-005; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1. Recall # D-1103-2012;
 
205) PVP Iodine Wipe-Ups, 1" x 2", CSM #R233096, 25-count wipes per box, Reorder R233-096, UPC 7 66588 33096 9; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1. Recall # D-1104-2012;
 
206) PVP Iodine Wipe-Ups, 1" x 2", CMS #233097, 100-count wipes per box, Reorder R233-097, UPC 7 66588 33097 6; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1. Recall # D-1105-2012;
 
207) PVP Iodine Wipe-Ups, 1" x 2", CSM #233098, 50-count wipes per box, Reorder R233-098, UPC 7 66588 33098 3; each Triad individual wipe is a 1-count pad in foil pouch labeled as Povidone Iodine Prep Pad (povidone iodine) 10%, Cat. No. 10-3201, NDC 50730-3201-1. Recall # D-1106-2012
CODE
PVP Pad Lot #: 8B10, 8B09, 8B40, Exp 02/11; 8E11, 8E76, 8E94, Exp 05/11; 8G439, Exp 07/11; 8H453, Exp 8/11; 8J460, Exp 09/11; 9A34, 9A12, Exp 01/12; 9D479, Exp 04/12, 9E25, Exp 05/12; 9J17, Exp 09/12; 9L22, Exp 11/12, 9M37, Exp 12/12; 0F11, Exp 06/13; 0K12, Exp 10/13; 0L35, Exp 11/13, or any other lot containing Triad Groups brand of PVP wipes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Certified Safety Mfg Inc., Kansas City, MO, by letters dated March 20, 2011.
Manufacturer: Certified Safety Mfg Inc., Kansas City, MO;
Manufacturer: H & P Industries, Inc., Hartland, WI.
Firm initiated recall is ongoing.
REASON
Microbial Contamination of Non-Sterile Products: The products contain povidone iodine prep pads which were recalled by the supplier.
VOLUME OF PRODUCT IN COMMERCE
188,797 boxes and kits
DISTRIBUTION
Nationwide, Puerto Rico, New Zealand, and Jamaica
___________________________________
PRODUCT
VELCADE (bortezomib) for Injection, 3.5 mg/vial, For Intravenous Use Only, Rx Only, Single Use Vial, NDC #: 63020-049-01. Recall # D-1107-2012
CODE
Lot #s: Exp. Date: 100747 04/30/2012; 100748 05/31/2012; 100919 06/30/2012; 100964 04/30/2013; 100963 05/31/2013; 101107 09/30/2013; 101106 11/30/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Millennium Pharmaceuticals Inc. Cambridge, MA, by letter on December 7, 2011.
Manufacturer: Ben Venue Laboratories Inc., Bedford, OH. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: During recent good manufacturing practice (GMP) inspections conducted at BVL by multiple regulatory authorities, including the FDA, manufacturing and quality concerns were identified, including sterility assurance concerns and issues related to the potential presence of particulates. Based on these findings, Millenium is conducting a voluntary recall as a precautionary measure.
VOLUME OF PRODUCT IN COMMERCE
252,232 Vials
DISTRIBUTION
Nationwide; Guam, Virgin Islands
___________________________________
PRODUCT
MD-Gastroview, Diatrizoate Meglumine and Diatrizoate Sodium Solution U.S.P., a) 120 mL bottle (NDC 0019-4816-05), b) 240mL bottle, Rx Only. Recall # D-1108-2012
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mallinckrodt Inc., Hazelwood, MO, by letter on/about July 8, 2011.  
Manufacturer: Covidien, Raleigh, NC. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: The product does not meet the requirements of the USP Antimicrobial Effectiveness test.
VOLUME OF PRODUCT IN COMMERCE
16,260 bottles
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
5% Dextrose Injection, USP, 250 mL Flexible Container, Each 100mL contains Dextrose Hydrous, 1 container per overwrap, 24 overwraps per shipping container, Rx only, NDC 0409-7922-02. Recall # D-1110-2012
CODE
Lot Number: 95-067-JT
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letter on August 18, 2011. 
Manufacturer: Hospira, Inc., Austin, TX. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility; potential for bags to leak.
VOLUME OF PRODUCT IN COMMERCE
463,008 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
HydrALAzine Hydrochloride Tablets, USP, 25 mg, 1000-count tablets per bottle, Rx only; NDC 50111-327-03, barcode 3 5011132703 0. Recall # D-1111-2012
CODE
Lot # 315809, Exp 01/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on November 11, 2011. 
Manufacturer: Pliva Krakow S.A., Krakow, Poland. Firm initiated recall is ongoing.
REASON
Low Tablet Weight: There is the potential that some tablets may not conform to weight specifications.
VOLUME OF PRODUCT IN COMMERCE
3,832 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Deprizine FusePaq Kit for Oral Suspension (ranitidine hydrochloride 16.8 mg/mL [15 mg/mL ranitidine], in oral suspension - compounding kit). Recall # D-1112-2012
CODE
PL 167, PL 168
RECALLING FIRM/MANUFACTURER
Fusion Pharmaceuticals LLC, Camarillo, CA, by letter or telephone on October 26, 2011. Firm initiated recall is ongoing.
REASON
CGMP Deviations: Fusion Pharmaceuticals LLC, is voluntarily recalling two lot numbers of Deprizine Fusepaq (Kit for Oral Suspension), because they have not validated the data to support a 12 month expiration date.
VOLUME OF PRODUCT IN COMMERCE
251 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Metformin, Hydrochloride, Tablets USP, 1000 mg, Rx only, 100 Tablets, NDC 67877-221-03, UPC 3 6877 22101 4. Recall # D-1113-2012;
 
2) Metformin, Hydrochloride, Tablets USP, 850mg, Rx only, 100 Tablets, NDC 67877-218-01, UPC 3 6877 21801 4. Recall # D-1114-2012
CODE
1) Lots 1140210, 1140212, 1140213, Exp.01/13; 1140376, 1140377, 1140378; Exp. 02/13;
 
2) Lots 1140174, 1140182,1140183; Exp. 01/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alkem Laboratories Ltd, Mumbai, India, by letter dated July 6, 2011.
Manufacturer: Alkem Laboratories Limited, Daman, India. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution: Dissolution trend observed on all stability batches of Metformin Hydrochloride tablets USP 1000mg indicates that the batches may not meet specification through shelf life.
VOLUME OF PRODUCT IN COMMERCE
69,610 bottles
DISTRIBUTION
NJ
___________________________________
PRODUCT
Isovue-250 (iopamidol injection 51%) 50 mL, Single Dose Vial, Rx Only, NDC: 0270-1317-05. Recall # D-1115-2012
CODE
Lot #: OF68266, Exp 06/2013
RECALLING FIRM/MANUFACTURER
Bracco Diagnostic Inc., Princeton, NJ,  
REASON
Lack of Assurance of Sterility: Several bottle necks of one lot of Isovue -250 were observed to contain cracks just below the crimping cap.
VOLUME OF PRODUCT IN COMMERCE
18, 050 Vials
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Wellbutrin XL 150 mg 90 Tablets Rx only. NDC 64455-730-90. Recall # D-1109-2012
CODE
Lot #11F060P
RECALLING FIRM/MANUFACTURER
Biovail Corp., Steinbach Manitoba, Canada, by letters dated October 28, 2011. Firm initiated recall is ongoing.  
REASON
Failed USP Dissolution Test Requirement.
VOLUME OF PRODUCT IN COMMERCE
822 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Verapamil HCI Extended-release capsules, 180 mg, 100-count capsules per bottle, Rx only; NDC 0378-6380-01. Recall # D-1116-2012
CODE
Lot # 3018380, Exp 03/12  
RECALLING FIRM/MANUFACTURER
Mylan Pharmaceuticals Inc., Morgantown, WV, by letters dated December 9, 2011. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirements: Routine stability testing for a distributed pharmaceutical yielded out of specification dissolution results.
VOLUME OF PRODUCT IN COMMERCE
3,723 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0324-12
CODE
Units: W115111232546O; W115111232546O; W115111232546O
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc - Birmingham Region, Birmingham, AL, by fax on October 5, 2011. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced which did not meet the requirements for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0326-12
CODE
Unit: W056311045293
RECALLING FIRM/MANUFACTURER
St Mary's Hospital and Medical Center, Inc., Grand Junction, CO, by e-mail on September 23, 2011. Firm initiated recall is complete.
REASON
Blood product, labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0327-12
CODE
Unit: W141607653688
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by electronic notification on December 13, 2007.  
Manufacturier: Puget Sound Blood Center, Vancouver, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who used a needle for self injection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0329-12
CODE
Unit: 4278190
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by facsimile on November 6, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AK
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0331-12
CODE
Unit: 20LN79038
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Boise, ID, by facsimile or electronic notification on November 20, 2007. Firm initiated recall is complete.  
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ID, CA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0332-12;
2) Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-0333-12
CODE
1) and 2) Unit: W141607417505
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by facsimile on November 13, 2007 or letter dated December 21, 2007.  
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-0334-12;
2) Red Blood Cells. Recall # B-0335-12
CODE
1) and 2) Unit: W141607215763
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by letter dated December 21, 2007. 
Manufacturer: Puget Sound Blood Center and Program, Lynnwood, WA. Firm initiated recall is complete.  
REASON
Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA, Austria
___________________________________
PRODUCT
1) Recovered Plasma, Recall # B-0336-12;
2) Red Blood Cells. Recall # B-0337-12;
3) Red Blood Cells Leukocytes Reduced. Recall # B-0338-12;
4) Fresh Frozen Plasma. Recall # B-0339-12
CODE
1) and 3) Unit: W141607212093;
2) and 4) Unit: W141607215762
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter dated December 21, 2007. 
Manufacturer: Puget Sound Blood Center and Program, Lynnwood, WA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
WA, Austria
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0340-12
CODE
Units: W141607216961, W141607215023
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter dated November 28, 2007. 
Manufacturer: Puget Sound Blood Center and Program, Lynnwood, WA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0341-12
CODE
Unit: W141607112651
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by letter dated August 8, 2007.
Manufacturer: Puget Sound Blood Center and Program, Bellingham, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0358-12
CODE
Units: W088411538996, W088411528952, W088411518339
RECALLING FIRM/MANUFACTURER
Blood Bank Of Hawaii, Honolulu, HI, by letter dated October 31, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
HI
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0359-12;
2) Plasma Frozen within 24 hours (FP24). Recall # B-0360-12
CODE
1) and 2) Unit: W287011003550
RECALLING FIRM/MANUFACTURER
Lifesource, Rosemont, IL, by telephone and facsimile on September 27, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Platelets. Recall # B-0361-12
CODE
Unit: W035211298924I
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by facsimile on November 1, 2011 and by letter dated November 9, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Plasma Frozen within 24 hours (FP24). Recall # B-0363-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0364-12
CODE
1) Unit: 12FE77546;
2) Units: 12FE77546, 12FJ87691, 12LW13437
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by facsimile on October 1, 2011 and by letter dated October 1, 2011.
Manufacturer: The American Red Cross Blood Services, Carolinas Region, Winston Salem, NC. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TN, SC, GA
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-0366-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0367-12
CODE
1) and 2) Unit: 12FP11679
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC, by facsimile on October 14, 2011 and by letter dated October 14, 2011. 
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
SC, NC, CA
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0328-12
CODE
Unit: W141607374966
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by letter dated December 4, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a vaccine prior to donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0330-12
CODE
Unit: 20LN79038
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Boise, ID, by facsimile or electronic notification on November 20, 2007. Firm initiated recall is complete.  
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ID, CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0365-12
CODE
Unit: 041FP65536
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by electronic notification on October 6, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0368-12
CODE
Unit: 12FP11679
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC, by facsimile on October 14, 2011 and by letter dated October 14, 2011. 
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC, NC, CA
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS I
___________________________________
PRODUCT
Shoulder Flex Massage Device Device is an electric personal massage device labeled in part: "ShoulderFlex Deep-kneading Shiatsu* Model #SH61 *Read all instructions before using the massager* **WARNING NEVER wear a necklace or similar items while using this product Made in China." Personal use massage device designed for home use to provide deep tissue massage to the neck, shoulder and back while user lies on a flat surface. Recall # Z-0172-2012
CODE
None
RECALLING FIRM/MANUFACTURER
King International, Beaverton, OR, by letter on August 25, 2011 and by press release on August 31, 2011. Firm initiated recall is ongoing.
REASON
The covered rotating mechanism can catch on user's clothing, jewelry (e.g. necklace), and hair. There have been reports of one death and strangulation associated with using the device.
VOLUME OF PRODUCT IN COMMERCE
11,934 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
AVAIRA AQUAFORM Comfort Science enfilcon A Daily Wear SPHERE Soft Contact Lenses (disposable), Rx only, STERILE --- Device Listing # D033736. Packaged: 6 Soft Contact Lenses per unit carton or trial product 3 pack. AVAIRA (enfilcon A) SPHERE soft contact lenses are indicated for the correction of ametropia (myopia or hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Recall # Z-0350-2012
CODE
Packaged lot numbers: 10433000002003, 10433000002503, 10433000003040, 10433000004002, 10433000004005, 10433000004504, 10433000004509, 10433000004519, 10433000004522, 10433000005005, 10433000005026, 10433000005028, 10433000005030, 10433000005507, 10433000005513, 10433000005516, 10433000005517, 10433000006005, 10433000006007, 10433000006026, 10433000006028, 10433000006030, 10433000006032, 10433000006040, 10433000006505, 10433000006510, 10433000006511, 10433000006515, 10433000006516, 10433000006517, 10433000007007, 10433000007010, 10433000007028, 10433000007030, 10433000007032, 10433000007038, 10433000007506, 10433000007508, 10433000007509, 10433000007511, 10433000007515, 10433000008004, 10433000008011, 10433000008028, 10433000008030, 10433000008032, 10433000008038, 10433000008506, 10433000008508, 10433000008512, 10433000009026, 10433000009028, 10433000009034, 10433000009036, 10433000009506, 10433000009512, 10433000010008, 10433000010016, 10433000010026, 10433000010034, 10433000010508, 10433000011012, 10433000011034, 10433000012017, 10433000012019, 10433000012022, 10433000012024, 10433000013022, 10433000013023, 10433000013024, 10433000014020, 10433000014021, 10433000014023, 10433000015020, 10433000016021, 10433000016023, 10433050000502, 10433050000514, 10433050002030, 10433050003003, 10433050004009, 10433050005009, 10433050005016, 10433050006007, 10433050007007, 10433050008007, 10433050009005, 10433050009006, 10433050010006, 10433050011006, 10433050012006, 10435000001519, 10435000002507, 10435000002515, 10435000002517, 10435000003042, 10435000003518, 10435000004512, 10435000004514, 10435000004516, 10435000005034, 10435000005508, 10435000006034, 10435000006506, 10435000008002, 10435000011028, 10435000011030, 10435000012021, 10435000012028, 10435000012030, 10435000013003, 10435000014021, 10435000014023, 10435000014024, 10435000014028, 10435000014030, 10435000015030, 10435000016003, 10435000016022, 10435000016026, 10435000016030, 10435000017010, 10435000017016, 10435000017022, 10435000017028, 10435000018005, 10435000018017, 10435000018023, 10435000018024, 10435000019003, 10435000019009, 10435000019026, 10435000020003, 10435000020005, 10435000020006, 10435000020010, 10435000020019, 10435000020024, 10435000021004, 10435000021005, 10435000021009, 10435000021014, 10435000022005, 10435000023004, 10435000023005, 10435000023006, 10435000023007, 10435000023009, 10435000023015, 10435000023017, 10435000024004, 10435000024006, 10435000025006, 10435000025011, 10435000025013, 10435000026004, 10435000026005, 10435000026006, 10435000026007, 10435000026008, 10435000027006, 10435000027007, 10435000027011, 10435000028006, 10435000029006, 10435000029008, 10435000030008, 10435000031008, 10435050000028, 10435050001003, 10435050001026, 10435050001034, 10436000003040, 10436000004002, 10436000004004, 10436000004030, 10436000004516, 10436000005023, 10436000005026, 10436000005030, 10436000005518, 10436000006004, 10436000006017, 10436000006021, 10436000006024, 10436000006513, 10436000006514, 10436000007009, 10436000007012, 10436000007013, 10436000007016, 10436000007020, 10436000007024, 10436000007514, 10436000008005, 10436000008006, 10436000008012, 10436000008013, 10436000008014, 10436000009005, 10436000009007, 10436000009013, 10436000010005, 10436000010006, 10436000010007, 10436000010008, 10436000011005, 10436000011006, 10436000012006, 10436000012008, 10436050000026, 10436050001002, 10436050001510, 10613000003003, 10613000003010, 10613000004002, 10613000004016, 10613000004017, 10613000004514, 10613000005005, 10613000005007, 10613000005011, 10613000005036, 10613000005511, 10613000005515, 10613000006005, 10613000007017, 10613050000002, 10613050000005, 10613050000013, 10613050000019, 10613050000021, 10613050000022, 10613050000518, 10613050001003, 10613050001004, 10613050001005, 10613050001006, 10613050001007, 10613050001008, 10613050001009, 10613050001013, 10613050001014, 10613050001015, 10613050001018, 10613050001021, 10613050002004, 10613050002006, 10613050002020, 10613050003004, 10616000002042, 10616000004014, 10616000004036, 10616000004038, 10616000004517, 10616000004519, 10616000005009, 10616000005012, 10616000005018, 10616000005034, 10616000005514, 10616000005516, 10616000006008, 10616000006010, 10616000006013, 10616000006016, 10616000006017, 10616000006030, 10616000006510, 10616000006512, 10616000007003, 10616000007008, 10616000007009, 10616000007030, 10616000008003, 10616000008005, 10616000008010, 10616000008015, 10616000008020, 10616000008023, 10616000008024, 10616000008030, 10616000009005, 10616000009017, 10616000009024, 10616000009028, 10616000009030, 10616000010003, 10616000010005, 10616000010010, 10616000010021, 10616000010024, 10616000011003, 10616000011004, 10616000011007, 10616000011010, 10616000012002, 10616000012004, 10616000012005, 10616000012026, 10616000013004, 10616000013006, 10616000013026, 10616000014002, 10616050000008, 10616050000012, 10616050000013, 10616050000021, 10616050000032, 10616050000513, 10616050001004, 10616050001023, 10616050002004, 10616050002007, 10616050003005, 10796000003006, 10796000003024, 10796000003028, 10796000003030, 10796000004026, 10813000002003, 10813000002008, 10813000002010, 10813000002012, 10813000002014, 10813000002018, 10813000002022, 10813000002026, 10813000002030, 10813000002036, 10813000002040, 10813000003004, 10813050000006, 456405000016, 456405000035, 456405000060, 456405000214, 456405000313, 456405000328, 456405000403, 456405000504, 456405000510, 456405000520, 456405000607, 456405000620, 456405000708, 456405000709, 456405000717, 456405000805, 456405000808, 456405000809, 456405000905, 456405000906, 456405000909, 456405001005, 456405001006, 456405001106, 456407002233, 456407003169, 456407003551, 456407003835, 456407004434, 456407005165, 456407005934, 456407006255, 456407006736, 456407006759, 456407007032, 456407007132, 456407007459, 456407007464, 456407007664, 456407007752, 456407007757, 456407008066, 456407008154, 456407008661, 456407008862, 456407009662, 456407010858, 456407012830, 456407015130, 456407017028, 456407032626, 456407035002, 456407035026, 456407035223, 456407035523, 456407036702, 456407040418, 456407041322, 456407043413, 456407048014, 456407049713, 456407049824, 456407057910, 456407060103, 456407061510, 456407063915, 456407081207, 456407084904, 456407090505, 456407092206, 456407093304, 456407095305, 456407096506, 456407100004, 458505000028, 458505000062, 458507003835, 458507005368, 458507008057, 458507035523, 458507058711, 458507059811, 458507064215, 458605000226, 458605000410, 458605000419, 458605000510, 458605000610, 458605000613, 458605000615, 458605000712, 458605000713, 458605000809, 458605000813, 458605000814, 458605000815, 458605000816, 458605000908, 458605000911, 458605000914, 458605001004, 458605001108, 458605001116, 458605001204, 458605001205, 458605001206, 458605001207, 458605001304, 458605001305, 458605001306, 458605001406, 458605001506, 458605001606, 458605001607, 458605001706, 458605001707, 458605001806, 458605001807, 458605001906, 458607002651, 458607002933, 458607003232, 458607003335, 458607003732, 458607004865, 458607005268, 458607007257, 458607007861, 458607007866, 458607008064, 458607008154, 458607008432, 458607009262, 458607009501, 458607010730, 458607012458, 458607013130, 458607014030, 458607033726, 458607034902, 458607045121, 458607045221, 458607047424, 458607048814, 458607049014, 458607049824, 458607051816, 458607063515, 458607099805, 458607116806, 458705000051, 458705000161, 458705000163, 458705000226, 458705000259, 458705000352, 458705000366, 458705000460, 458705000466, 458705000532, 458705000628, 458705000632, 458705000728, 458705000730, 458705000732, 458705000807, 458705000813, 458705000828, 458705000913, 458705000914, 458705001009, 458705001108, 458705001118, 458705001210, 458705001402, 458705001411, 458705001502, 458705001823, 458705002221, 458705002903, 458705002906, 458705003005, 458705003006, 458705003105, 458705003106, 458705003205, 458705003206, 458707002233, 458707002633, 458707002651, 458707002751, 458707002969, 458707003335, 458707004234, 458707004534, 458707004865, 458707004867, 458707005265, 458707005672, 458707005959, 458707006232, 458707006253, 458707006255, 458707006457, 458707006557, 458707006632, 458707006736, 458707006755, 458707006852, 458707006866, 458707006932, 458707006952, 458707007063, 458707007257, 458707007459, 458707007664, 458707007861, 458707007866, 458707008066, 458707008154, 458707008560, 458707008661, 458707008760, 458707008862, 458707009262, 458707009360, 458707009662, 458707009930, 458707009962, 458707010360, 458707010630, 458707010656, 458707010858, 458707010956, 458707011756, 458707012030, 458707012256, 458707012258, 458707012430, 458707013928, 458707014030, 458707014628, 458707026126, 458707027026, 458707028226, 458707031302, 458707032302, 458707033102, 458707033926, 458707034423, 458707034623, 458707034626, 458707034902, 458707034923, 458707039118, 458707039218, 458707042917, 458707043413, 458707044517, 458707046921, 458707047221, 458707047224, 458707047319, 458707048014, 458707049924, 458707050013, 458707056112, 458707056409, 458707058010, 458707059811, 458707060008, 458707061510, 458707062820, 458707063008, 458707064915, 458707065215, 458707072307, 458707082904, 458707090304, 458707092904, 458707093106, 458707093804, 458707094005, 458707095704, 458707096005, 458707099005, 458707103306, 458707109006, 489405000057, 489405000130, 489405000217, 489405000218, 489405000230, 489405000260, 489405000263, 489405000302, 489405000328, 489405000362, 489405000416, 489405000418, 489405000426, 489405000428, 489405000516, 489405000521, 489405000522, 489405000528, 489405000622, 489405000724, 489405000803, 489405000809, 489405000812, 489405000907, 489405000910, 489405000913, 489405001010, 489405001107, 489405001109, 489405001110, 489405001113, 489405001204, 489405001207, 489405001304, 489405001305, 489405001307, 489405001407, 489405001505, 489405001605, 489405001606, 489405001705, 489405001706, 489405001806, 489405001906, 489405002006, 489407002969, 489407003169, 489407003232, 489407003335, 489407003551, 489407004067, 489407004167, 489407004534, 489407004632, 489407004734, 489407005265, 489407005665, 489407005672, 489407005832, 489407006053, 489407006557, 489407006653, 489407006755, 489407006866, 489407006932, 489407007464, 489407007657, 489407007664, 489407007752, 489407007964, 489407008057, 489407008066, 489407008154, 489407008561, 489407008862, 489407009162, 489407009360, 489407009930, 489407010101, 489407010362, 489407010430, 489407010656, 489407010858, 489407016828, 489407018428, 489407033326, 489407034223, 489407035002, 489407044417, 489407046819, 489407046924, 489407047114, 489407048814, 489407049924, 489407055509, 489407058911, 489407061510, 489407062808, 489407064208, 489407086504, 489407094405, 489407100306, 489407102304, 489407106706, 491305000059, 491305000066, 491305000133, 491305000156, 491305000254, 491305000262, 491305000432, 491305000460, 491305000464, 491305000528, 491305000530, 491305000628, 491305000630, 491305000728, 491305000730, 491305000828, 491305000830, 491305000928, 491305001023, 491305001026, 491305001104, 491305001122, 491305001126, 491305001204, 491305001217, 491305001222, 491305001223, 491305001226, 491305001304, 491305001310, 491305001317, 491305001324, 491305001326, 491305001404, 491305001408, 491305001410, 491305001418, 491305001424, 491305001426, 491305001505, 491305001510, 491305001518, 491305001519, 491305001526, 491305001605, 491305001607, 491305001608, 491305001609, 491305001610, 491305001611, 491305001613, 491305001626, 491305001705, 491305001707, 491305001712, 491305001713, 491305001807, 491305001808, 491305001809, 491305001810, 491305001816, 491305001907, 491305001916, 491305001920, 491305002006, 491305002007, 491305002016, 491305002106, 491305002107, 491305002206, 491305002306, 491305002506, 491307001633, 491307002873, 491307002969, 491307003169, 491307003333, 491307003551, 491307003835, 491307004167, 491307004734, 491307004865, 491307005368, 491307005472, 491307006253, 491307006457, 491307006536, 491307006755, 491307006759, 491307006866, 491307007032, 491307007063, 491307007332, 491307007752, 491307007866, 491307008064, 491307008154, 491307008157, 491307008560, 491307008561, 491307008661, 491307008962, 491307010101, 491307010162, 491307010362, 491307010858, 491307012458, 491307012556, 491307018728, 491307019628, 491307033602, 491307046713, 491307046924, 491307048216, 491307057711, 491307058609, 491307059909, 491307063408, 491307063520, 491307078007, 491307093106, 508205000533, 508205000633, 508205000634, 508205000637, 508205000732, 508205000733, 508205000734, 508205000736, 508205000832, 508205000835, 508205000932, 508205001032, 508205001101, 508205001132, 508205001228, 508205001230, 508205001328, 508205001330, 508205001428, 508205001430, 508205001502, 508205001528, 508205001530, 508205001602, 508205001603, 508205001626, 508205001628, 508205001630, 508205001702, 508205001726, 508205001728, 508205001730, 508205001802, 508205001828, 508205001830, 508205001902, 508205001903, 508205001926, 508205001928, 508205002002, 508205002003, 508205002026, 508205002102, 508205002103, 508205002126, 508205002203, 508205002226, 508205002303, 508205002326, 508205002403, 508205002423, 508205002426, 508205002503, 508205002523, 508205002526, 508205002603, 508205002621, 508205002626, 508205002721, 508205002723, 508205002724, 508205002726, 508205002823, 508205002826, 508205002921, 508205002926, 508205003019, 508205003020, 508205003021, 508205003022, 508205003023, 508205003024, 508205003026, 508205003120, 508205003122, 508205003224, 508205003320, 508205003322, 508205003324, 508205003418, 508205003420, 508205003424, 508205003518, 508205003519, 508205003524, 508205003618, 508205003620, 508205003718, 508205003719, 508205003724, 508205003819, 508205003820, 508205003918, 508205003924, 508205004314, 508205004317, 508205004414, 508205004417, 508205004514, 508205004617, 508205004714, 508205004717, 508205004814, 508205004817, 508205004911, 508205004914, 508205005116, 508205005204, 508205005214, 508205005304, 508205005305, 508205005312, 508205005316, 508205005404, 508205005405, 508205005411, 508205005413, 508205005414, 508205005416, 508205005505, 508205005511, 508205005516, 508205005604, 508205005605, 508205005612, 508205005613, 508205005705, 508205005712, 508205005716, 508205005804, 508205005805, 508205005811, 508205005812, 508205005813, 508205005816, 508205005904, 508205005905, 508205005913, 508205005916, 508205006004, 508205006005, 508205006011, 508205006012, 508205006013, 508205006104, 508205006105, 508205006106, 508205006108, 508205006112, 508205006113, 508205006115, 508205006116, 508205006204, 508205006205, 508205006206, 508205006208, 508205006211, 508205006215, 508205006304, 508205006305, 508205006306, 508205006313, 508205006316, 508205006404, 508205006405, 508205006409, 508205006412, 508205006415, 508205006504, 508205006505, 508205006506, 508205006508, 508205006509, 508205006513, 508205006604, 508205006605, 508205006606, 508205006608, 508205006609, 508205006704, 508205006706, 508205006709, 508205006713, 508205006715, 508205006804, 508205006805, 508205006806, 508205006904, 508205006905, 508205006906, 508205006909, 508205007005, 508205007006, 508205007105, 508205007106, 508205007108, 508205007109, 508205007205, 508205007206, 508205007305, 508205007306, 508205007309, 508205007405, 508205007406, 508205007408, 508205007410, 508205007506, 508205007509, 508205007510, 508205007606, 508205007607, 508205007706, 508205007710, 508205007806, 508205007810, 508205007906, 508205007910, 508205008006, 508205008010, 508205008106, 508205008206, 508205008210, 508205008306, 508205008406, 508205008407, 508205008506, 508205008507, 508205008606, 508205008607, 508205008707, 508205008807, 508205008907, 508205009007, 508205009107, 508205009207, 508205009307, 508205009407, 508205009507, 508205009607, 508205009707, 508205009807, 508205009907, 508205010107, 508207000833, 508207002833, 508207003032, 508207003335, 508207003435, 508207030726, 508207031302, 508207032702, 508207035523, 508207039022, 508207046624, 508207049014, 508207051024, 508207053112, 508207054309, 508207054616, 508207058312, 508207058909, 508207060110, 508207061410, 508207063308, 508207090807, 508207094006, 508207096606, 508207112406, 508305000102, 508305000132, 508305000158, 508305000203, 508305000232, 508305000234, 508305000261, 508305000303, 508305000408, 508305000417, 508305000506, 508305000604, 508305000606, 508305000608, 508305000609, 508305000613, 508305000620, 508305000626, 508305000704, 508305000706, 508305000708, 508305000712, 508305000713, 508305000714, 508305000720, 508305000804, 508305000805, 508305000806, 508305000812, 508305000905, 508305000908, 508305000913, 508305000916, 508305001005, 508305001105, 508305001207, 508305001407, 508307003551, 508307004534, 508307005665, 508307005934, 508307006253, 508307006755, 508307006759, 508307006952, 508307007464, 508307008066, 508307008157, 508307008561, 508307008962, 508307009360, 508307009662, 508307010030, 508307011756, 508307012030, 508307012156, 508307014528, 508307017728, 508307026626, 508307028626, 508307032302, 508307033126, 508307034223, 508307036002, 508307046013, 508307046221, 508307048424, 508307048714, 508307048814, 508307053916, 508307055809, 508307059309, 508307085404, 508307111706, 508405000233, 508405000333, 508405000357, 508405000362, 508405000432, 508405000434, 508405000451, 508405000532, 508405000535, 508405000552, 508405000553, 508405000565, 508405000572, 508405000601, 508405000602, 508405000628, 508405000630, 508405000632, 508405000728, 508405000730, 508405000802, 508405000823, 508405000828, 508405000830, 508405000859, 508405000866, 508405000902, 508405000926, 508405000928, 508405000930, 508405001002, 508405001019, 508405001026, 508405001102, 508405001110, 508405001118, 508405001126, 508405001202, 508405001210, 508405001226, 508405001302, 508405001309, 508405001313, 508405001326, 508405001403, 508405001410, 508405001416, 508405001503, 508405001506, 508405001509, 508405001517, 508405001520, 508405001606, 508405001609, 508405001616, 508405001617, 508405001624, 508405001706, 508405001707, 508405001711, 508405001722, 508405001806, 508405001807, 508405001904, 508405001906, 508405001907, 508405001912, 508405001915, 508405002004, 508405002005, 508405002006, 508405002007, 508405002012, 508405002015, 508405002104, 508405002105, 508405002106, 508405002107, 508405002108, 508405002112, 508405002204, 508405002205, 508405002206, 508405002207, 508405002208, 508405002305, 508405002306, 508405002405, 508407000833, 508407003232, 508407003482, 508407003551, 508407003833, 508407003934, 508407004067, 508407004734, 508407005170, 508407005265, 508407005332, 508407005572, 508407005768, 508407006053, 508407006334, 508407008254, 508407009360, 508407009960, 508407010101, 508407012156, 508407012258, 508407012430, 508407012458, 508407039822, 508407045121, 508407049824, 508407055203, 508407058709, 508407058711, 508407065215, 508407094705, 639505000072, 639505000168, 639505000268, 639505000308, 639505000506, 639505000507, 639505000606, 639505000705, 639505000713, 639507002133, 639507004534, 639507007032, 639507007866, 639507007961, 639507009930, 639507010230, 639507012628, 639507017028, 639507026626, 639507035523, 639507037202, 639507039222, 639507047124, 639507051116, 639507056212, 639507060203, 639507060720, 639605000020, 639607003335, 639607004534, 639607007332, 639607010101, 639607017128, 639607062003, 639607063808, 639607087207, 639607091204, 639607091605, 639607093805, 639607101206, 639705000022, 639705000030, 639705000065, 639705000102, 639705000124, 639705000132, 639705000163, 639705000306, 639705000314, 639705000316, 639705000326, 639705000405, 639705000408, 639705000411, 639705000426, 639705000506, 639705000604, 639705000804, 639707000833, 639707002133, 639707004534, 639707004865, 639707005170, 639707005265, 639707005665, 639707006036, 639707006159, 639707006255, 639707006457, 639707006755, 639707006932, 639707006952, 639707007066, 639707007257, 639707007861, 639707008057, 639707008064, 639707008066, 639707008460, 639707008962, 639707009501, 639707009930, 639707010162, 639707010230, 639707010360, 639707010362, 639707010730, 639707010858, 639707012256, 639707012258, 639707012628, 639707012830, 639707014030, 639707014128, 639707014728, 639707017728, 639707033026, 639707033102, 639707033602, 639707033802, 639707033926, 639707034923, 639707035523, 639707037526, 639707038518, 639707040722, 639707041517, 639707042417, 639707044013, 639707044417, 639707046714, 639707046813, 639707046821, 639707048019, 639707048614, 639707049824, 639707054312, 639707054703, 639707056603, 639707057103, 639707059010, 639707059803, 639707060503, 639707060620, 639707063008, 639707064215, 639707067207, 639707068107, 639707069307, 639707071907, 639707073107, 639707084404, 639707084607, 639707087705, 639707091106, 639707091605, 639707091904, 639707092605, 639707092804, 639707093704, 639707095905, 639707098105, 639707099806, 639707106206, 639707108605, 639707115406, 639805000005, 639807006866, 639807010230, 639807012628, 639807026026, 639807033926, 639807044417, 639807045513, 639807046624, 639807046714, 639807048316, 639807054312, 639807054910, 639807056603, 639807063020, 639807063408, 639807064108, 639807079007, 639807084404, 639807090805, 639807091306, 639807094006, 639807095106, 639807097404, 639807097905, 639807105206, 639807108705, 639907026026, 639907039618, 639907042813, 639907046814, 639907062608, 639907063615, 639907063808, 639907090304, 639907093304, 639907105506, 639907110605, 639907111006, 640105000106, 640107002133, 640107005465, 640107008862, 640107009360, 640107010030, 640107010230, 640107012628, 640107012630, 640107013928, 640107017328, 640107019628, 640107026626, 640107033102, 640107033602, 640107034026, 640107034223, 640107037226, 640107038518, 640107039222, 640107040618, 640107041517, 640107042613, 640107042813, 640107043813, 640107044117, 640107044517, 640107045121, 640107045513, 640107046919, 640107047614, 640107048316, 640107049824, 640107050924, 640107054509, 640107054510, 640107054610, 640107054703, 640107054809, 640107055203, 640107056603, 640107057103, 640107058108, 640107058511, 640107059811, 640107060203, 640107060620, 640107062003, 640107063020, 640107063408, 640107064108, 640107079007, 640107083104, 640107088406, 640107090004, 640107090304, 640107091904, 640107092006, 640107092605, 640107096206, 640107097404, 640107099505, 640107102706, 640107107206, 640107109405, 641805000172, 641805000252, 641805000455, 641805000555, 641805000564, 641805000568, 641805000660, 641805000765, 641805000856, 641805000862, 641805000956, 641805000957, 641805001157, 641805001258, 641807002969, 641807005165, 641807005465, 641807005859, 641807006053, 641807006068, 641807006763, 641807006866, 641807006955, 641807007664, 641807007766, 641807007861, 641807007866, 641807007964, 641807008052, 641807009162, 641807009660, 641807009962, 641807010758, 641807011158
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coopervision Inc., Fairport, NY, by a press release on November 15, 2011, and by letter dated November 16, 2011.  
Manufacturer: Coopervision Manufacturing, Ltd. Hamble, Southhampton. UK. Firm initiated recall is ongoing.
REASON
Presence of silicone oil residue on Avaira Sphere Soft Contact Lenses.
VOLUME OF PRODUCT IN COMMERCE
Nationwide: approx. 3,155,781 lenses; Internationally: estimated 1,722,116 lenses
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
Quick Shield with Snappy Safety Holder, Greiner bio-one. The VACUETTE QUICKSHIELD with SNAPPY Tube Holder is intended to be used only with the VACUETTE Blood Collection Needles and VACUETTE Blood Collection Tubes as a system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions. Item #450254. Recall # Z-0179-2012
CODE
Lot numbers: B041104, B051105 and B071106
RECALLING FIRM/MANUFACTURER
Greiner Bio-One North America, Inc., Monroe, NC, by letter dated August 11, 2011. Firm initiated recall is ongoing.
REASON
Reports of the Vacuette QuickShield Safety Holders breaking during use due to a crack at the holder hub.
VOLUME OF PRODUCT IN COMMERCE
443,950 pieces
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
i-Stat cTnI cartridges Is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Recall # Z-0180-2012
CODE
All lots beginning with letter T. Various lots. List Number 03P90-25; 06F15-03; 06F15-04; 600-9009-25; LOT List Number EXP. DATE T11059 03P90-25 28-Sep-11 T11059A 03P90-25 28-Sep-11 T11059B 03P90-25 28-Sep-11 T11060 03P90-25 28-Sep-11 T11060A 03P90-25 28-Sep-11 T11060B 03P90-25 28-Sep-11 T11061 03P90-25 28-Sep-11 T11061A 03P90-25 28-Sep-11 T11061C 03P90-25 28-Sep-11 T11062A 03P90-25 28-Sep-11 T11062B 03P90-25 28-Sep-11 T11063 03P90-25 28-Sep-11 T11063A 03P90-25 28-Sep-11 T11064 03P90-25 28-Sep-11 T11065 03P90-25 28-Sep-11 T11066 03P90-25 28-Sep-11 T11067 03P90-25 28-Sep-11 T11068 06F15-03 28-Sep-11 T11068A 03P90-25 28-Sep-11 T11068B 03P90-25 28-Sep-11 T11069 06F15-03 28-Sep-11 T11069A 03P90-25 28-Sep-11 T11069B 03P90-25 28-Sep-11 T11070 03P90-25 28-Sep-11 T11070A 03P90-25 28-Sep-11 T11070B 03P90-25 28-Sep-11 T11070C 03P90-25 28-Sep-11 T11070D 03P90-25 28-Sep-11 T11072 03P90-25 28-Sep-11 T11072A 03P90-25 28-Sep-11 T11073 06F15-03 28-Sep-11 T11073A 03P90-25 28-Sep-11 T11073B 03P90-25 28-Sep-11 T11074 03P90-25 14-Oct-11 T11074A 03P90-25 14-Oct-11 T11075 03P90-25 14-Oct-11 T11075A 03P90-25 14-Oct-11 T11075B 03P90-25 14-Oct-11 T11076 06F15-03 14-Oct-11 T11076A 03P90-25 14-Oct-11 T11076B 03P90-25 14-Oct-11 T11077 03P90-25 14-Oct-11 T11077A 03P90-25 14-Oct-11 T11078 03P90-25 14-Oct-11 T11079 03P90-25 14-Oct-11 T11079A 03P90-25 14-Oct-11 T11080 06F15-03 14-Oct-11 T11081 03P90-25 14-Oct-11 T11081A 03P90-25 14-Oct-11 T11081B 06F15-03 14-Oct-11 T11082 03P90-25 14-Oct-11 T11083 03P90-25 14-Oct-11 T11083A 03P90-25 14-Oct-11 T11083B 03P90-25 14-Oct-11 T11084 03P90-25 14-Oct-11 T11084A 03P90-25 14-Oct-11 T11087 03P90-25 14-Oct-11 T11088 03P90-25 28-Oct-11 T11088A 03P90-25 28-Oct-11 T11089A 03P90-25 28-Oct-11 T11089B 03P90-25 28-Oct-11 T11090 03P90-25 28-Oct-11 T11091 03P90-25 28-Oct-11 T11091A 03P90-25 28-Oct-11 T11091B 03P90-25 28-Oct-11 T11092 03P90-25 28-Oct-11 T11095 03P90-25 28-Oct-11 T11095A 03P90-25 28-Oct-11 T11096 03P90-25 28-Oct-11 T11096C 03P90-25 28-Oct-11 T11096D 03P90-25 28-Oct-11 T11097 03P90-25 28-Oct-11 T11097B 03P90-25 28-Oct-11 T11098 03P90-25 28-Oct-11 T11099 03P90-25 28-Oct-11 T11099A 03P90-25 28-Oct-11 T11100 03P90-25 28-Oct-11 T11101 03P90-25 28-Oct-11 T11101A 03P90-25 28-Oct-11 T11102 03P90-25 28-Oct-11 T11102A 03P90-25 28-Oct-11 T11102B 03P90-25 28-Oct-11 T11103 03P90-25 28-Oct-11 T11103A 03P90-25 28-Oct-11 T11104A 03P90-25 28-Oct-11 T11104B 06F15-03 28-Oct-11 T11105 06F15-03 14-Nov-11 T11105A 06F15-03 14-Nov-11 T11105B 06F15-03 14-Nov-11 T11107 03P90-25 14-Nov-11 T11107A 03P90-25 14-Nov-11 T11108 03P90-25 14-Nov-11 T11108A 03P90-25 14-Nov-11 T11108B 03P90-25 14-Nov-11 T11109 06F15-03 14-Nov-11 T11109B 06F15-03 14-Nov-11 T11110 03P90-25 14-Nov-11 T11110A 03P90-25 14-Nov-11 T11110B 03P90-25 14-Nov-11 T11110C 03P90-25 14-Nov-11 T11111 03P90-25 14-Nov-11 T11111A 03P90-25 14-Nov-11 T11112A 03p90-25 14-Nov-11 T11112B 03P90-25 14-Nov-11 T11113 03P90-25 14-Nov-11 T11113A 03P90-25 14-Nov-11 T11114 03P90-25 14-Nov-11 T11114A 03p90-25 14-Nov-11 T11115 03P90-25 14-Nov-11 T11115A 03P90-25 14-Nov-11 T11116 03P90-25 14-Nov-11 T11116A 06F15-03 14-Nov-11 T11117 03P90-25 14-Nov-11 T11118 03P90-25 14-Nov-11 T11118A 03P90-25 14-Nov-11 T11118B 03P90-25 14-Nov-11 T11118C 03P90-25 14-Nov-11 T11119 03P90-25 28-Nov-11 T11120 03P90-25 28-Nov-11 T11120A 03P90-25 28-Nov-11 T11121 03P90-25 28-Nov-11 T11121A 06F15-03 28-Nov-11 T11122 06f15-03 28-Nov-11 T11123 03P90-25 28-Nov-11 T11123B 03P90-25 28-Nov-11 T11123C 03P90-25 28-Nov-11 T11124 03P90-25 28-Nov-11 T11124A 03P90-25 28-Nov-11 T11124B 03P90-25 28-Nov-11 T11125 03P90-25 28-Nov-11 T11125A 03P90-25 28-Nov-11 T11125C 03P90-25 28-Nov-11 T11126 03P90-25 28-Nov-11 T11127 03P90-25 28-Nov-11 T11127A 03P90-25 28-Nov-11 T11128 03P90-25 28-Nov-11 T11128B 03P90-25 28-Nov-11 T11129A 03P90-25 28-Nov-11 T11129B 03P90-25 28-Nov-11 T11131A 03P90-25 28-Nov-11 T11132 03P90-25 28-Nov-11 T11132A 03P90-25 28-Nov-11 T11132B 03P90-25 28-Nov-11 T11133 03P90-25 28-Nov-11 T11136 03P90-25 14-Dec-11 T11136A 03P90-25 14-Dec-11 T11137 03P90-25 14-Dec-11 T11137A 03P90-25 14-Dec-11 T11137B 03P90-25 14-Dec-11 T11138 06F15-03 14-Dec-11 T11138A 06F15-03 14-Dec-11 T11138B 06F15-03 14-Dec-11 T11139 03P90-25 14-Dec-11 T11139A 03P90-25 14-Dec-11 T11139B 03P90-25 14-Dec-11 T11140 03P90-25 14-Dec-11 T11142 03P90-25 14-Dec-11 T11143 03P90-25 14-Dec-11 T11143A 03P90-25 14-Dec-11 T11144 03P90-25 14-Dec-11 T11144A 03P90-25 14-Dec-11 T11145A 03P90-25 14-Dec-11 T11147 03P90-25 14-Dec-11 T11147A 03P90-25 14-Dec-11 T11149 03P90-25 28-Dec-11 T11150 03P90-25 28-Dec-11 T11150A 03P90-25 28-Dec-11 T11151 03P90-25 28-Dec-11 T11151A 03P90-25 28-Dec-11 T11151B 03P90-25 28-Dec-11 T11153 03P90-25 28-Dec-11 T11153A 03P90-25 28-Dec-11 T11153B 03P90-25 28-Dec-11 T11154 06F15-03 28-Dec-11 T11156 06F15-03 28-Dec-11 T11156A 03P90-25 28-Dec-11 T11157 03P90-25 28-Dec-11 T11158 03P90-25 28-Dec-11 T11158B 03P90-25 28-Dec-11 T11159 03P90-25 28-Dec-11 T11160 03P90-25 28-Dec-11 T11163A 03P90-25 28-Dec-11 T11164 03P90-25 28-Dec-11 T11165C 03P90-25 28-Dec-11 T11166 03P90-25 14-Jan-11 T11167 06F15-03 14-Jan-11 T11172 03P90-25 14-Jan-11 T11172A 03P90-25 14-Jan-11 T11173 03P90-25 14-Jan-11 T11174 03P90-25 14-Jan-11 T11174B 03P90-25 14-Jan-11 T11175 06F15-03 14-Jan-11 T11177 03P90-25 14-Jan-11 T11186 03P90-25 28-Jan-11 T11202 06F15-03 28-Jan-11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Point Of Care Inc., Princeton, NJ, by letter dated September 2011. 
Manufacturer: Abbott Point of Care, Nepean Ontario, Canada. Firm initiated recall is ongoing.
REASON
i-Stat cTnI cartridges beginning with letter "T" may exhibit a higher than expected variability in reported results. This increased variability may result in falsely elevated or falsely depressed results.
VOLUME OF PRODUCT IN COMMERCE
310 lots - 2,758,900 cartridges
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX Cardiovascular suite is a cardiovascular Information system providing image archiving and image display and modality study-specific structured reporting. Recall # Z-0212-2012
CODE
Software Versions - All DICOMStore Version 2.04.44 and earlier.
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter dated May 27, 2011.  
Manufacturer: AGFA HealthCare Corp., Westerly, RI. Firm initiated recall is ongoing.
REASON
Incorrect entries in mapping files could lead to inaccurate measurement display in adult and pediatric echo reports when using the IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR).
VOLUME OF PRODUCT IN COMMERCE
280 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
IMPAX CardioVascular (CV) Admin Tool The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. Recall # Z-0272-2012
CODE
Software Versions 1.00.26, 1.00.27, CV7.4.SU3 and CV7.8.
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter on June 6, 2011.
Manufacturer: AGFA HealthCare Corp., Westerly, RI. FDA initiated recall is ongoing.
REASON
Potential for misattribution of data and for a report to become unavailable when the user requests for it to be moved to another study that already has a report associated with it.
VOLUME OF PRODUCT IN COMMERCE
323 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8001; Individually Packaged Kit. The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing. Recall # Z-0286-2012;
 
2) ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8013, Provider Pack: 10 test (with lancet). The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing. Recall # Z-0287-2012;
 
3) ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8014, Provider Pack: 10 test (without lancet). The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing. Recall # Z-0288-2012;
 
4) ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8015, Screening Pack: 50 test (with lancet). The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing. Recall # Z-0289-2012;
 
5) ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8021, Screening Pack: 100 test (with lancet & capillary). The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing. Recall # Z-0290-2012;
 
6) ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8024, Provider Pack: 5 test. The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing. Recall # Z-0291-2012
CODE
1) Lot Numbers: F0060, F0083, F0094, F0095, F0096, G0005, G0022, G0023, G0026, G0028, G0043, G0044, G0048, G0050, G0056, G0058, H0005, H0007, H0009, H0023, H0047, H0049, H0052, I0002, I0104, I0112, I0115;
 
2) Lot Numbers: F0023, G0016, G0020, G0041, G0046, G0052, G0055, H008, H0011, H0036, H0044, H0053, I0043;
 
3) Lot Numbers: F0024, G0006, G0042, G0047, G0054, H0046;
 
4) Lot Number: G0040;
 
5) Lot Number: G0027;
 
6) Lot Numbers: G0013, G0053, G0057, H0030, H0048, H0058
RECALLING FIRM/MANUFACTURER
Recalling Firm: ImmuneTech, Inc., Foster City, CA, by letter dated November 4, 2011.
Manufacturer: H & P Industries, Inc., Hartland, WI. Firm initiated recall is ongoing.
REASON
ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial contamination.
VOLUME OF PRODUCT IN COMMERCE
3,340 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave Ports, Convertible Pin, 77 inch , Soluset Microdrip with Option-Lok; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; List 19208-01. Intended use: for the administration of fluids. Recall # Z-0292-2012
CODE
Lot number 83-107-5H
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letter dated November 10, 2011.
Manufacturer: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing.
REASON
The float valve in the burette sticks to the burette wall and does not open or close properly.
VOLUME OF PRODUCT IN COMMERCE
12,580 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Arrow International StimuCath (R) Continuous Nerve Block Kit, ASK-19608-SFH, Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia of analgesia techniques for periods not exceeding 72 hours. Recall # Z-0309-2012
CODE
Lot number: MF0127039
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International Inc., Reading, PA, by letter dated June 20, 2011.
Manufacturer: Arrow International Inc., Asheboro, NC. Firm initiated recall is ongoing.
REASON
Some of the outer trays used in the packaging were found to have an insufficient seal. Therefore, the packaging may have been compromised, and sterility of the product cannot be guaranteed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Philips Digital Diagnost Rel 3, a radiographic system, digital Intended use: Radiographic system, digital. Recall # Z-0313-2012
CODE
S/N: SN11000009 SN11000012 SN11000014 SN11000015 SN11000016 SN11000017 SN11000025 SN11000029 SN11000013 SN11000020 SN11000022 SN11000005 SN11000008 SN11000010 SN11000003 SN11000019 SN11000034 SN11000004 SN11000018 SN11000023 SN11000024 SN11000006 SN11000007 SN11000011 SN11000026 SN11000027 SN11000028 SN11000002
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter dated October 25, 2011.
Manufacturer: Philips Medical Systems Gmbh, DMC, Development and Manufacturing Ctr., Hamburg, Germany. Firm initiated recall is ongoing.
REASON
Missing a small, metal protective cover on the bottom side of the control handle for the ceiling suspension, exposes printed circuit.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Primary Hip Prosthesis Femoral Stem SIZE 16 171 MM STEM LENGTH 12/14 NECK TAPER - STANDARD BODY - STANDARD NECK OFFSET TIVANIUM TI-6AL-4V ALLOY/TANTALUM STERILE. Item number: 00-7864-016-00. Recall # Z-0366-2012;
 
2) Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Hip Prosthesis Femoral Stems: FEMORAL BODY REVISION NITRIDED POROUS 12/14 NECK TAPER EXTENDED 46 MM NECK OFFSET SPOUT BODY SIZE E 55 MM BUILD-UP TIVANIUM TI-6AL-4V ALLOY STERILE. Item number: 00-9991-021-55. Recall # Z-0367-2012;
 
3) Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Hip Prosthesis Femoral Stems: FEMORAL BODY REVISION NITRIDED POROUS 12/14 NECK TAPER STANDARD 40 MM NECK OFFSET CONE BODY SIZE C 35 MM BUILD-UP TIVANIUM TI-6AL-4V ALLOY STERILE. Item number: 00-9996-019-35. Recall # Z-0368-2012
CODE
1) Lot number: 00104820;
2) Lot number: 00104623;
3) Lot number: 00104621
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by letters on November 16, 2011. Firm initiated recall is ongoing.
REASON
Lack of assurance of proper metal fatigue strength due to metal grain structure anomaly. In 2006 a recall was initiated as a result of the grain anomaly; however, these lots had been split off during normal production and had not been included in the 2006 recall.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Nationwide, Australia, Switzerland and Denmark
___________________________________
PRODUCT
Philips Multi Diagnost Eleva with Flat Software R5.2.2. Philips MultiDiagnost Eleva system is intended to be Intended used as a multifunctional/Universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Urinary system, Reproductive system, Respiratory system, Circulatory system, and various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography. Recall # Z-0371-201
CODE
Serial Numbers: 1 2 4 11 42 43 31 44 48 35 99 127 128 154 163 171 150 183 172 156 200 199 194 238 245 212 248
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter dated November 14, 2011.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
Displayed Dose Area Product (DAP) is displayed by a factor 100 too low.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
Nationwide, Denmark, France, Netherlands, Norway, Sweden, and Switzerland
___________________________________
PRODUCT
Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe, Part Number: 39622, Catalog #491B. TA disposable temperature probe used in conjunction with a measuring/monitoring device to continuously measure/monitor a patient's core body temperature. Recall # Z-0372-2012
CODE
Lots: 12998, 12999, 19257, 19257A, 19644, 21536, 21537, 27446, 29112, 31081, 31082, 32209, 37281, 38522, 8996, D414723, D416607, D420120, D421702, D423801, D423908, D525212, D515408, D516607, D517108, D520709, D524107, D525502, D527632, D530518, D624011, D624012, D634834, D706611, D709119, D720450, D721118, D722015, and D727416
RECALLING FIRM/MANUFACTURER
Cincinnati Sub-Zero Products Inc., Cincinnati, OH, by letter on November 1, 2011. Firm initiated recall is ongoing.
REASON
Reports that the Rectal/ Esophageal Temperature Probes are not reading correctly. This situation causes the Blanketrol device, which the probes connect to, to shut down operation and display a 'check probe' error.
VOLUME OF PRODUCT IN COMMERCE
369,680
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY. Hip and knee joint replacement prostheses intended for primary and revision joint arthroplasty for use in cemented applications. Item: 150368. Recall # Z-0417-2012
CODE
Lot 081650
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated November 1, 2011. Firm initiated recall is on going.
REASON
Biomet has initiated this action following an investigation which identified that Part 150367, (OSS Cemented 1M Stem 13x150) was incorrectly labeled as part 150368 (OSS Cemented 1M Stem 14x150).
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
The Netherlands
___________________________________
PRODUCT
1) Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy. PM2110, 2112, 2210, 2212 (Accent DR). Recall # Z-0429-2012;
 
2) Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy. Models PM3110, 3112, 3210,3212 (Anthem). Recall # Z-0430-2012
CODE
All lots and serial numbers
RECALLING FIRM/MANUFACTURER
St Jude Medical CRMD, Sylmar, CA, by letter dated September 22, 2011. Firm initiated recall is ongoing. 
REASON
St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements. These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are concluded as false.
VOLUME OF PRODUCT IN COMMERCE
166,000 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT** STERILE***ENDOTEC***” SIZE 1 x 0mm CAT 04-33-0001; SIZE 2 x 0mm CAT 04-33-0002; SIZE 3 x 0mm CAT 04-33-0003; SIZE 4 x 0mm CAT 04-33-0004; SIZE 5 x 0mm CAT 04-33-0005; SIZE 6 x 0mm CAT 04-33-0006. Tricompartmental Knee Replacement. Recall # Z-0431-2012
 
2) "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT** STERILE***ENDOTEC***" SIZE 1 x 2.5mm CAT 04-33-0011; SIZE 2 x 2.5mm CAT 04-33-0012; SIZE 3 x 2.5mm CAT 04-33-0013; SIZE 4 x 2.5mm CAT 04-33-0014; SIZE 5 x 2.5mm CAT 04-33-0015; SIZE 6 x 2.5mm CAT 04-33-0016. Tricompartmental Knee Replacement. Recall # Z-0432-2012;
 
3) "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT*** STERILE***ENDOTEC***" SIZE 1 x 5mm CAT 04-33-0021; SIZE 2 x 5mm CAT 04-33-0022; SIZE 3 x 5mm CAT 04-33-0023; SIZE 4 x 5mm CAT 04-33-0024; SIZE 5 x 5mm CAT 04-33-0025; SIZE 6 x 5mm CAT 04-33-0026. Tricompartmental Knee Replacement. Recall # Z-0433-2012;
 
4) "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT*** STERILE***ENDOTEC***" SIZE 1 x 7.5mm CAT 04-33-0031; SIZE 2 x 7.5mm CAT 04-33-0032; SIZE 3 x 7.5mm CAT 04-33-0033; SIZE 4 x 7.5mm CAT 04-33-0034; SIZE 5 x 7.5mm CAT 04-33-0035; SIZE 6 x 7.5mm CAT 04-33-0036. Tricompartmental Knee Replacement. Recall # Z-0434-2012
 
5) "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT*** STERILE***ENDOTEC***" SIZE 1 x 10mm CAT 04-33-0041; SIZE 2 x 10mm CAT 04-33-0042; SIZE 3 x 10mm CAT 04-33-0043; SIZE 4 x 10mm CAT 04-33-0044; SIZE 5 x 10mm CAT 04-33-0045; SIZE 6 x 10mm CAT 04-33-0046. Tricompartmental Knee Replacement. Recall # Z-0435-2012;
 
6) "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***CAT.NO.***SIZE***" SIZE 3-3X0 CAT 04-63-2103; SIZE 3-4X0 CAT 04-632104; SIZE 3-5X0 CAT 04-63-2105; SIZE 3-6X0 CAT 04-63-2106. Tricompartmental Knee Replacement. Recall # Z-0436-2012;
 
7) "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***CAT.NO.***SIZE***" SIZE 3-3X2.5 CAT 04-63-2113; SIZE 3-4X2.5 CAT 04-63-2114; SIZE 3-5X2.5 CAT 04-63-2115; SIZE 3-6X2.5 CAT 04-63-2116. Tricompartmental Knee Replacement. Recall # Z-0437-2012;
 
8) "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC** CAT.NO.***SIZE***" SIZE 3-3X5 CAT 04-63-2123; SIZE 3-4X5 CAT 04-63-2124; SIZE 3-5X5 CAT 04-63-2125; SIZE 3-6X5 CAT 04-63-2126. Tricompartmental Knee Replacement. Recall # Z-0438-2012;
 
9) "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***CAT. NO***SIZE***" SIZE 3-3X7.5 CAT 04-63-2133; SIZE 3-4X7.5 CAT 04-63-2134; SIZE 3-5X7.5 CAT 04-63-2135; SIZE 3-6X7.5 CAT 04-63-2136. Tricompartmental Knee Replacement. Recall # Z-0439-2012;
 
10) "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***" Cat #: 04-33-1002 Modular Tibial Bearing 2 X 0 Cat #: 04-33-1003 Modular Tibial Bearing 3 X 0 Cat #: 04-33-1004 Modular Tibial Bearing 4 X 0 Cat #: 04-33-1005 Modular Tibial Bearing 5 X 0 Cat #: 04-33-1006 Modular Tibial Bearing 6 X 0. Tricompartmental Knee Replacement. Recall # Z-0440-2012;
 
11) "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC*** " Size: 04-33-1012 Modular Tibial Bearing 2 X 2.5 04-33-1013 Modular Tibial Bearing 3 X 2.5 04-33-1014 Modular Tibial Bearing 4 X 2.5 04-33-1015 Modular Tibial Bearing 5 X 2.5 04-33-1016 Modular Tibial Bearing 6 X 2.5. Tricompartmental Knee Replacement. Recall # Z-0441-2012;
 
12) "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***" Size: 04-33-1022 Modular Tibial Bearing 2 x 5 04-33-1023 Modular Tibial Bearing 3 X 5 04-33-1024 Modular Tibial Bearing 4 X 5 04-33-1025 Modular Tibial Bearing 5 X 5 04-33-1026 Modular Tibial Bearing 6 X 5. Tricompartmental Knee Replacement. Recall # Z-0442-2012;
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
13) "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***." Size: 04-33-1032 Modular Tibial Bearing 2 X 7.5 04-33-1033 Modular Tibial Bearing 3 X 7.5 04-33-1034 Modular Tibial Bearing 4 X 7.5 04-33-1035 Modular Tibial Bearing 5 X 7.5 04-33-1036 Modular Tibial Bearing 6 X 7.5. Tricompartmental Knee Replacement. Recall # Z-0443-2012
CODE
1) LOT #'S: 04330001Z001NN435 04330001Z005NN436 K04330002A1NN459 K04330002A2NN712 04330003ONN700 04330004NNN462 K04330004B1NN702 04330005Z001NN435 04330005NNN459 K04330005AANN733 04330005AANN736 04330005ABNN751 04330006Z001NN437 04330006H1NN749;
 
2) LOT #'S: 04330011Z001NN436 K04330012A1NN712 K04330012A3NN720 04330012Z002NN443 K04330013A3NN720 K04330013A5NN750 04330014A1NN462 K04330014A1NN726 K04330014A2NN750 04330015Z005NN436 04330015Z001NN726 K04330015Z001-1NN453 04330015AANN752 04330016HNN749;
 
3) LOT #'S: K04330021A1NN703 K04330021Z002NN439 K04330022A1NN720 04330022Z1001NN439 K04330022A2NN750 K04330023A1NN720 04330023M2NN751 K04330024A1NN703 04330025AANN755 04330026HNN339 04330026FNN309 04330026HNN400;
 
4) LOT #'S: 04330031Z001NN434 K04330031A1NN701 K04330031A2NN702 K04330032A1NN720 04330032Z001NN444 K04330032Z1001NN453 K04330033A1NN720 K04330033Z001NN450 K04330034A1NN703 04330034Z001NN442 04330035HNN398 04330035JNN398 04330036HNN338 04330036GNN321 04330036FNN309 04330036GNN400 04330036HNN400;
 
5) LOT #'S: K04330041A1NN467 K04330041A2NN741 K04330042A1NN467 K04330042A2NN467 K04330042A3NN741 K04330043A1NN467 K04330043A2NN467 K04330043A3NN741 K04330044A1NN467 K04330044A2NN741 K04330045A1NN742 K04330046A1NN742;
 
6) LOT #'S: 04632103ANN172 04632103BNN201 04632103CNN211 04632103DNN249 04632103DNN261 04632104BNN201 04632104DNN249 04632104DNN261 04632105ANN193 04632105BNN201 04632105DNN249 04632106BNN257;
 
7) LOT #'S: 04632113ANN172 04632114BNN249 04632114BNN261 04632115BNN249 04632115BNN261 04632116ANN172;
 
8) LOT #'S: 04632123ANN172, 04632124BNN249, 04632125BNN249, 04632126ANN172;
 
9) LOT #'S 04632133ANN172, 04632134BNN249, 04632135BNN249, 04632136ANN172;
 
10) LOT #'s: 04331002ANN286, 04331003ANN286, 04331004ANN286, 04331005ANN286, 04331006ANN286;
 
11) LOT #'s: 04331012ANN286, 04331013ANN286, 04331014ANN286, 04331015ANN286, 04331016ANN286;
 
12) LOT #'s: 04331022ANN286, 04331023ANN286, 04331024ANN286, 04331025ANN286, 04331026ANN286;
 
13) LOT #'s: 04331032ANN286, 04331033ANN286, 04331034ANN286, 04331035ANN286, 04331036ANN286
RECALLING FIRM/MANUFACTURER
Endotec, Inc., Orlando, FL, by letter dated September 21, 2011. FDA initiated recall is ongoing.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
REASON
The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components
VOLUME OF PRODUCT IN COMMERCE
2,400 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh. Recall # Z-0446-2012
CODE
Serial number LP-07-000695-714, lot number P0009032007-NW-05, expiry date Jul-12; Serial number TT-07-002201-2500, lot number P0009032007-NW-05, expiry date Sep-12; and Serial number PL-09-000006 to 15, lot number P0010112007-NW-05, expiry date Dec-12,
RECALLING FIRM/MANUFACTURER
Osteopore International PTE LTD, Singapore, Singapore, by letter dated April 27, 2011. Firm initiated recall is ongoing.
REASON
Product sterility may be compromised.
VOLUME OF PRODUCT IN COMMERCE
330 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Walgreens Quick Read Digital Thermometer; an electronic digital thermometer; Model WIC551226, UPC 31191708790. Recall # Z-0506-2012
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Walgreen Co., Deerfield, IL, by e-mail on November 23, 2011.
Manufacturer: Dongguan Dalang Vigor Electronics Mfy., Dongguan City, Guangdong  
China. FDA Initiated recall is ongoing
REASON
The thermometers have been reported to have inaccurate readings.
VOLUME OF PRODUCT IN COMMERCE
estimated 92,000 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS III
___________________________________
PRODUCT
Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10. Recall # Z-0453-2012
CODE
Lots affected: 2803 and 3001
RECALLING FIRM/MANUFACTURER
Cepheid, Sunnyvale, CA, by letters on November 17, 2011. Firm initiated recall is ongoing.
REASON
Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the Xpert MRSA/SA BC (blood culture) product.
VOLUME OF PRODUCT IN COMMERCE
1,289 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS I
___________________________________
PRODUCT
1) Purina Lix 38 Hi-E for Beef Cattle on Forage Diets in 225 lb. tubs. Product bears the firm's product identifier "0061468" on the bottom right of the label on the 225 lb. tub, and the Lot number is stamped on the "Guaranteed Analysis" portion of the product label. Recall # V-016-2012;
 
2) RangeLand 38 Hi-E Tub. Product bears the firm's product identifier "1800033-633" on the bottom right of the label on the 225 lb. tub, and the lot number is stamped on the "Guaranteed Analysis" portion of the product label. Recall # V-017-2012
CODE
1) Lot number "DB00302716" and 2) Lot number "DB00302716"
RECALLING FIRM/MANUFACTURER
Ridley Block Operations, Buffalo, TX, by press release and letter on July, 29, 2011. Firm initiated recall is ongoing.  
REASON
Product is suspected to have excessive levels of urea.
VOLUME OF PRODUCT IN COMMERCE
86,400 lbs (384 225 lb tubs)
DISTRIBUTION
OK, TX
___________________________________
PRODUCT
Purina One Vibrant Maturity 7+ Adult Premium Cat Food, packaged in 3.5- and 7-lb. bags. Recall # V-018-2012
CODE
BEST BY MAY 2012 03341084 and BEST BY MAY 2012 03351084
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nestle Purina PetCare Co., Saint Louis, MO, by press release on July 29, 2011, and e-mails beginning July 29, 2011 and September 1, 2011.
Manufacturer: Nestle Purina PetCare Co., Davenport, IA. FDA initiated recall is ongoing.
REASON
Product contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
30,526 bags
DISTRIBUTION
IA, IL, IN, KY, MI, MN, MO, ND, NE, OH, and WI
 
END OF ENFORCEMENT REPORT FOR DECEMBER 21, 2011
 
#