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U.S. Department of Health and Human Services

Safety

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Enforcement Report for September 14, 2011

 

 
September 14, 2011                                                                                        11-37
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
________________________________________
PRODUCT
1) Whole Spice Organic Sage Crushed; Whole Sage Organic Powder Certified Organic by CCOF. Product sold in 0.32 oz glass jars, product # SAG-OG-1P and 1 lb plastic bags, product # SAG-OG-4B. Recall # F-1675-2011;
 
2) Whole Sage Organic Powder Certified Organic by CCOF. Product sold in 0.80 oz glass jars, and 1 lb plastic bags, product # SAP-OG-4B.Recall # F-1676-2011
CODE
1) and 2) Lot 2101
RECALLING FIRM/MANUFACTURER
Recalling Firm: Whole Spice Inc., Petaluma, CA, by telephone and letter on August 23, 2011.
Manufacturer: American Natural & Organic Spices, Inc., Fremont, CA. FDA initiated recall is complete.
REASON
Firm was notified by their supplier of organic sage that it is being recalled due to the presence of Salmonella.
VOLUME OF PRODUCT IN COMMERCE
51.21 pounds
DISTRIBUTION
PA, WA, CA, FL, WV
________________________________________
PRODUCT
1) Fresh Food Concepts 5 Layer Dip, 16 oz (UPC 35196-44216); 32 oz (UPC 29358-11272); 454 g (UPC 35196-44214). Recall # F-1679-2011;
 
2) Delicioso 5 Layer Dip, 15 oz (UPC 29358-12229); 30 oz (UPC 29358-12230). Recall # F-1680-2011;
 
3) Rojo's Ultimate 7 Layer Dip, 36 oz (UPC 35196-44162). Recall # F-1681-2011;
 
4) Rojo's Supreme 6 Layer Dip, 44 oz (UPC 47502-44180). Recall # F-1682-2011;
 
5) Rojo's 6 Layer Dip, 44 oz (UPC 47502-44185 and UPC 47502-44189). Recall # F-1683-2011;
 
6) Signature Cafe 6 Layer Dip, 15 oz (UPC 21130-06191); 30 oz (UPC 21130-06192); 425 g (UPC 58200-06034); 850 g (UPC 58200-06032). Recall # F-1684-2011
CODE
All containers coded with use-by dates up to and including 09/16/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresh Food Concepts, Inc., Buena Park, CA, by press release and letters on August 12, 2011.
Manufacturers: Fine Mexican Food Products, Inc., Ontario, CA;
Sunshine Export S.A.C, Tambogrande, Peru. FDA initiated recall is ongoing.
REASON
Fresh Food Concepts, Inc. is recalling various Layer Dip products containing guacamole because the avocado has the potential to be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
54,367 cases
DISTRIBUTION
Nationwide and Canada
________________________________________
PRODUCT
Koerner (brand) Nu-Allins Donut Mix, The Beignet French Donut, net wt 50 lbs. Recall # F-1685-2011
CODE
All
RECALLING FIRM/MANUFACTURER
Gulf Coast Blenders, Inc., New Orleans, LA. by telephone and e-mail on August 24, 2011. FDA initiated recall is ongoing.
REASON
Undeclared egg in bulk packaged beignet (doughnut) mix and Milk not listed as source of whey.
VOLUME OF PRODUCT IN COMMERCE
1,870 units
DISTRIBUTION
LA
________________________________________
PRODUCT
Vita Classic Premium Sliced Smoked Atlantic Nova Salmon; frozen or refrigerated cold smoked salmon; net wt. 4 oz (113g). vacuum packed plastic bag, 12 bags per case; Please note: Vita is also recalling the 1st (A) and 3rd (B) shift product as a precautionary measure, but did not include them in their press release. Recall # F-1688-2011
CODE
Sell By DEC 15 2011 01961A, Sell By DEC 15 2011 01961B and Sell By DEC 15 2011 01961C
RECALLING FIRM/MANUFACTURER
Vita Food Products, Inc., Chicago, IL, by press release on August 26, 2011. Florida initiated recall is ongoing.
REASON
The smoked salmon was found to be contaminated with Listeria monocytogenes bacteria.
VOLUME OF PRODUCT IN COMMERCE
8,088 packages
DISTRIBUTION
AL, AK, CA, CO, D.C, FL, GA, ID, IL, IN, KY, MD, MI, NY, OH, OR, PA, SC, TN, VA
________________________________________
PRODUCT
Quaker Chewy Smashbar Graham Pretzel Snack Bar, 8 - 0.84 OZ (24 g) Bars per Net Wt 6.7 OZ (192 g) box, 12 boxes per case; UPC 0 30000 31108 0. Recall # F-1689-2011
CODE
Best Before Dates: OCT 29 11 RB, OCT 30 11 MM, OCT 30 11 RB, NOV 22 11 RB, NOV 23 11 RB, NOV 24 11 RB, NOV 27 11 RB, DEC 22 11 RB, DEC 22 11 MM, DEC 23 11 RB, DEC 23 11 MM, DEC 24 11 RB, DEC 24 11 MM
RECALLING FIRM/MANUFACTURER
Recalling Firm: Quaker Foods and Snacks North America, Chicago, IL, by press release on September 2, 2011.
Manufacturer: Hearthside Food Solutions, LLC, Kentwood, MI. Firm initiated recall is ongoing.
REASON
The Quaker Chewy Smashbar Graham Pretzel snack bars may contain an undeclared milk allergen.
VOLUME OF PRODUCT IN COMMERCE
82,538 cases
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
1) Got Kosher? Turkey Roll on Multigrain (6oz.). Recall # F-1690-2011;
2) 2) Got Kosher? Penne Pesto Pasta 8 oz and 12 oz. Recall # F-1691-2011;
3) Got Kosher? Chicken Salad on Multigrain (7 oz.). Recall # F-1693-2011;
4) Got Kosher? Multigrain Curry Chicken (7 oz.). Recall # F-1694-2011;
5) Got Kosher? Lavash Tuna Salad Wheels (8 oz.). Recall # F-1696-2011;
6) Got Kosher? Lentils & Tofu w/Caramelized Onions (17 oz.). Recall # F-1700-11;
7) Got Kosher? Half Round Pita Tuna. Recall # F-1701-2011;
9) Got Kosher? Turkey on Challah Roll (8 oz). Recall # F-1704-2011;
10) Got Kosher? Tortilla Wrap Tuna Salad (8 oz). Recall # Recall # F-1705-2011;
11) Got Kosher? Tortilla Wrap Grilled Veggies (8 oz). Recall # F-1707-2011;
12) Got Kosher? Non-Dairy Caesar Salad (12 oz). Recall # F-1708-2011;
13) Got Kosher? Tortilla Wrap Tofu Caesar Salad (8 oz). Recall # F-1709-2011;
14) Got Kosher? Small Turkey Sandwich (4 oz). Recall # F-1710-2011;
15) Got Kosher? Multigrain Green Olive Tuna-Low Sodium (7 oz). Recall # F-1711-2011;
16) Got Kosher? Turkey Pastrami Pita Sandwich (6 oz). Recall #F-1712-2011;
17) Got Kosher? Tofu Caesar Wrap (8 oz). Recall # F-1713-2011;
18) Got Kosher? Tofu Curry Wrap (10 oz). Recall # F-1714-2011;
19) Got Kosher? Beef Pastrami on Pretzel (10 oz). Recall # F-1715-2011;
20) Got Kosher? Pretzel Spicy Salami (8 oz). Recall # F-1716-2011;
21) Got Kosher? Salami on Challah Roll (8 oz). Recall # F-1718-2011;
22) Got Kosher? Spicy Salami on Pain Rustique (8 oz). Recall # F-1719-2011;
23) Got Kosher? Tuna Salad on Pain Rustique (10 oz). Recall # F-1720-2011;
24) Got Kosher? Multigrain Salami Roll (7 oz). Recall # F-1722-2011;
25) Got Kosher? Tofu Pesto Wrap (8 oz). Recall # F-1723-2011;
26) Got Kosher? 7-Grain Smoked Turkey Combo (12 oz). Recall #F-1727-2011;
27) Got Kosher? Salami on Corn Combo (12 oz). Recall #F-1728-2011;
28) Got Kosher? Turkey Pastrami on Rye Combo (12 oz). Recall # F-1729-2011;
29) Got Kosher? Tuna Salad on Multigrain (6 oz). Recall # F-1730-2011;
30) Got Kosher? Turkey Pastrami Pita Sandwich (6 oz). Recall # F-1731-2011;
31) Got Kosher? Chinese Tofu Salad (15 oz). Recall # F-1733-2011;
32) Got Kosher? Spicy Tofu Meatballs on Penne Pasta (16 oz). Recall # F-1734-2011
CODE
1) Unit # 657977000337;
2) Units: 657977022414, 657977040081;
3) Units: 657977000032;
4) Units: 657977000035;
5) Unit: 657977000070;
6) Unit: 657977001051;
7) Unit: 657977004007;
8) Unit: Not Available;
9) Unit: Not Available;
10) Unit: 657977000042;
11) Unit: 657977000074;
12) Unit: 657977000078;
13) Unit: 657977004011;
14) Unit: 657977000080;
15) Unit: 657977001303;
16) Unit: 657977000601;
17) Unit: 657977002157;
18) Unit: 657977000801;
19) Unit: 657977000795;
20) Unit: 657977007007;
21) Unit: 657977022100;
22) Unit: 657977000045;
23) Unit: 657977003002;
24) Unit: 657977030037;
25) Unit: 657977000351;
26) Unit: 657977000612;
27) Unit: 657977020014;
28) Unit: 657977020038;
29) Unit: 657977020052;
30) Unit: 657977000030;
31) Unit: 657977002157;
32) Unit: 657977004000;
33) Unit: 657977002242
RECALLING FIRM/MANUFACTURER
Kosher Foods Unlimited, Inc., Los Angeles. CA, by telephone on May 20, 2011. FDA initiated recall is ongoing.
REASON
Undeclared soy and wheat. During a routine inspection at the firm, it was observed that the firm was missing the listing of sub-ingredients from their finished product labels. Within these sub-ingredients are various allergens such as; wheat, soy, and eggs.
VOLUME OF PRODUCT IN COMMERCE
48 units
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
________________________________________
PRODUCT
1) M&P Food Productions brand Classic Cheese Blintzes, Hand made Russian Style, Keep Frozen, net wt. 14 oz. (396g), UPC 7 07163 30325 1 --- The cheese blintzes are packed on a tray (6 blintzes per tray) and placed in a heat-sealed, clear plastic bag with black lettering on a blue background. Recall # F-1677-2011;
 
2) M & P Food Productions brand Classic Cheese & Cherry, Hand made Russian Style, Keep Frozen, net wt. 14 oz. (396g), UPC 7 07163 30327 5. The cheese blintzes are packed on a tray (6 blintzes per tray) and placed in a heat-sealed, clear plastic bag with black lettering on a red background. Recall # F-1678-2011
CODE
Product is uncoded
RECALLING FIRM/MANUFACTURER
M & P Food Productions, Ltd., Brooklyn, NY, by letters dated August 15, 2011. FDA initiated recall is ongoing.
REASON
During an FDA inspection it was discovered that the blintzes contain undeclared wheat. The ingredient statement lists flour. The crepes used in the making of the blintzes are made from wheat flour.
VOLUME OF PRODUCT IN COMMERCE
1,289 packages for both varieties
DISTRIBUTION
NY, NJ, CT, MA, NC, GA, FL, OH, IN, CO
________________________________________
PRODUCT
Mixed nuts with Peanuts; packed in a 4 lb tin with a shelf life of one year; packed 6 tins in a case. Recall # F-1686-2011
CODE
Lot 3650211, 3650311, 3650411, 3650511, 3650611
RECALLING FIRM/MANUFACTURER
Westco Fruit & Nut Co., Inc. T/A Westcott, Irvington, NJ, by Fax on June 15, 2011. Firm initiated recall is ongoing.
REASON
A customer complaint revealed the presence of coconut in a can labeled as mixed nuts.
VOLUME OF PRODUCT IN COMMERCE
7,660 cases
DISTRIBUTION
NJ
________________________________________
PRODUCT
Twin Maple Farm brand Hudson Farm, a Pampered Cow creamery, Washed rind, Semi-soft, made on farm, Aged minimum 60 days, ID# 36-1058. Recall # F-1687-2011
CODE
Batch Code BL2
RECALLING FIRM/MANUFACTURER
Pampered Cow, Ghent, NY, by telephone on August 26, 2011 and letters dated August 29, 2011. FDA initiated recall is ongoing.
REASON
The cheese has the potential to be contaminated with Staphylococcus aureus and E. coli based on FDA sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
27 wheels (approx. 3 lbs. each) & 13 mini wheels (approx. 0.8 lbs. each)
DISTRIBUTION
NY, VT, IL, VA
­­­­­­________________________
PRODUCT
1) Got Kosher? Small Vegertarian Burrito (5 oz.) and (8 oz.), Recall #F-1692-2011;
2) Got Kosher? Multi Half &Half Tuna Egg (6 oz.). Recall # F-1695-2011;
3) Got Kosher? Lavash Egg Salad Wheels (8 oz.). Recall # F-1697-2011;
4) Got Kosher? Penne Pasta (12 oz.). Recall # F-1698-2011;
5) Got Kosher? Falafel Burrito (10 oz.). Recall # F-1699-2011;
6) Got Kosher? Multigrain Egg Salad (8 oz). Recall #F-1702-2011;
7) Got Kosher? Tortilla Wrap Egg Salad (8 oz). Recall # F-1706-2011;
8) Got Kosher? Grilled Vegetables on Baguette (9 oz). Recall # F-1717-2011;
9) Got Kosher? Half Round Pita Egg (4 oz). Recall # F-1721-2011;
10) Got Kosher? Green Salad Tuna & Egg (10 oz). Recall # F-1724-2011;
11) Got Kosher? Rotello Pasta with Tuna & Egg (10 oz). Recall #F-1725-2011;
12) Got Kosher? Falafel Combo (10 oz). Recall #F-1726-2011;
13) Got Kosher? Egg Salad on Challah Roll (8 oz). Recall # F-1732-2011;
CODES
1) Units: 657977000135, 657977001426;
2) Unit: 657977000375;
3) Unit: 657977000071;
4) Unit: 657977001051
5) Unit: 657977001440;
6) Unit: 657977000313;
7) Unit: 657977000075;
8) Unit: 657977030068;
9) Unit: 657977000207;
10) Unit: 657977001037;
11) Unit: 65797701042;
12) Unit: 65797701042;
13) Unit: 657977000041;
RECALLING FIRM/MANUFACTURER
Kosher Foods Unlimited, Inc., Los Angeles. CA, by telephone on May 20, 2011. FDA initiated recall is ongoing.
REASON
Undeclared soy and wheat. During a routine inspection at the firm, it was observed that the firm was missing the listing of sub-ingredients from their finished product labels. Within these sub-ingredients are various allergens such as; wheat, soy, and eggs.
VOLUME OF PRODUCT IN COMMERCE
48 units
DISTRIBUTION
CA
 
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
________________________________________
PRODUCT
1) Diflorasone Diacetate Ointment USP, 0.05%, Fougera label, 30 gram tube, Rx only, NDC 0168-0243-30
2) ApexiCon Ointment (Diflorasone Diacetate Ointment USP, 0.05%), 30 gram tube, PharmaDerm label, Rx only, NDC 0462-0394-30
CODE
1) Batch 428G: Fougera Label,
2) Batch 429G: PharmaDerm Label
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nycomed US, Inc., Melville, New York 11747-0103
Manufacturer: Nycomed US Inc., Hicksville, New York 11801-1126
REASON FOR RECALL
CGMP Deviations: out of specification for viscosity at the 9 month time point.
___________________________________________
PRODUCT
Betamethasone Valerate Ointment USP, 0.1%, 45 gram tube, Rx only, NDC 0168-0033-46
CODE
Batch 600G
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nycomed US Inc., Melville, NY
Manufacturer: Nycomed US Inc., Melville, NY
REASON FOR RECALL
Labeling: lot number and expiration date may be illegible
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II 
________________________________________
PRODUCT
Povidone-Iodine Solution, USP, 10% Topical Solution, sold under the following labels: 1. equaline topical antiseptic solution, 8 fl. oz, (236 mL) per bottle, packaged in 12 bottles per case; NDC 41163-052-55, UPC 0 41163 26752 7; 2. FRED'S first aid antiseptic solution, 8 fl. oz. (236 ml) per bottle, packaged in 2/6s per case; UPC 0 84579 10500 7; 3. GOOD NEIGHBOR PHARMACY povidone iodine, 10% solution, 8 fl. oz. (236 mL) per bottle, packaged in 24 bottles per case, NDC 24385-053-55, UPC 0 87701 90078 5; 4. GOOD SENSE Topical Antiseptic Solution, 8 fl. Oz. (236 mL) per bottle, packaged in 24 bottles per case, UPC 1 80410 00053 8; 5. MEDIC Povidone Iodine, 8 FL OZ (236 mL) per bottle, packaged in 24 bottles per case, NDC 50730-8230-1, UPC 3 21140 79334 9; 6. Meijer Iodine Solution, 8 fl. oz. (236 ml) per bottle, packaged in 12 bottles per case, NDC 41250-677-94, UPC 0 41250 67794 9; 7. Smart sense Povidone-Iodine Solution, 8 fl. oz. (236 mL) per bottle, packaged in 2/6s per case, NDC 49738-050-34, UPC 0 72000 26698 4; 8. Walgreens Apothecary Povidone Iodine, 8 fl. oz. (236 mL) per bottle, packaged in 24 bottles per case, UPC 3 11917 04434 7; 9. Premier Value Povidone-Iodine Antiseptic Solution, 8 fl. oz. (236 mL) bottle, packaged in 24 bottles per case, UPC 8 40986 01294 5; 10. Leader Povidone Iodine Solution, 8 fl. oz. (236 ml) per bottle, packaged in 24 bottles per case, NDC 37205-186-34, UPC 0 96295 10673 2; 11. Major Povidone Iodine Topical Solution, 8 fl. oz. (236 mL) per bottle, packaged in 24 bottles per case, NDC 0904-1103-09, UPC 3 0904-1103-09 2; 12. Laura Lynn Topical Antiseptic Solution, 8 fl. oz. (236 mL) per bottle, packaged in 24 bottles per case, UPC 0 86854 03469 9; 13. AmeriNet Choice Povidone Iodine Prep Solution, a) 16 fl. oz. (473 mL) per bottle, Reorder # AC-8216, packaged in 12 bottles per case; b) 128 fl. oz. (3.785 L) per bottle, NDC 50730-8228-7, Reorder # AC-8228, packaged in 4 bottles per case; 14. Triad Plus Prep Solution, a) 2 fl. oz.  (59 ml) per bottle, NDC 50730 8202-2, Cat. No. 11-LP02, packaged in 48 bottles per case; b) 4 fl. oz. (118 ml) per bottle, NDC 50730-8204-3, Cat. No. 11-LP04, packaged in 48 bottles per case; 15. Select medical products Povidone Iodine, USP Prep Solution, 16 fl. oz. (473 mL) per bottle, packaged in 12 bottles per case, Made in the USA, Reorder #126; 16. PSS Select Povidone Iodine, USP Prep Solution, 1 gallon (3.785 L) per bottle, packaged in 4 bottles per case, Reorder No.: 128; 17. TRIADINE Prep Solution, a) 2 fl. oz. (59 ml) per bottle, NDC 50730-8202-2, Cat. No. 10-8202, packaged in 48 bottles per case; b) 4 fl. oz. (118 ml) per bottle, NDC 50730-8204-3, Cat. No. 10-8204, packaged in 72 bottles per case; c) 8 fl. oz. (236 ml) per bottle, NDC 50730-8208-8, Cat. No. 10-8208, UPC 3 50730 82088 2, packaged in 24 bottles per case; d) 16 fl. oz. (473 ml), NDC 50730-8216-5, Cat. No. 10-8216, UPC 3 50730 82166 7, packaged in 12 bottles per case; e) 32 fl. oz. (946 ml) per bottle, NDC 50730-8232-5, Cat. No. 10-8232, UPC 3 50730 82325 8, packaged in 12 bottles per case; f) 128 fl. oz. (3.785 L) per bottle, NDC 50730-8228-8, Cat. No. 10-8228, UPC 3 50730 82288 6, packaged in 4 bottles per case; 18. TRIADINE Whirlpool Concentrate, 128 fl. oz. (3.785 L) per bottle, packaged in 4 bottles per case; NDC 50730-8428-6, Cat. No. 10-8428, UPC 3 50730 84286 0; 19. NOVAPLUS Povidone-Iodine, USP Prep Solution, a) 2 fl. oz. (59 mL) per bottle, NDC 50730-8202-2, Cat. No. V10-8202, packaged in 48 bottles per case; b) 4 fl. oz. (118 mL) per bottle, NDC 50730-8204-9, Cat. No. V10-8204, UPC 3 50730 82049 3, packaged in 72 bottles per case; c) 8 fl. oz.  (236 mL) per bottle, NDC 50730-8208-9, Cat. No. V10-8208, UPC 3 50730 82089 9, packaged in 24 bottles per case; d) 16 fl. oz. (473 mL) per bottle, NDC 50730-8216-9, Cat. No. V10-8216, UPC 3 50730 82169 0, packaged in 12 bottles per case; e) 32 fl. oz. (946 ml) per bottle, NDC 50730-8232-9, Cat. No. V10-8232, UPC 3 50730 82329 6, packaged in 12 bottles per case; f) 128 fl. oz. (3.79 L) per bottle, NDC 50730-8228-9, Cat. No. V10-8228, UPC 3 50730 82289 3, packaged in 4 bottles per case. Recall # D-909-2011;
 
2) Povidone-Iodine, USP Scrub Solution, 7.5%, sold under the following labels: 1. AmeriNet Choice, a) 16 fl. oz. (473 mL) per bottle, NDC 50730-8316-7, Reorder # AC-8316, packaged in 12 bottles per case; b) 128 fl. oz. (3.785L) per bottle, NDC 50730-8328-7, Reorder # AC-8328, packaged in 4 bottles per case; 2. NOVAPLUS, a) 2 fl. oz. (59mL) per bottle, NDC 50730-8302-1, Cat. No. V10-8302, packaged in 48 bottles per case; b) 4 Fluid Ounces (118 mL) per bottle, NDC 50730-8304-9, Cat. No. V10-8304, UPC 3 50730 83049 2, packaged in 72 bottles per case; c) 8 fl. oz. (236 mL) per bottle, NDC 50730-8308-9, Cat. No. V10-8308, UPC 3 50730 83089 8, packaged in 24 bottles per case; d) 16 fl. oz. (473 mL) per bottle, NDC 50730-8316-9, Cat. No. V10-8316, UPC 3 50730 83169 7, packaged in 12 bottles per case; e) 32 fl. oz. (946 mL) per bottle, NDC 50730-8332-9, Cat. No. V10-8332, UPC 3 50730 83329 5, packaged in 12 bottles per case; f) 128 fl. oz. (3.79L) per bottle, NDC 50730-8328-9, Cat. No. V10-8328, UPC 3 50730 83289 2, packaged in 4 bottles per case; 3. TRIAD, scrub, 8 fl. oz. (236 mL) per bottle, NDC 50730-8308-3, Cat. No. 10-8308, packaged in 24 bottles per case; 4. Triad PLUS, a) 2 fl. oz. (59 ml) per bottle, NDC 50730-8302-1, Cat. No. 11-LS02, packaged in 48 bottles per case; b) 4 fl. oz. (118 ml) per bottle, NDC 50730-8304-2, Cat No. 11-LS04, packaged in 48 bottles per case; 5. TRIADINE, a) 2 fl. oz. (59 ml) per bottle, NDC 50730-8302-1, Cat. No. 10-8302, packaged in 48 bottles per case; b) 4 fl. oz. (118 ml) per bottle, NDC 50730-8304-2, Cat No. 10-8304, packaged in 72 bottles per case; c) 16 fl. oz. (473 ml) per bottle, NDC 50730-8316-4, Cat No. 10-8316, UPC 3 50730 83164 2, packaged in 12 bottles per case; d) 32 fl. oz. (946 ml) per bottle, NDC 50730-8332-5, Cat. No. 10-8332, UPC 3 50730 83325 7, packaged in 12 bottles per case; e) 128 Fluid Ounces (3.785 L) per bottle, NDC 50730-8328-6, Cat No. 10-8328, UPC 3 50730 83286 1, packaged in 4 bottles per case. Recall # D-910-2011;
 
3) Povidone-Iodine Swabstick, Povidone Iodine, USP, 10%, packaged under the following labels: 1. ADOMAL 10% Povidone-Iodine Swabsticks, triple, contains Japanese writing, packaged in 500 pouches per case; 2. AmeriNet Choice Povidone Iodine Prep Swabsticks, a) 1 Swabstick per Pouch, packaged in 50-count Pouches per Box, packaged in 10 boxes per case, Reorder # AC-4101, NDC 50730-4101-7; b) 3 Swabsticks per Pouch, packaged in 25-count Pouches per Box, packaged in 10 boxes per case, Reorder # AC-4102; Made in USA; 3. Allegiance Povidone-Iodine Swab Stick, a) 1 each per pouch, UPC (01) 0 0380470 04716 4, packaged in a 50-count Box, Cat. 40000-040, NDC 63517-410-11, UPC (01) 2 0630140 06395 1; b) 3 Swab Sticks per pack, UPC (01) 0 0380470 14216 6, packaged in 75-count packs per Box, Cat. 40000-050, NDC 63517-410-23, UPC (01) 2 0630140 06396 8; 4. NOVAPLUS Povidone-Iodine Swabstick, a) 1 Swabstick per pouch, packaged in 50-count pouches per box, Cat. No. V9121, NDC 50730-4101-9, packaged in 10 boxes per case; b) 3 Swabsticks per pouch, packaged in 25-count pouches per box, Cat. No. V9123, NDC 50730-4102-9, packaged in 10 boxes per case; Made exclusively for Novation; 5. PSS Select Povidone Iodine, USP Swabstick, a) 1 swabstick per pouch, packaged in 50-count pouches per box, Reorder No: 133, packaged in 10 boxes per case; b) 3 swabsticks per pouch, packaged in 25-count pouches per box, Reorder No 134, packaged in 10 boxes per case; 6. TRIAD Povidone Iodine Swabstick, 1 Swabstick per pouch, packaged in 50-count pouches per box, Cat. No. 10-4101, NDC 50730-4101-1, UPC 3 50730 41011 3, packaged in 10 boxes per case; b) 3 Swabsticks per pouch, packaged in 25-count pouches per box, Cat. No. 10-4102, NDC 50730-4102-3, UPC 3 50730 41023 6, packaged in 10 boxes per case; 7. Triad PLUS Povidone Iodine Swabsticks, a) One Prep, 1 swabstick per pouch, Cat. No. 11-SP01, NDC 50730-4101-8, packaged in 1000 pouches per case; b) Three Prep, 3 swabsticks per pouch, Cat. No. 11-SP03, NDC 50730-4102-8, packaged in 500 pouches per case.  Recall # D-911-2011;
 
4) Povidone Iodine Prep Gel, Povidone-Iodine, USP 10% Topical Gel, Triad PLUS, 4 Fluid Ounces (118 ml) per bottle, packaged in 48 bottles per case, Made In USA; NDC 50730-8214-8, Cat. No. 11- LP14. Recall # D-912-2011;
 
5) Povidone Iodine Scrub Swabstick, Povidone Iodine, USP, 7.5% w/v, a) 1-count swabstick per pouch, packaged in 50-count pouches per box, NDC 50730-4401-1, Cat No. 10-4401, TRIADINE, packaged in 10 boxes per case; b) 3-count swabsticks per pouch, packaged in 25-count pouches per box, NDC 50730-4402-3, Cat. No. 10-4402, UPC 3 50730 44023 3, packaged in 10 boxes per case. Recall # D-913-2011
CODE
All lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C
RECALLING FIRM/MANUFACTURER
H & P Industries, Inc., Hartland, WI, by press release, e-mails and letters dated August 24, 2011. Firm initiated recall is ongoing.
REASON
CGMP Deviations: Products were manufactured without having in place a system for microbial testing at the time of release, without having a system for testing of incoming components, and without having procedures designed and established to prevent objectionable microorganisms in drug products.
VOLUME OF PRODUCT IN COMMERCE
439,005 cases
DISTRIBUTION
Nationwide and Japan
________________________________________
PRODUCT
Xeloda (capecitabine) Tablets, each tablet contains 500 mg, Rx only, bottles of 120, NDC 0004-1101-50. Recall # D-915-2011
CODE
Units: 5HYV, 5HYX, 665B, 67FZ, 65BD, 6BB2, 69DW, 6A2L, 6B7U, 6B7V, 6B81,6D59, 5HZE, 5HZF, 65EJ, 6D5V, 66ZZ, 69YK, 6700, 66G8, 69DN, 65EK, 6D5W, 6D66, 69Y1
RECALLING FIRM/MANUFACTURER
Physicians Total Care, Inc., Tulsa, OK, by fax on March 24, 2011. Firm initiated recall is complete.
REASON
Chemical contamination: The firm was notified by the manufacturing facility that they were recalling the product due to presence of low levels of naphthalene and/or 1,4-dichlorobenzene in the Xeloda 500 mg Tablets causing an off odor.
VOLUME OF PRODUCT IN COMMERCE
34 units
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
Glyburide and Metformin Hydrochloride Tablets 5mg/500mg, 60-count bottle, Rx Only, NDC 54868-5243-00. Recall # D-917-2011
CODE
Lot #: 5695, Exp 07/31/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Physicians Total Care, Inc., Tulsa, OK, by faxed letter on March 1, 2011.
Manufacturer: Teva Pharmaceuticals USA, Inc., Sellersville, PA. Firm initiated recall is complete.
REASON
CGMP Deviations: Re-packaged product was recalled by supplier because lab investigation was not performed in accordance with adherence to the "FDA Guidance For Industry Investigating Out-of-Specification Test Results for Pharmaceutical Production."
VOLUME OF PRODUCT IN COMMERCE
300 bottles
DISTRIBUTION
NC
________________________________________
PRODUCT
Metformin HCl Tablets USP, 850 mg, 100 count bottle, Rx only, NDC # 0093-1049-01. Recall # D-918-2011
CODE
Lot # TE07202, exp 7/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on June 10, 2011.
Manufacturer: Emcure Pharmaceuticals Limited, Maharashtra, India. Firm initiated recall is ongoing.
REASON
Presence of Foreign Substance(s): Some tablets may contain foreign material.
VOLUME OF PRODUCT IN COMMERCE
8,784 bottles
DISTRIBUTION
Nationwide and PR
________________________________________
PRODUCT
1) Thyro-Tab 0.088 mg tablets in bulk drums intended for repackaging, Rx Only. Recall # D-919-2011;
 
2) Levothroid (levothyroxine sodium tablets, USP), 88 mcg, Rx Only, 100-count bottles, NDC 0456-1329-01. Recall # D-920-2011
CODE
1) Lot HA13010, Exp 05/11;
2) Lot 1077362, Exp 05/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lloyd Inc. Of Iowa, Shenandoah, IA, by letters dated April 1, 2011 and April 5, 2011.
Manufacturers: Lloyd Inc., Shenandoah, IA;
Forest Pharmaceuticals Inc., Cincinnati, OH. Firm initiated recall is complete.
REASON
Sub-Potent (Single Ingredient Drug): Stability failure at 9-month testing interval (low). The product may not maintain potency throughout its labeled shelf life.
VOLUME OF PRODUCT IN COMMERCE
1) 1,921,378 tablets; 2) 19,121 bottles
DISTRIBUTION
Nationwide and PR
________________________________________
PRODUCT
Vimovo (naproxen/esomeprazole magnesium), 500 mg/20 mg delayed release tablets, Rx only, a) NDC 0186-0520-60; b) NDC 0186-0520-39; c) NDC 0186-0520-06. Recall # D-921-2011
CODE
a) Lot #s WH0099, exp 2/23/2012; WL0144, exp 2/24/2012; b) Lot # WH0061, exp 2/29/2012; c) Lot #s WJ5003, exp 2/23/2012; WK5000, exp 2/23/2012; WJ5006, exp 3/26/2012; WM5011, exp 4/26/2012.
RECALLING FIRM/MANUFACTURER
Recalling Firm: AstraZeneca Pharmaceuticals LP, Wilmington, DE, by letter on June 28, 2011.
Manufacturer: Patheon Pharmaceuticals Inc., Cincinnati, OH. Firm initiated recall is ongoing.
REASON
Failed Dissolution Specification; naproxen
VOLUME OF PRODUCT IN COMMERCE
497,726
DISTRIBUTION
Nationwide and PR
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
________________________________________
PRODUCT
DESOXIMETASONE CREAM USP 0.25%, a) 15 grams per tube, NDC 0168-0180-15, b) 60 grams per tube, NDC 0168-0180-60, c) 100 grams per tube, NDC 0168-0180-99, Rx only. Recall # D-914-2011
CODE
Lot #: a) 173H, Exp 05/12; b) 175H,178H, Exp 06/12; c) 174H, Exp 05/12; 177H, Exp 06/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nycomed US, Inc., Melville, NY, by letters dated July 7, 2011.
Nycomed Us Inc., Hicksville, NY. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Out of Specification (OOS) results, for a degradantion product were obtained during routine stability testing.
VOLUME OF PRODUCT IN COMMERCE
50,398 tubes
DISTRIBUTION
Nationwide and PR
________________________________________
PRODUCT
DESONIDE OINTMENT, 0.05%, 15 grams per tube, Rx only, NDC 0168-0309-15, UPC 3 0168-0309-15 6. Recall # D-916-2011
CODE
Batch/Lot: 042H, Exp 05/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nycomed US, Inc., Melville, NY, by letters dated May 3, 2011. 
Manufacturer: Nycomed Us Inc., Hicksville, NY. Firm initiated recall is ongoing;
REASON
Container Leakage: Out-of-specification results for weight loss.
VOLUME OF PRODUCT IN COMMERCE
14,926 tubes
DISTRIBUTION
Nationwide and PR
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
________________________________________
PRODUCT
Source Plasma. Recall # B-1892-11
CODE
Units: 06DTXB5923; 06DTXA9435; 06DTXB5713; 06DTXB6447; 06DTXA9100
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services L.P., Deerfield, IL, by facsimile on October 30, 2006. 
Manufacturer: BioLife Plasma Services, L.P., Denton, TX. Firm initiated recall is complete. 
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA
________________________________________
PRODUCT
Source Plasma. Recall # B-1909-11
CODE
Units: 7010391279, 7010383896, 7010382912, 7010382628, 7010381999, 7010381248, 7010380183, 7010379574, 7010379209, 7010378630, 7010377997, 7010377485, 7010377113, 7010366677, 7010363679, 7010363171, 7010362508, 7010362292, 7010361803, 7010356655, 7010355995, 7010355673, 7010354903, 7010349280, 7010343241
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL, by facsimile on October 2, 2007, October 29, 2007 and November 6, 2007.
Manufacturer: Csl Plasma, Inc., Abilene, TX. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
NC, IN
________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1947-11
CODE
Unit: LH76077
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on February 28, 2006. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
________________________________________
PRODUCT
Source Plasma. Recall # B-1954-11
CODE
Units: 09VMNI4163; 09VMNI2879; 09VMNI0694; 09VMNH3915; 09VMNH2631; 09VMNH0560; 09VMNG5985; 09VMNG3505; 09VMNG4719; 09VMNK6428; 09VMNK3330; 09VMNK2149; 09VMNK0162; 09VMNJ8964; 09VMNJ3720; 09VMNJ2432; 09VMNI6801; 09VMNI5479; 08VMNK0746; 08VMNK1595; 08VMNK3616; 08VMNK4649; 08VMNK7793; 08VMNK8871; 08VMNL0850; 08VMNL1727; 08VMNL3837; 08VMNL4784; 08VMNL6616; 08VMNL7483; 08VMNL8569; 09VMNL9630; 09VMNA0575; 09VMNA1574; 09VMNA3580; 09VMNA5496; 09VMNA7463; 09VMNA8559; 09VMNB1627; 09VMNB3638; 09VMNB4802; 09VMNB6898; 09VMNB8127; 09VMNC0252; 09VMNC1478; 09VMNC3627; 09VMNC4866; 09VMNC6948; 09VMNC8229; 09VMND0143; 09VMND1360; 09VMND3452; 09VMND4734; 09VMND6881; 09VMND8192 09VMNE0394; 09VMNE1734; 09VMNE3970; 09VMNE5249; 09VMNE8491; 09VMNF3795; 09VMNF6979; 09VMNF8213; 09VMNG0308; 09VMNG1490; 09VMNF1760; 09VMNB0489
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile on November 4, 2009.
Manufacturer: BioLife Plasma Services L.P., Saint Paul, MN. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
67 units
DISTRIBUTION
CA
________________________________________
PRODUCT
Source Plasma. Recall # B-1955-11
CODE
Units: NA4183;10SMNA3183;10SMNA0630; 09SMNL2686; 09SMNJ5946; 09SMNJ3592; 08SMNJ1428; 08SMNI6161; 08SMNH3695; 08SMNH2608; 08SMNG8276; 08SMNC3125; 08SMNB5991; 08SMNA5165; 08SMNA4462;08SMNJ2727; 09SMNJ9151; 08SMNG7150 07SMNE7242; 07SMNI2103; 07SMNJ6969; 07SMNJ7836; 07SMNK0720; 07SMNK1314; 07SMNA0109; 07SMNA1113; 07SMNA2507; 07SMNA3091; 07SMNF1389; 07SMNF2520; 07SMNF3286; 07SMNF6284; 07SMNF7050; 07SMNF8173
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile on May 14, 2010.
Recalling Firm: BioLife Plasma Services, L.P., Saint Cloud, MN. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported testing positive for Hepatitis B antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
34 units
DISTRIBUTION
CA and Austria
________________________________________
PRODUCT
Source Plasma. Recall # B-1969-11
CODE
Units: 3730055479; 3730056470; 3730056763; 3730057369; 3730057535; 3730058127; 3730058629; 3730059166; 3730059780; 3730060221; 3730060815; 3730061253; 3730062288; 3730063621; 3730063934; 3730064631; 3730065069; 3730065605; 3730065949; 3730066581; 3730066864; 3730067570; 3730068346; 3730069173; 3730069599; 3730070239; 3730070499; 3730071244; 3730071654; 3730072373; 3730072770; 3730073464; 3730073896; 3730074603; 3730074972; 3730075650; 3730076086; 3730076723; 3730077456; 3730077730; 3730078667; 3730078804; 3730079774; 3730080049; 3730080966; 3730081183; 3730082050; 3730082316; 3730083537; 3730084008; 3730084774; 3730085310; 3730085974; 3730086422; 3730087182; 3730087625; 3730088392; 3730088749; 3730089642; 3730090124; 3730091060; 3730091690; 3730092177; 3730092880; 3730093305; 3730094035; 3730094479; 3730095141; 3730095582; 3730096176; 3730096731; 3730097297; 3730097769; 3730098419; 3730099163; 3730099630; 3730100113; 3730100639; 3730101392; 3730101672; 3730102499; 3730102853; 3730104084; 3730058339; 3730058648; 3730059344; 3730059750; 3730060441; 3730060823; 3730061598; 3730061948; 3730062660; 3730063281; 3730063494; 3730064286; 3730066273; 3730066631; 3730067219; 3730067589; 3730068182; 3730068551; 3730069206; 3730069630; 3730070173; 3730070625; 3730071660; 3730072573; 3730072836; 3730073675; 3730074134; 3730074858; 3730075475; 3730076512; 3730077102; 3730077464; 3730079545; 3730080174; 3730080554; 3730082168; 3730082600; 3730083683; 3730084269; 3730084893; 3730085743; 3730086616; 3730087365; 3730088603; 3730089840; 3730091954; 3730092340; 3730094209; 3730094948; 3730095858; 3730096297; 3730096871; 3730097535; 3730097946; 3730098936; 3730099363; 3730100146; 3730101279; 3730103058; 3730103445; 3730060110; 3730060929; 3730061118; 3730061934; 3730062144; 3730062911; 3730063387; 3730063904; 3730064932; 3730065185; 3730065915; 3730066158; 3730066850; 3730067112; 3730067785; 3730068396; 3730068792; 3730069458; 3730069874; 3730070482; 3730070895; 3730071486; 3730071936; 3730072619; 3730073033; 3730080271; 3730080727; 3730081439; 3730081900; 3730082590; 3730083090; 3730083802; 3730084319; 3730085067; 3730085549; 3730086220; 3730086734; 3730087452; 3730087922; 3730088653; 3730089174; 3730089947; 3730090395; 3730091075; 3730091624; 3730092217; 3730092673; 3730093369; 3730093820; 3730094551; 3730094990; 3730095698; 3730096095; 3730096781; 3730097191; 3730097865; 3730098294; 3730099034; 3730099480; 3730100130; 3730101207; 3730102333; 3730102759; 3730103485; 3730103943; 3730104644; 3730105124; 3730105773; 3730106264; 3730106969; 3730107432; 3730065943; 3730066473; 3730066849; 3730067423; 3730067788; 3730068394; 3730068791; 3730069455; 3730069870; 3730070484; 3730070896; 3730071494; 3730071940; 3730072618; 3730073035; 3730073699; 3730074164; 3730075905; 3730076955; 3730079603; 3730080270; 3730080729; 3730081438; 3730081902; 3730082588; 3730083089; 3730083801; 3730084317; 3730085069; 3730085548; 3730086219; 3730086733; 3730087454; 3730087923; 3730088651; 3730089175; 3730089925; 3730092215; 3730092671; 3730095699; 3730096779; 3730097193; 3730097863; 3730098292; 3730099029; 3730099479; 3730100128; 3730100557; 3730101205; 3730101656; 3730106970; 3730107430; 3730072710; 3730074395; 3730075470; 3730075654; 3730076540; 3730076628; 3730077503; 3730077895; 3730078558; 3730079039; 3730079733; 3730080167; 3730080906; 3730081755; 3730082218; 3730082941; 3730083539; 3730084288; 3730084809; 3730085622; 3730086893; 3730087091; 3730088107; 3730088353; 3730089336; 3730089590; 3730090839; 3730091733; 3730091835; 3730092817; 3730093401; 3730093997; 3730094559; 3730095693; 3730096196; 3730097452; 3730098166; 3730098575; 3730099283; 3730099717; 3730100369; 3730100799; 3730101464; 3730101902; 3730102583; 3730102993; 3730103774; 3730104215; 3730104945; 3730105614; 3730106057; 3730106817; 3730107275; 3730107923; 3730074185; 3730075065; 3730075320; 3730076105; 3730076412; 3730077193; 3730077366; 3730078257; 3730078447; 3730079379; 3730079588; 3730080507; 3730080789; 3730081682; 3730081885; 3730082860; 3730083079; 3730084015; 3730084313; 3730085082; 3730085535; 3730086498; 3730086735; 3730087669; 3730087916; 3730088889; 3730089928; 3730090387; 3730091304; 3730091537; 3730092419; 3730092656; 3730093582; 3730093811; 3730094747; 3730094979; 3730095863; 3730096084; 3730096941; 3730097185; 3730098059; 3730098283; 3730099202; 3730099424; 3730100302; 3730100519; 3730101384; 3730102086; 3730102496; 3730103674; 3730106212; 3730107174; 3730107396; 3730082646; 3730083140; 3730083987; 3730084409; 3730085277; 3730085605; 3730086541; 3730087309; 3730087871; 3730089024; 3730089744; 3730103220; 3730103719; 3730104423; 3730104918; 3730090058; 3730090861; 3730091336; 3730091998; 3730092431; 3730093106; 3730093558; 3730094272; 3730094684; 3730096848; 3730097613; 3730098060; 3730098769; 3730099121; 3730100277; 3730101302; 3730101976; 3730102485; 3730103651; 3730104361; 3730104853; 3730105406; 3730105931; 3730106645; 3730107027; 3730107842; 3730083858; 3730084597; 3730085068; 3730085767; 3730086213; 3730087018; 3730087466; 3730088518; 3730089004; 3730091993; 3730093154; 3730095493; 3730096101; 3730096584; 3730097207; 3730097712; 3730098310; 3730098820; 3730099468; 3730100556; 3730101026; 3730101692; 3730102206; 3730102765; 3730103331; 3730103949; 3730104444; 3730105544; 3730106412; 3730106806; 3730107401; 3730086539; 3730087301; 3730087734; 3730088495; 3730088971; 3730089748; 3730090219; 3730092032; 3730092491; 3730093168; 3730093626; 3730094359; 3730094819; 3730095485; 3730095920; 3730096557; 3730097008; 3730097675; 3730098119; 3730098803; 3730099243; 3730099915; 3730100333; 3730101421; 3730102125; 3730102526; 3730103231; 3730103726; 3730104430; 3730104893; 3730105561; 3730106010; 3730106753; 3730107227; 3730107901; 3730086088; 3730086793; 3730088581; 3730089223; 3730089870; 3730094227; 3730097893; 3730098801; 3730099249; 3730101140; 3730106407; 3730106989; 3730107660; 3730075208; 3730075639; 3730076499; 3730076708; 3730077549; 3730077766; 3730079101; 3730079539; 3730080969; 3730081586; 3730082074; 3730082776; 3730083313; 3730084542; 3730085241; 3730085664; 3730086408; 3730087604; 3730088075; 3730088818; 3730089341; 3730090098; 3730090593; 3730091191; 3730092724; 3730093323; 3730094017; 3730094422; 3730095174; 3730095595; 3730096300; 3730097329; 3730097795; 3730098375; 3730098847; 3730100097; 3730100654; 3730101173; 3730101643; 3730102396; 3730102894; 3730103636; 3730103953; 3730104844; 3730105236; 3730105874; 3730106220; 3730107037; 3730107544; 3730067888; 3730068415; 3730068876; 3730069527; 3730069971; 3730070538; 3730070972; 3730071721; 3730072121; 3730072646; 3730073182; 3730073805; 3730074311; 3730074930; 3730075401; 3730075987; 3730076464; 3730077058; 3730077488; 3730078125; 3730078585; 3730079250; 3730079754; 3730080381; 3730080866; 3730081496; 3730082059; 3730082692; 3730083249; 3730083946; 3730084504; 3730085187; 3730085720; 3730086391; 3730086920; 3730087557; 3730088096; 3730088883; 3730089307; 3730090067; 3730090519; 3730091194; 3730091713; 3730093595; 3730093991; 3730094720; 3730095152; 3730095882; 3730096231; 3730096912; 3730097318; 3730098018; 3730098434; 3730099141; 3730099580; 3730100250; 3730100838; 3730101795; 3730102470; 3730102858; 3730103639; 3730104057; 3730104828; 3730105258; 3730105938; 3730106381; 3730107151; 3730107550; 3730068391; 3730069027; 3730090719; 3730094349; 3730096778; 3730097858; 3730098331; 3730102128; 3730102540; 3730103731; 3730106956; 3730077269; 3730077646; 3730078311; 3730102318; 3730103173; 3730104669; 3730105394; 3730105780; 3730106655; 3730107082; 3730107671; 3730076400; 3730076728; 3730077402; 3730079655; 3730080069; 3730081003; 3730081880; 3730092787; 3730100878; 3730105954; 3730106252; 3730088575; 3730088984; 3730089756; 3730103218; 3730103715; 3730104422; 3730104920; 3730070947; 3730071281; 3730072037; 3730072388; 3730073133; 3730073475; 3730074261; 3730074626; 3730075380; 3730075718; 3730076471; 3730076788; 3730077471; 3730077823; 3730078635; 3730078950; 3730079820; 3730080092; 3730080857; 3730081236; 3730081996; 3730082353; 3730083207; 3730083554; 3730084480; 3730084718; 3730085724; 3730086019; 3730086803; 3730087236; 3730088141; 3730088433; 3730089298; 3730089724; 3730090507; 3730090877; 3730091583; 3730091985; 3730092715; 3730093126; 3730093867; 3730094297; 3730095082; 3730095446; 3730096136; 3730096517; 3730097267; 3730097635; 3730098383; 3730098731; 3730099847; 3730100631; 3730100943; 3730101676; 3730102065; 3730102769; 3730103158; 3730104081; 3730104409; 3730105168; 3730105521; 3730106350; 3730106701; 3730107551; 3730107817; 3730086601; 3730087665; 3730087996; 3730088756; 3730089371; 3730090097; 3730090473; 3730091689; 3730092435; 3730092795; 3730094031; 3730094275; 3730095427; 3730096212; 3730096943; 3730097369; 3730098082; 3730098481; 3730099649; 3730100288; 3730100969; 3730101838; 3730102970; 3730104298; 3730105519; 3730106638; 3730088981; 3730090029; 3730090505; 3730091149; 3730091598; 3730092289; 3730092794; 3730093433; 3730093898; 3730094626; 3730095116; 3730095725; 3730096105; 3730096828; 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3730082484; 3730083784; 3730084724; 3730085439; 3730085910; 3730086661; 3730087411; 3730088127; 3730088809; 3730089876; 3730090551; 3730091001; 3730091775; 3730092619; 3730093051; 3730093784; 3730094295; 3730094871; 3730095436; 3730095960; 3730097048; 3730097628; 3730098152; 3730098630; 3730099805; 3730100449; 3730100934; 3730104837; 3730082490; 3730082910; 3730083650; 3730084148; 3730086070; 3730086594; 3730087347; 3730088091; 3730088748; 3730090059; 3730090926; 3730091687; 3730092038; 3730093180; 3730093710; 3730094343; 3730094815; 3730095474; 3730097676; 3730098524; 3730098989; 3730099552; 3730100199; 3730100721; 3730101854; 3730102649; 3730103544; 3730104271; 3730104694; 3730105624; 3730106133; 3730106810; 3730107273; 3730075990; 3730076694; 3730077241; 3730077647; 3730078312; 3730078856; 3730079995; 3730081206; 3730096632; 3730097604; 3730097915; 3730098560; 3730099182; 3730099722; 3730100772; 3730101229; 3730102079; 3730102312; 3730103167; 3730103611; 3730104320; 3730104671; 3730105395; 3730105785; 3730106649; 3730107102; 3730107673; 3730067512; 3730068156; 3730068538; 3730069168; 3730069410; 3730070586; 3730071328; 3730071766; 3730072441; 3730072840; 3730073537; 3730073967; 3730088379; 3730089853; 3730090210; 3730091062; 3730091498; 3730092148; 3730092602; 3730093268; 3730093726; 3730094454; 3730094922; 3730095596; 3730096019; 3730096691; 3730097108; 3730097771; 3730098233; 3730099353; 3730099783; 3730100438; 3730100852; 3730104884; 3730105450; 3730106926; 3730108060; 3730086571; 3730088525; 3730089801; 3730091416; 3730092095; 3730092543; 3730093189; 3730093657; 3730094402; 3730094873; 3730095559; 3730096654; 3730097096; 3730097723; 3730098866; 3730099303; 3730099989; 3730100373; 3730101092; 3730101529; 3730102202; 3730102597; 3730103363; 3730103813; 3730104502; 3730104973; 3730105662; 3730106124; 3730106839; 3730107311; 3730107991; 3730075360; 3730075714; 3730076387; 3730076626; 3730077586; 3730077808; 3730078643; 3730078968; 3730079785; 3730079911; 3730080897; 3730081248; 3730082381; 3730082611; 3730083562; 3730083854; 3730084635; 3730085092; 3730085987; 3730086238; 3730087050; 3730087485; 3730088263; 3730088789; 3730089479; 3730089989; 3730090728; 3730091121; 3730091810; 3730092231; 3730092917; 3730093373; 3730094087; 3730103889; 3730104186; 3730104938; 3730105339; 3730106027; 3730106542; 3730107254; 3730107745; 3730086837; 3730088508; 3730090037; 3730090542; 3730091256; 3730091677; 3730092859; 3730094038; 3730095692; 3730096255; 3730096852; 3730097290; 3730099297; 3730101063; 3730101499; 3730069135; 3730069435; 3730070812; 3730063803; 3730064167; 3730064783; 3730065575; 3730065954; 3730066764; 3730067155; 3730067725; 3730068435; 3730068914; 3730069560; 3730069986; 3730070511; 3730071020; 3730071585; 3730072267; 3730072699; 3730073645; 3730074245; 3730074797; 3730075426; 3730075874; 3730076645; 3730077316; 3730077859; 3730078387; 3730079017; 3730079541; 3730080243; 3730080963; 3730081358; 3730082106; 3730082796; 3730083154; 3730083960; 3730084526; 3730085146; 3730086411; 3730086956; 3730087611; 3730088324; 3730089124; 3730089619; 3730090290; 3730091737; 3730092366; 3730093097; 3730094004; 3730094487; 3730095292; 3730095738; 3730096461; 3730097348; 3730097634; 3730098461; 3730098649; 3730099641; 3730099757; 3730100718; 3730101110; 3730101895; 3730102486; 3730103079; 3730104122; 3730104251; 3730105278; 3730105343; 3730106421; 3730106925; 3730061461; 3730063964; 3730064027; 3730068258; 3730068503; 3730068472; 3730073867; 3730075376; 3730075940
RECALLING FIRM/MANUFACTURER
Recalling Firm: Talecris Plasma Resources, Inc., Research Triangle Park, NC, by facsimile and letter between January 13, 2010 and April 1, 2010.
Manufacturer: Talecris Plasma Resources, Inc., El Paso, TX. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6,760 units
DISTRIBUTION
NC, CA
________________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-2008-11;
2) Red Blood Cells. Recall # B-2009-11;
3) Platelets. Recall # B-2010-11
CODE
1) Unit: 8885051;
2) Units: 8885051; 1570368;
3) Unit: 1570368
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Miami, FL, by telephone and letter on May 18, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
VA, FL
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
________________________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-1893-11
CODE
Units: GC65540, GC65543, GC65953, GC65975
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Sacramento, CA, by telephone on October 2, 2007. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
________________________________________
PRODUCT
1) Red blood cells leukocytes reduced. Recall # B-1945-11;
2) Fresh frozen plasma. Recall # B-1946-11
CODE
1) and 2) Unit: 020S75093
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by telephone and facsimile on January 11 and January 12, 2005. Firm initiated recall is complete.
REASON
Blood products, collected using expired blood collection sets, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, UT
________________________________________
PRODUCT
Source Plasma. Recall # B-2011-11
CODE
Unit: 5140099249
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Newport News, VA, by e-mail on July 1, 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
Austria
________________________________________
PRODUCT
Source Plasma. Recall # B-2012-11
CODE
Units: 4550104629, 4550104330, 4550103789, 4550103285
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Columbia, SC, by e-mail on July 5, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC
________________________________________
PRODUCT
Source Plasma. Recall # B-2014-11
CODE
Units: 4640173926, 4640173398
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Las Vegas, NV, by e-mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
________________________________________
PRODUCT
Source Plasma. Recall # B-2015-11
CODE
Unit: 4640169878
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Las Vegas, NV, by e-mail on July 1, 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
Austria
________________________________________
PRODUCT
Source Plasma. Recall # B-2016-11
CODE
Unit: 5290048794
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Greenville, MS, by e-mail on July 1, 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
Austria
________________________________________
PRODUCT
Source Plasma. Recall # B-2017-11
CODE
Units: 4640184057, 4640183718, 4640183003, 4640180870, 4640180451, 4640178158, 4640176278, 4640175939
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Las Vegas, NV, by e-mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
Austria
________________________________________
PRODUCT
Source Plasma. Recall # B-2018-11
CODE
Units: 4610086592, 4610086272, 4610085769
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Monroe, LA, by e-mail on July 5, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC
________________________________________
PRODUCT
Source Plasma. Recall # B-2019-11
CODE
Units: 4640170754, 4640169999, 4640169677
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Las Vegas, NV, by e-mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria
________________________________________
PRODUCT
Source Plasma. Recall # B-2020-11
CODE
Units: 4640185145, 4640184783, 4640184055, 4640183719, 4640182070, 4640180871, 4640180450, 4640178161, 4640174540
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Las Vegas, NV, by e-mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Austria
________________________________________
PRODUCT
Source Plasma. Recall # B-2048-11
CODE
Units: 4290040290; 4290036879; 4290036640; 4290036170; 4290041453; 4290040586
RECALLING FIRM/MANUFACTURER
Ibr Plasmacenters, LLC, Garland, TX. Firm initiated recall is complete.
REASON
Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA
________________________________________
PRODUCT
Source Plasma. Recall # B-2049-11
CODE
Unit: WN0229571
RECALLING FIRM/MANUFACTURER
DCI Biologicals Wilmington, Inc.Wilmingto, NC, by facsimile on May 19, 2011 and e-mail on July 22, 2011. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined subsequent to receiving post donation medication information, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
UK
________________________________________
PRODUCT
Source Plasma. Recall # B-2050-11
CODE
Unit: 5070101553
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Inc., Birmingham, AL, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
________________________________________
PRODUCT
Source Plasma. Recall # B-2052-11
CODE
Units: 3870133416, 3870131931, 3870135323; 3870133704
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Springfield, IL, by electronic mail on July 1, 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
4 units
DISTRIBUTION
NC
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
________________________________________
PRODUCT
HOLDEX Single-Use Holder PP closed pack. A sterile single-use disposable holder with an off-center female luer at the top of the holder and epoxy bonded stainless steel needle on the underside of the holder, recommended for use with commercially available butterfly and luer needles in routine venipuncture procedures. Item number: 450263D. Recall # Z-2957-2011
CODE
Lot number A1008033
RECALLING FIRM/MANUFACTURER
Recalling Firm: Greiner Bio-One North America, Inc., Monroe, NC, by letter dated June 29, 2011.
Manufacturer: Greiner Bio-One Gmbh, Kremsmunster, Austria. Firm initiated recall is ongoing.
REASON
At removal of the tube from the holder, the needle may dislodge and blood spill can occur.
VOLUME OF PRODUCT IN COMMERCE
142,400 pieces
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
Lenstar LS 900 EyeSuite Biometry version i2.000, Four (4) Protective Cardboard Containers Per Each System. A non-invasive, non-contact OLCR (Optical Low Coherence Reflectometer) Biometer used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of IOL (Intraocular Lens) for implantation after removal of the natural crystalline lens following cataract removal. Part Number 7220162. Recall # Z-2964-2011
CODE
Serial Numbers: 21, 127, 223, 224, 284, 285, 316, 318, 319, 320, 322, 323, 324, 325, 326, 327, 328, 330, 331, 332, 333, 364, 365, 366, 368, 369, 371, 372, 376, 378, 379, 381, 384, 385, 386, 405, 407, 408, 409, 411, 412, 413, 414, 415, 416, 417, 418, 419, 420, 421, 423, 424, 443, 446, 447, 448, 449, 450, 452, 453, 454, 455, 456, 457, 458, 459, 460, 463, 469, 470, 481, 482, 483, 484, 485, 486, 487, 489, 490, 491, 492, 493, 494, 495, 496, 497, 499, 500, 527, 528, 529, 531, 532, 533, 535, 536, 537, 538, 539, 540, 541, 542, 543, 544, 545, 546, 547, 548, 549, 550, 551, 552, 558, 559, 560, 561, 563, 564, 565, 566, 567, 568, 569, 570, 571, 572, 573, 574, 576, 578, 579, , 581, 582, 583, 584, 585, 587, 588, 589, 590, 618, 619, 620, 621, 622, 624, 625, 626, 628, 630, 631, 632, 633, 634, 635, 636, 638, 639, 640, 641, 643, 644, 645, 647, 648, 649, 650, 651, 652, 653, 654, 656, 657, 658, 659, 660, 661, 662, 663, 665, 667, 668, 669, 670, 671, 672, 674, 675, 676, 677, 721, 723, 724, 725, 726, 727, 728, 729, 735, 824, 825, 922, 946, 966, 967, 968, 970, 1018, 1019, 1021, 1022, 1024, 1025, 1114, 1143 & 1195
RECALLING FIRM/MANUFACTURER
Recalling Firm: Haag-Streit USA Inc., Mason, OH, by letter dated June 20, 2011.
Manufacturer: Haag Streit Ag, Koeniz, Switzerland. Firm initiated recall is ongoing.
REASON
A patient record may be linked to an incorrect/inconsistent set of calculation results under specific circumstances when using EyeSuite Software version i2.000.
VOLUME OF PRODUCT IN COMMERCE
216 units
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
1) Infinity Delta Portable Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications. Catalog Number(s): MS18597/MS18852. Recall # Z-3047-2011;
 
2) Infinity Gamma X XL Portable Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications. Catalog Number(s): MS18597/MS18852. Recall # Z-3048-2011
CODE
1) Serial numbers (US): 6001227774, 6001229772, 6001083376, 6001100483, 6001191277, 6001193373, 6001272680, 6001263779, 6001233678, 6001281679, 6001306582, 6001078774, 6001238370, 6001212879, 6001282972, 6001285969, 6001296369, 6001296467, 6001267374, 6001316580, 6001103186, 6001282776, 6001233580, 6001242579, 6001246174, 6001267472, 6001465775, 6001093775, 6001219774, 6001230476, 6001234873, and 6001235676;
 
2) Serial numbers (US): 6001246076, 6001246575, 6001247173, 6001365874, 6001067474, 6001073681, 6001073779, 6001073877, 6001095176, 6001098966, 6001099466, 6001069472, 6001077080, 6001198466, 6001216679, 6001229674, 6001208082, 6001211782, 6001218178, 6001220086, 6001243676, 6001246771, 6001245968, 6001357179, 6001214877, 6001075679, 6001077178, 6001083180, and 6001095773
RECALLING FIRM/MANUFACTURER
Draeger Medical Systems, Inc., Telford, PA, by letters dated July 2011. Firm initiated recall is ongoing.
REASON
Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically.
VOLUME OF PRODUCT IN COMMERCE
1,076 units
DISTRIBUTION
Nationwide and Internationally
________________________________________
PRODUCT
High-Definition 120 Multileaf Collimator HD 120 MLC is an accessory x-ray collimator designed to be mounted on Varian Trilogy Tx and Trilogy linear accelerators and is intended to shape s-ray field perimeter. Field shape can be either static (fixed) or dynamic. The intended use is to assist clinician in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
Model Numbers: H56, HHM. Recall # Z-3052-2011
CODE
Code numbers: HHM0018, HHM1202, H561174, H561044, H561076, H561016, H561142, H561040, H561176, H561170, H561111 H561011, H561154, H561017, H561141, H561172, H561163, H561205, H561178, H561121, HHM0028, H561156, HHM0017, H561130, H561137 H561008, H561010, H561191, H561162, H561187, H561147, H561009, H561203 HHM0035 HHM0039, H561206 H561159 H561152 HHM0005 HHM0023 H561027 H561144 H561166 H561146 H561067 H561190 H561140 H561034 H561050 H561112 H561046 HHM0012 HHM0010 H561123 H561113 H561173 H561106 H561114 H561020 HHM0033 H561118 H561195 H561064 H561096 HHM0019 H561193 H561138 H561148 H561061 H561059 H561185 H561169 H561041 H561151 HHM0007 H561204 HHM0006 H561117 H561052 H561136 H561179 HHM0032 H561150 H561045 H561157 H561175 H561116 H561037 HHM0030 H561018 H561199 H561167 H561063 H561028 H561194 H561023 H561070 H561153 H561145 H561043 H561171 H561180 H561127 H561201 H561107 H561048 H561104 H561026 H561139 H561160 H561207 H561208 HHM0029 HHM0016 HHM0024 H561031 H561025 H561062 H561006 H561057 H561200 H561182 HHM0014 H561186 HHM0025 H561021 H561158 H561105 H561126 HHM0027 H561161 H561033 H563989 HHM0009 H561134 H561101 H561069 H564795 H561102 H561030 H561168 H561128 H561109 H561120 H561196 HHM0015 H561135 H561115 H561013 H561110 H561058 H561035 H561100 HHM0013 H561053 H561019 H561149 HHM0031 HHM0008 H561012 H561024 H561022 H561103 H561039 H561038 H561124 HHM0026 HHM0004 H561189 H561036 H561029 H561015 H561060
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated June 6, 2011. Firm initiated recall is ongoing.
REASON
When using the HD120 Multi Leaf Collimator for beam shaping, and under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceeds the expected transmission dose.
VOLUME OF PRODUCT IN COMMERCE
173 units
DISTRIBUTION
Nationwide and Internationally
________________________________________
PRODUCT
Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); catalog number SIM-220A. The STROMATOLYSER-IM lysing reagent is used to destroy red blood cells to aid in the counting and characterization on immature white blood cells. This reagent is used on the Sysmex XE-Series and SE Series hematology analyzers. Catalog number SIM-220A. Recall # Z-3063-2011
CODE
Lot numbers: Y0053, Y0054, Y0055
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sysmex America, Inc., Mundelein, IL, by letter dated April 2011.
Manufacturer: Sysmex Reagents America Inc., Mundelein, IL. Firm initiated recall is ongoing.
REASON
The affected lots of Stromatolyser-IM lysing reagent were found to be contaminated with Pseudomonas bacteria, which resulted in rising IMI channel background counts, increased false "Platelet Clump" flags and a strong sulfur-like odor when used on the XE-2100, XE-2100L and XE-5000 analyzers.
VOLUME OF PRODUCT IN COMMERCE
1,887 cubetainers
DISTRIBUTION
Nationwide, PR, Canada, Columbia, Ecuador, Mexico, Netherland, Antilles and Peru
________________________________________
PRODUCT
Model 754/754M Disposable. Accessory for 700 Series 754/754m Ventilators during MRI examinations. Catalog/Code # 820-0092-00. Recall # Z-3080-2011.
CODE
None
RECALLING FIRM/MANUFACTURER
Impact Instrumentation, Inc., West Caldwell, NJ, by letter dated May 27, 2011. Firm initiated recall is ongoing.
REASON
Circuits are being distributed without market clearence (510k).
VOLUME OF PRODUCT IN COMMERCE
492 units
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
1) Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Ref: BL5110, packaged 6 units/case, RX, Sterile. For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery. Recall # Z-3087-2011;
 
2) Bausch & Lomb Stellaris Basic Vacuum Phaco Pack, Ref: BL5111, packaged 6 units/case, RX, Sterile. For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery. Recall # Z-3088-2011;
 
3) Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112, packaged 6 units/case, RX, Sterile. For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery. Recall # Z-3089-2011;
 
4) Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle, Ref: BL5114, packaged 6 units/case, RX, Sterile. For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery. Recall # Z-3090-2011
CODE
1) Lot #U6480, Exp. 11/2012;
2) Lot #U6481, Exp. 11/2012;
3) Lot #U6476, Exp. 11/2012;
4) Lot #U6482, Exp. 11/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb Inc., Rochester, NY, by telephone and FAX or e-mail dated July 27, 2011.
Manufacturer: Bausch & Lomb Inc. Saint Louis, MO. Firm initiated recall is ongoing.
REASON
The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction
VOLUME OF PRODUCT IN COMMERCE
246/6-unit cases
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
1) Encision AEM Suction Irrigation Electrode, L-Diamond, REF ES3881. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor. Recall # Z-3093-2011;
 
2) Encision AEM Suction Irrigation Electrode, Spatula, REF ES3882. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor. Recall # Z-3094-2011;
 
3) Encision AEM Suction Irrigation Electrode, L-Hook, Catalog: REF ES3883. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor. Recall # Z-3095-2011;
 
4) Encision AEM Suction Irrigation Electrode, J-Hook, Catalog: REF ES3884. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor. Recall # Z-3096-2011;
 
5) Encision AEM Suction Irrigation Electrode, Needle Tip, Catalog: REF ES3885. Recall # Z-3097-2011
CODE
1) Lots: QI, RA, and RE;
2) Lots: QI, RA, RD, RE and RF;
3) Lots QI, RA, and RE;
4) Lots: QI, RA, and RE;
5) Lots: QI and RA.
RECALLING FIRM/MANUFACTURER
Encision, Inc., Boulder, CO, by letter dated August 24, 2011. Firm initiated recall is ongoing.
REASON
Electrode tips have been reported breaking off during use or cleaning.
VOLUME OF PRODUCT IN COMMERCE
1,078 units
DISTRIBUTION
Nationwide and New Zealand
________________________________________
PRODUCT
BrachyVision, versions 8.2, 8.5, 8.6 and 8.9. Used to plan radiotherapy treatments for patients with malignant or benign diseases. In addition, the module is specifically indicated for planning proton treatment of neoplasms of the eye. Recall # Z-3103-2011
CODE
Versions 8.2, 8.5, 8.6 and 8.9
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc., Charlottesville, VA, by letter dated August 05, 2010. Firm initiated recall is complete
REASON
Medical device for brachytherapy treatment may cause users to enter incorrect syntax and lead to potential misinterpretation of patient treatment plan.
VOLUME OF PRODUCT IN COMMERCE
1,252 units
DISTRIBUTION
Nationwide and Internationally
________________________________________
PRODUCT
Varian Treatment version 6.6.5052. Intended to provide accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by preventing the radiation therapy device form commencing irradiation while any linear accelerator parameter is out of conformance with the treatment plan. Model H48. Recall # Z-3105-2011
CODE
Serial numbers: H460150 H462049 H462100 H463014 H463044 H463077 H466021 H466036 H466051 H466067 H460907 H462050 H462123 H463015 H463052 H463078 H466022 H466037 H466052 H466068 H461000 H462051 H462124 H463016 H463053 H463080 H466023 H466038 H466053 H466069 H462003 H462055 H462127 H463017 H463054 H463082 H466024 H466039 H466054 H466075 H462004 H462057 H463000 H463018 H463061 H463083 H466025 H466040 H466055 H466082 H462005 H462061 H463001 H463020 H463062 H463093 H466026 H466041 H466056 H466086 H462006 H462072 H463004 H463024 H463064 H463218 H466027 H466043 H466059 H466091 H462011 H462079 H463006 H463038 H463065 H463377 H466028 H466044 H466061 H466092 H462024 H462080 H463008 H463039 H463068 H465519 H466029 H466045 H466062 H468097 H462030 H462082 H463010 H463040 H463070 H466001 H466030 H466046 H466064 H468098 H462045 H462089 H463012 H463042 H463071 H466011 H466031 H466047 H466065 H462048 H462095 H463013 H463043 H463075 H466017 H466032 H466050 H466066
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters dated July 20, 2011. Firm initiated recall is ongoing.
REASON
Potential for Varian Treatment application failing to load the physical wedge filter for a treatment field on a Siemens Mevatron linear accelerator. Delivery of a treatment field without the planned wedge would deliver more dose than intended and would change the shape of the dose distribution for that field.
VOLUME OF PRODUCT IN COMMERCE
118 units
DISTRIBUTION
Nationwide and Internationally
________________________________________
PRODUCT
DrugCheck. Following cup Model numbers involved in the recall: 60670, 60700, 60713, 60717, 60870, 60923, 61012, 61019, 61023, 61024, 61040, 61042, 61057, 61102, 61105, 61203, 61204, 61206, 61208, 61301, 61303, 61401, 70603, 70809, 71032, 71043, 71055, 71065, 71202, 71204, 71205, 71401, 71402, 60718-3, 60720-6, 60925-A, 60927-3, 60930-A, 60980-3A, 61002-3, 61010-4, 61023-A, 61028-3A, 61039-4, 61040-A, 61055-A, 61056-3, 61057-6, 61100-3, 61102-3,61104-3,61105-5 CRL,61120-3,61202-4,61204-4,61204-A,61206-3A,61207-4,61302-3, 61303-A, 61401-A, 70660-3, 70716-3, 71045-A, 71055-6, 71102-3A, 71204-4, 71206-3A. In Vitro immunoassay screening device for the qualitative detection of multiple drugs of substances in human urine. Recall # Z-3113-2011
CODE
Product Lot # 60670 670052010 60670 670070209 60670 670101409 60670 670110409 60670 670121609 60700 700031910 60700 700040709 60700 700042810 60700 700060310 60700 700062209 60700 700062510 60700 700071509 60700 700072209 60700 700072310 60700 700081309 60700 700090110 60700 700090409 60700 700110409 60700 700121009 60700 700122909 60713 713030310 60713 713072109 60717 717040110 60717 717051510 60717 717051810 60717 717070610 60717 717082310 60870 870020110 60870 870042810 60923 923012010 60923 923042010 60923 923050509 60923 923060109 60923 923062210 60923 923062909 60923 923080409 60923 923082310 60923 923100709 60923 923111009 60923 923120209 61012 12071910 61019 19072110 61019 19121609 61023 23020910 61023 23052810 61023 23060909 61023 23061610 61023 23062309 61023 23082009 61023 23082509 61023 23110409 61024 24021910 61024 24050609 61024 24051310 61024 24062210 61024 24070709 61024 24071709 61024 24072910 61024 24082609 61024 24090909 61024 24102309 61024 24122909 61024 24151310 61024 27071709 61040 40110308 61042 42080910 61057 57080610 61102 102052410 61102 102052909 61102 102061610 61102 102061709 61102 102081009 61102 102090909 61102 102092509 61102 102103009 61102 102121409 61105 105032310 61203 203101209 61204 204021910 61204 204051310 61204 204062210 61204 204070709 61204 204102309 61204 204122909 61206 206012110 61206 206050510 61206 206050510 61208 208072310 61208 208090109 61208 208090110 61208 208111209 61208 208112309 61301 301010710 61301 301011910 61301 301101409 61303 303121009 61401 401010510 61401 401011910 61401 401030310 61401 401040710 61401 401042810 61401 401052010 61401 401070710 61401 401072810 61401 401091409 61401 401100709 61401 401121709 70603 603080310 70809 809091010 71032 32022310 71032 32050710 71032 32051209 71032 32052209 71032 32060810 71032 32071410 71032 32081809 71032 32091709 71032 32103009 71032 32112309 71043 43061010 71043 43062209 71043 43070609 71043 43071210 71043 43072209 71043 43081709 71043 43082410 71043 43090209 71055 55011110 71055 55012610 71055 55022310 71055 55031609 71055 55031710 71055 55052709 71055 55060110 71055 55061610 71055 55070209 71055 55070509 71055 55070710 71055 55082609 71055 55091709 71055 55102009 71055 55111909 71055 55112309 71055 55031710 71065 65012610 71065 65040809 71065 65042010 71065 65072809 71065 65082609 71065 65091710 71065 65100109 71202 202011510 71202 202081709 71202 202111909 71204 204010510 71204 204030510 71204 204041210 71204 204041910 71204 204050510 71204 204051409 71204 204060310 71204 204061509 71204 204062509 71204 204070710 71204 204072810 71204 204080409 71204 204081009 71204 204081309 71204 204082510 71204 204090309 71204 204090909 71204 204091310 71204 204092109 71204 204100609 71204 204102309 71204 204111809 71204 204111909 71204 204120809 71204 204121409 71204 204123109 71205 205010710 71205 205031910 71205 205070910 71205 205072510 71205 205072810 71205 205100909 71205 205110309 71401 401031610 71402 402041210 60718-3 3718040110 60718-3 3718091010 60720-6 6720082310 60925-A A925081209 60927-3 3927011410 60927-3 3927060209 60930-A A930081110 60980-3A 3A980070109 61002-3 3102052609 61010-4 401052010 61010-4 401063010 61010-4 401080210 61010-4 401083109 61010-4 401110209 61010-4 401111109 61010-4 401113009 61023-A A023051110 61023-A A023010710 61023-A A023041210 61023-A A023081109 61028-3A 3A028010510 61028-3A 3A028032210 61028-3A 3A028060109 61028-3A 3A028092909 61039-4 4039020110 61039-4 4039032310 61039-4 4039042009 61039-4 4039050110 61039-4 4039051110 61039-4 4039061510 61039-4 4039073109 61039-4 4039102009 61040-A A040080210 61055-A A055040110 61056-3 3056061410 61057-6 6057062510 61100-3 3100082509 61102-3 3102012610 61102-3 3102021110 61102-3 3102032310 61102-3 3102040710 61102-3 3102041410 61102-3 3102041509 61102-3 3102051310 61102-3 3102052609 61102-3 3102062510 61102-3 3102062909 61102-3 3102070610 61102-3 3102071910 61102-3 3102082009 61102-3 3102082509 61102-3 3102090209 61102-3 3102093009 61102-3 3102102009 61102-3 3102121409 61104-3 3104012010 61104-3 3104021110 61104-3 3104031610 61104-3 3104041510 61104-3 3104042810 61104-3 3104072110 61104-3 3104072210 61104-3 3104081710 61104-3 3104091010 61104-3 3104102209 61104-3 3104102909 61104-3 3104110209 61104-3 3104121609 61105-5 CRL CRL5105062210 61105-5 CRL CRL5105081110 61105-5 CRL CRL5105082710 61120-3 3102102009 61202-4 4202012010 61202-4 4202012909 61202-4 4202032509 61202-4 4202041509 61202-4 4202060410 61202-4 4202061909 61202-4 4202090809 61202-4 4202092909 61202-4 4202122909 61204-4 4202012010 61204-4 4204041509 61204-4 4204061909 61204-A A204030810 61204-A A204050310 61204-A A204061010 61204-A A204062609 61204-A A204072909 61204-A A204100609 61204-A A204121409 61204-A A207072909 61206-3A 3A206032310 61207-4 4207012610 61207-4 4207042810 61207-4 4207062310 61207-4 4207071610 61207-4 4207072409 61207-4 4207111309 61302-3 3203032910 61302-3 3302020310 61302-3 3302021510 61302-3 3302021809 61302-3 3302060810 61303-A A303031909 61401-A A401031510 70660-3 3660081009 70716-3 3716060109 71045-A A045081909 71055-6 6055052610 71102-3A 3A102082709 71204-4 4204010710 71204-4 4204081310 71206-3A 3A102082709 71206-3A 3A206012110 71206-3A 3A206070109 71206-3A 3A206071009 71206-3A 3A206081109 71206-3A 3A206090809 71206-3A 3A206091709 71206-3A 3A206121409 72106-3A 3A206081109
RECALLING FIRM/MANUFACTURER
Express Diagnostics Int'l., Inc., Blue Earth, MN, by letter dated October 4, 2010. Firm initiated recall is ongoing.
REASON
Express Diagnostics Int'l, Inc (EDI), is recalling DrugCheck Drug Screen Cups containing buprenorphine (BUP) and propoxyphene (PPX) because they must be labeled as "forensic use only", meaning they cannot be distributed or used for treatment or diagnostic purposed in the United States.
VOLUME OF PRODUCT IN COMMERCE
196,750 units
DISTRIBUTION
AZ, CA, CT, GA, MD, MA, MN, MO, NH, NJ, OR, SC, and WA
________________________________________
PRODUCT
TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite. The TiLite ZR had a model catalog number of Z2FS1. The TiLite ZRA has a model catalog number of Z2FS2. Provide mobility for physically impaired individuals. Recall # Z-3161-2011
CODE
Units: 52359, 52493, 52501, 52532, 52552, 52586, 52588, 52590, 52632, 52689, 52700, 52718, 52722, 52737, 52740, 52754, 52760, 52778, 52785, 52792, 52804, 52820, 52824, 52830, 52833, 52836, 52842, 52847, 52856, 52862, 52874, 52875, 52879, 52899, 52911, 52918, 52924, 52926, 52951, 52958, 52978, 52979, 52982, 52994, 52997, 52998, 52999, 53008, 53014, 53034, 53038, 53048, 53051, 53070, 53089, 53094, 53111, 53120, 53123, 53146, 53163, 53174, 53186, 53206, 53209, 53219, 53222, 53236, 53242, 53250, 53254, 53256, 53258, 53259, 53260, 53265, 53267, 53270, 53274, 53276, 53285, 53286, 53287, 53290, 53294, 53295, 53299, 53303, 53316, 53335, 53343, 53396, 53427, 53436, 53444, 53454, 53458, 53465, 53467, 53487, 53490, 53493, 53497, 53504, 53509, 53511, 53520, 53525, 53526, 53533, 53534, 53542, 53543, 53547, 53551, 53555, 53564, 53569, 53570, 53580, 53585, 53591, 53610, 53635, 53641, 53660, 53674, 53695, 53711, 53713, 53723, 53727, 53734, 53740, 53756, 53780, 53790, 53794, 53800, 53801, 53812, 53821, 53823, 53826, 53829, 53835, 53836, 53838, 53839, 53841, 53860, 53862, 53864, 53865, 53870, 53874, 53882, 53883, 53885, 53891, 53907, 53909, 53911, 53914, 53917, 53935, 53955, 53956, 53972, 53978, 53988, 53996, 54006, 54012, 54023, 54035, 54062, 54079, 54083, 54088, 54097, 54102, 54114, 54118, 54124, 54127, 54129, 54139, 54159, 54168, 54178, 54187, 54190, 54195, 54196, 54202, 54206, 54211, 54218, 54221, 54223, 54237, 54242, 54243, 54244, 54278, 54281, 54282, 54297, 54317, 54321, 54325, 54339, 54341, 54349, 54354, 54356, 54365, 54381, 54383, 54385, 54386, 54390, 54395, 54413, 54415, 54416, 54422, 54445, 54448, 54450, 54451, 54464, 54468, 54470, 54478, 54493, 54500, 54520, 54534, 54539, 54540, 54541, 54552, 54558, 54559, 54566, 54567, 54569, 54576, 54579, 54584, 54595, 54607, 54608, 54613, 54625, 54643, 54648, 54661, 54662, 54674, 54684, 54685, 54690, 54694, 54695, 54711, 54717, 54720, 54723, 54727, 54728, 54733, 54735, 54737, 54742, 54744, 54746, 54749, 54752, 54760, 54763, 54764, 54765, 54772, 54778, 54781, 54783, 54793, 54795, 54801, 54807, 54812, 54813, 54815, 54816, 54820, 54825, 54829, 54831, 54832, 54836, 54838, 54839, 54846, 54848, 54853, 54862, 54865, 54870, 54875, 54876, 54877, 54884, 54885, 54890, 54893, 54902, 54917, 54929, 54930, 54932, 54940, 54942, 54953, 54955, 54971, 54973, 54978, 54979, 54980, 54981, 54982, 54985, 54986, 54987, 54989, 54990, 54993, 55003, 55009, 55027, 55031, 55032, 55034, 55037, 55040, 55041, 55046, 55048, 55059, 55060, 55079, 55083, 55091, 55105, 55106, 55109, 55123, 55125, 55149, 55171, 55180, 55183, 55200, 55203, 55209, 55211, 55222, 55236, 55237, 55244, 55251, 55255, 55256, 55258, 55261, 55262, 55268, 55274, 55288, 55292, 55298, 55314, 55317, 55319, 55322, 55324, 55325, 55326, 55327, 55331, 55336, 55337, 55342, 55346, 55352, 55358, 55359, 55370, 55383, 55385, 55389, 55402, 55406, 55407, 55414, 55415, 55418, 55421, 55429, 55435, 55437, 55439, 55442, 55447, 55453, 55455, 55459, 55461, 55467, 55472, 55476, 55477, 55488, 55492, 55496, 55499, 55506, 55512, 55514, 55527, 55529, 55531, 55535, 55550, 55555, 55567, 55581, 55582, 55583, 55585, 55587, 55591, 55593, 55595, 55607, 55620, 55632, 55644, 55646, 55666, 55668, 55670, 55673, 55676, 55682, 55690, 55694, 55697, 55706, 55710, 55712, 55713, 55714, 55717, 55718, 55725, 55729, 55730, 55732, 55735, 55742, 55753, 55754, 55756, 55758, 55763, 55767, 55768, 55777, 55787, 55822, 55828, 55847, 55861, 55876, 55886, 55891, 55894, 55896, 55904, 55908, 55912, 55913, 55914, 55917, 55918, 55919, 55921, 55928, 55929, 55931, 55932, 55936, 55937, 55938, 55939, 55940, 55941, 55944, 55946, 55948, 55949, 55950, 55951, 55954, 55959, 55960, 55964, 56015, 56017, 56019, 56020, 56021, 56026, 56030, 56038, 56064, 56069, 56070, 56079, 56080, 56084, 56089, 56092, 56093, 56095, 56101, 56104, 56106, 56112, 56117, 56119, 56124, 56125, 56127, 56128, 56132, 56133, 56134, 56135, 56145, 56149, 56151, 56159, 56161, 56170, 56190, 56193, 56196, 56198, 56200, 56208, 56213, 56226, 56236, 56239, 56243, 56244, 56245, 56250, 56254, 56260, 56266, 56272, 56276, 56278, 56284, 56287, 56298, 56305, 56311, 56327, 56328, 56329, 56332, 56341, 56344, 56348, 56349, 56354, 56356, 56359, 56360, 56367, 56370, 56372, 56375, 56377, 56394, 56427, 56447, 56462, 56463, 56467, 56468, 56470, 56476, 56482, 56485, 56487, 56497, 56498, 56502, 56507, 56510, 56512, 56514, 56515, 56522, 56523, 56529, 56531, 56534, 56540, 56542, 56545, 56557, 56560, 56563, 56570, 56573, 56575, 56577, 56578, 56581, 56584, 56588, 56592, 56600, 56601, 56611, 56618, 56619, 56623, 56624, 56628, 56631, 56639, 56640, 56643, 56646, 56650, 56652, 56653, 56654, 56659, 56661, 56663, 56675, 56679, 56684, 56686, 56687, 56694, 56705, 56711, 56712, 56716, 56717, 56718, 56719, 56729, 56734, 56736, 56743, 56744, 56748, 56749, 56752, 56755, 56768, 56771, 56773, 56784, 56791, 56794, 56795, 56805, 56811, 56813, 56817, 56823, 56834, 56838, 56845, 56857, 56865, 56880, 11902420, 11902447, 11902458, 11902461, 11902463, 11902464, 11902473, 11902475, 11902479, 11902484, 11902486, 11902487, 11902488, 11902491, 11902501, 11902510, 11902514, 11902516, 11902518, 11902519, 11902521, 11902527, 11902537, 11902538, 11902539, 11902544, 11902552, 11902553, 11902565, 11902567, 11902571, 11902572, 11902573, 11902576, 11902578, 11902579, 11902600, 11902603, 11902605, 11902614, 11902616, 11902621, 11902626, 11902627, 11902633, 11902643, 11902644, 11902645, 11902646, 11902647, 11902648, 11902654, 11902661, 11902663, 11902664, 11902665, 11902676, 11902680, 11902681, 11902688, 11902690, 11902693, 11902697, 11902700, 11902708, 11902710, 11902713, 11902723, 11902730, 11902735, 11902736, 11902737, 11902738, 11902739, 11902741, 11902743, 11902744, 11902749, 11902751, 11902756, 11902763, 11902767, 11902770, 11902778, 11902782, 11902783, 11902784, 11902793, 11902795, 11902796, 11902803, 11902804, 11902812, 11902814, 11902816, 11902819, 11902824, 11902830, 11902838, 11902839, 11902844, 11902845, 11902847, 11902868, 11902878, 11902880, 11902893, 11902897, 11902898, 11902905, 11902909, 11902911, 11902912, 11902915, 11902916, 11902920, 11902921, 11902939, 11902941, 11902946, 11902948, 11902949, 11902957, 11902961, 11902964, 11902967, 11902974, 11902975, 11902978, 11902980, 11902987, 11902988, 11902989, 11902990, 11903018, 11903021, 11903025, 11903028, 11903035, 11903037, 11903044, 11903045, 11903051, 11903065, 11903070, 11903071, 11903077, 11903083, 11903088, 11903096, 11903100, 11903102, 11903107, 11903111, 11903115, 11903121, 11903125, 11903131, 11903133, 11903136, 11903138, 11903141, 11903143, 11903146, 11903151, 11903165, 11903170, 11903180, 11903187, 11903197, 11903198, 11903200, 11903202, 11903203, 11903204, 11903212, 11903213, 11903215, 11903216, 11903219, 11903224, 11903228, 11903235, 11903239, 11903249, 11903250, 11903257, 11903258, 11903260, 11903269, 11903270, 11903276, 11903277, 11903279, 11903290, 11903308, 11903317, 11903320, 11903337, 11903353, 11903355, 11903356, 11903357, 11903368, 11903381, 11903382, 11903396, 11903404, 11903406, 11903417, 11903421, 11903427, 11903429, 11903432, 11903434, 11903435, 11903444, 11903450, 11903475, 11903478, 11903479, 11903483, 11903488, 11903491, 11903497, 11903506, 11903508, 11903510, 11903515, 11903516, 11903517, 11903518, 11903537, 11903551, 11903553, 11903557, 11903565, 11903572, 11903582, 11903591, 11903592, 11903598, 11903602, 11903607, 11903612, 11903621, 11903658, 11903663, 11903672, 11903676, 11903688, 11903708, 11903714, 11903715, 11903721, 11903722, 11903727, 11903728, 11903730, 11903732, 11903734, 11903751, 11903766, 11903776, 11903782, 11903788, 11903791, 11903794, 11903805, 11903807, 11903808, 11903815, 11903819, 11903825, 11903829, 11903830, 11903840, 11903845, 11903846, 11903847, 11903850, 11903861, 11903874, 11903876, 11903882, 11903889, 11903896, 11903900, 11903903, 11903905, 11903908, 11903911, 11903914, 11903918, 11903927, 11903932, 11903936, 11903940, 11903949, 11903959, 11903960, 11903961, 11903962, 11903968, 11903974, 11903980, 11903981, 11903982, 11903985, 11903993, 11903999, 11904018, 11904019, 11904410, 11904413, 11904416, 11904418, 11904422, 11904426, 11904430, 11904431, 11904434, 11904445, 11904603, 11904605, 11904609, 11904611, 11904618, 11904626, 11904689, 11904690, 11904697, 11904705, 11904757, 11904896, and 53309A
RECALLING FIRM/MANUFACTURER
TiSport, Llc, Pasco , WA, by letter on July 5, 2011. Firm initiated recall is ongoing.
REASON
The Pivot Stud Bolt comprising part of the backrest assembly of TiLite ZR Series 2 and ZRA Series 2 mechanical wheelchairs have shown a tendency to fail due to the head of the bolt being sheared off.
VOLUME OF PRODUCT IN COMMERCE
1037 units
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
________________________________________
PRODUCT
Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. Packaged in 19 packages of 100 and 6 packages of 10. Highland Metals, Inc. Wire used for orthodontic treatment to place in the brackets to shape teeth. Model: 001. P/N: 11219251124. Recall # Z-2963-2011
CODE
Lot # 34415
RECALLING FIRM/MANUFACTURER
Highland Metals, San Jose, CA, by e-mail and letter dated July 12, 2011. Firm initiated recall is ongoing.
REASON
Heat Activated Niti, Natural, Upper, 0.19 x 25" Arch wires mixed with size 021x0.25" Arch Wires.
VOLUME OF PRODUCT IN COMMERCE
10 packages of 100
DISTRIBUTION
Nationwide, Australia and Turkey
 
________________________________________
PRODUCT
"BIO-RAD***Kallestad Mouse Stomach/Kidney 8 Well Slides*** STORE FROZEN***" The test kit contains slides and substrate. For use as an indirect fluorescent antibody procedure for the detection and semi-quantitation of human autoantibodies. MSK catalog number: 30443. Recall # Z-3051-2011
CODE
Lot number: 101941. Slide Pack Lot number: 00100889006
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Redmond, WA, by telephone on June 30, 2010 and July 13, 2010. Firm initiated recall is complete.
REASON
KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides.
VOLUME OF PRODUCT IN COMMERCE
35 kits
DISTRIBUTION
Nationwide and PR
________________________________________
PRODUCT
Cell Marque antibody CD99 (H036-1.1) Mouse Monoclonal. The Cell Marque CD99 Mouse Monoclonal Antibody is intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in sections of formalin fixed, paraffin embedded tissue sections using manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic determination of human tumors within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist of physician. Recall # Z-3110-2011
CODE
Lot Number 1113202A, Exp date: 2014-04.
RECALLING FIRM/MANUFACTURER
Cell Marque Corp., Rocklin, CA, by telephone on July 12, 2011. Firm initiated recall is complete.
REASON
Incorrect label on product bottle, although labeling on outer box is correct.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Nationwide and Great Britain
 
END OF ENFORCEMENT REPORT FOR SEPTEMBER 14, 2011
 
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