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U.S. Department of Health and Human Services

Safety

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Enforcement Report for August 4, 2010

 

 
August 4, 2010                                                                                     10-30
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Vegetarian Roll, Vegetables and Marinated Tofu Wrapped with Seaweed and Rice. Product is packed 15 rolls in a clear cello pack, 8 pkgs/case. Cases labeled Sushi BAR by Golden Tiger Vegetarian Roll 57325 Ingredients: Rice, carrots, Tofu (Soybean Curd[Soybean, Water, Calcium Sorbate, Soybean Oil, Sugar, Vinegar Soy Sauce, Hydrolyzed Vegetable Protein) Vegetable Oil, Vinegar, Sugar, Seaweed, Salt, Sesame, Net Wt 5.625 lbs. UPC 10076366573257. Recall # F-2571-2010
CODE
Units: 7110103A, 7110122A, 7110123A, and 7110125A
RECALLING FIRM/MANUFACTURER
Curveset, LLC, dba Banzai Sushi, Seattle, WA, by telephone on June 10, 2010, followed with a letter dated June 18, 2010. Firm initiated recall is ongoing.
REASON
Some packages actually contained a different product, California Rolls which had several allergens including pollock, crab, egg, and wheat that were not listed on the label.
VOLUME OF PRODUCT IN COMMERCE
768 cases
DISTRIBUTION
Unknown
___________________________________
PRODUCT
1) Queso El Azteca brand QUESO FRESCO (Fresh White Cheese), Net Wt. 14 oz. (396g), UPC 0 23986 92692 8. The product is packed in a clear, hard plastic container or wrapped in aluminum foil. Recall # F-2573-2010;
 
2) Queso El Azteca brand Queso Herba (Fresh White String Cheese), Net Wt. 14 oz. (396g) and Net Wt. 5 lbs. (2.25K). The product is packaged in a vacuum sealed plastic bag. Recall # F-2574-2010
CODE
Expiration date of July 7, 2010
RECALLING FIRM/MANUFACTURER
Azteca Linda Corp., Brooklyn, NY, by press release on July 1, 2010. FDA initiated recall is ongoing.
REASON
The cheese products have the potential to be contaminated with Listeria monocytogenes based on FDA environmental sampling and inspectional findings.
VOLUME OF PRODUCT IN COMMERCE
Approx. 792 units
DISTRIBUTION
NY, NJ
___________________________________
PRODUCT   
1) Wally's Nut House Sweet Cajun Heat Mix, packaged in 16-oz. plastic bags. Recall # F-2575-2010;
 
2) Wally's Nut House Hot 'n Spicy Mix, packaged in 16-oz. plastic bags. Recall # F-2576-2010;
 
3) Wally's Nut House Louisiana Cajun Mix, packaged in 16-oz. plastic bags. Recall # F-2577-2010;
 
4) Wally's Nut House Tail Gate Crunch Mix, packaged in 16-oz. plastic bags. Recall # F-2578-2010;
 
5) Wally's Nut House Country Western Mix, packaged in 16-oz. plastic bags. Recall # F-2579-2010;
 
6) Wally's Nut House Party Mix, packaged in 16-oz. plastic bags. Recall # F-2580-2010;
 
7) Wally's Nut House Cranberry Raisin Mix, packaged in 16-oz. plastic bags. Recall # F-2581-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Wally's Nut House LLC, Oak Grove, MO, by press release on May 27, 2010 and telephone beginning May 28, 2010. FDA initiated recall is complete.
REASON
Undeclared allergens.
VOLUME OF PRODUCT IN COMMERCE
Approx. 1,870/16-oz. bags
DISTRIBUTION
MO
___________________________________
PRODUCT   
Garlic Spread Concentrate - Product is packaged in 4 oz. plastic clear jars with red cap. Label is red, white, yellow, black, green and blue with red, yellow & black, white black and blue writing on it. Further packaged into master cartons which contain six (6), 4 ounce jars/case. Recall # F-2583-2010
CODE
Lot # 92221, Lot # 92391, Lot # 92661, Lot # 92921, Lot # 93291, Lot # 100341, Lot # 100971, Lot # 101181;
RECALLING FIRM/MANUFACTURER
Soup Bases Loaded, Ontario, CA, by visit beginning June 25, 2010. Firm initiated recall is ongoing.
REASON
This recall has been initiated due to non- declared allergens Milk and Wheat ingredients on label. Consumption of this product may include potential allergenic health hazards.
VOLUME OF PRODUCT IN COMMERCE
8,698 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
1) Fresh Express 5 Lettuce Mix Salad, 6.00 oz. bag, UPC 2 71279 25101 1. Recall # F-2588-2010;
 
2) Fresh Express American Salad, 12.00 oz. bag, UPC 0 71279 24100 5. Recall # F-2589-2010;
 
3) Fresh Express Asian Supreme Completes Kit, 13.9 oz. bag, UPC 0 71279 30201 0. Recall # F-2590-2010;
 
4) Fresh Express BLT Caesar Completes Kit, 10.5 oz. bag, UPC 0 71279 30105 1. Recall # F-2591-2010;
 
5) Fresh Express Caesar Completes Kit, 10.00 oz. bag, UPC 0 71279 30100 6. Recall # F-2592-2010;
 
6) Fresh Express Caesar Supremes Completes Kit, 10.75 oz. bag, UPC 0 71279 30104 4. Recall # F-2593-3010;  
 
7) Fresh Express Salsa! Ensalada Supreme Completes Kit 14.00 oz. bag, UPC 0 71279 30601 8. Recall # F-2594-2010;
 
8) Fresh Express Double Carrots Kit 12.00 oz. bag, UPC 0 71279 10802 5. Recall # F-2595-2010;
 
9) Fresh Express Fancy Greens in 7.00 oz. bag, UPC 0 71279 10802 5. Recall # F-2596-2010;
 
10) Fresh Express Gourmet Cafe Caribbean Chicken kit in 8.6 oz bag, UPC code 0 71279 40705. Recall # F-2597-2010;
 
11) Fresh Express Gourmet Cafe Chicken Caesar kit in 7.8 oz bag, UPC code 0 71279 40701 2. Recall # F-2598-2010;
 
12) Fresh Express Gourmet Cafe Chop Turkey Chef kit in 9.1 oz bag, UPC code 0 71279 40702 9. Recall # F-2599-2010;
 
13) Fresh Express Gourmet Cafe Tuscan Chicken Pesto kit in 7.8 oz bag, UPC code 0 71279 40706 7. Recall # F-2600-2010;
 
14) Fresh Express Green & Crisp kit in 12 oz bag, UPC code 0 71279 10804 9. Recall # F-2601-2010;
 
15) Fresh Express Hearts of Romaine in 10 oz bag, UPC code 0 71279 26102 7, and in 18 oz bag, UPC code 0 71279 26201 7. Recall # F-2602-2010;
 
16) Fresh Express Italian Mix in 10 oz bag, UPC code 0 71279 21100 8. Recall # F-2603-2010;
 
17) Fresh Express Leafy Green Romaine in 9 oz bag, UPC code 0 71279 26112 6. Recall # F-2604-2010;
 
18) Fresh Express Lettuce Trio in 9 oz bag, UPC code 0 71279 10809 4. Recall # F-2605-2010;
 
19) Fresh Express Premium Romaine in 9 oz bag, UPC code 0 71279 10808 7. Recall # F-2606-2010;
 
20) Fresh Express Romaine Chopped 6/2# in 32 oz bag, UPC code 1 71279 26100 3. Recall # F-2607-2010;
 
21) Fresh Express Triple Hearts in 8 oz bag, UPC code 0 71279 26111 9. Recall # F-2608-2010;
 
22) Fresh Express Veggie Lovers salad mix in 12 oz bag, UPC code 0 71279 28100 1. Recall # F-2609-2010
CODE
Use-by Dates of May 13th through May 16th and an S in the Product Code
RECALLING FIRM/MANUFACTURER
Fresh Express Inc., Salinas, CA, letters and press release on May 24, 2010. Firm initiated recall is ongoing.  
REASON
Product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
122711 packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
1)LFB Margarine Croissant, Breakfast Sandwich; Net Wt 11.72 lb (5.31 kg) case, 150 Count/1.25 oz croissants per case; item 4601265048. Recall # F-2610-2010;
 
2) Microwaveable Sandwich Croissants, Closed/Sliced; Net Wt 9.188 lb (5.31 kg) case, 84 Count/1.75 oz croissants per case; the croissants were sold under the following labels: a) SSA Microwaveable Sandwich Croissant, Margarine, Closed/Sliced, item 4601216306; b) LFB Microwaveable Croissant Margarine, Sandwich, Closed/Sliced, item 4601216319. Recall # F-2611-2010
CODE
1) Lot # 10140NL;
2) Lot # 10139NL
RECALLING FIRM/MANUFACTURER
Fresh Start Bakeries North America, Northlake, IL, by telephone and letters dated June 17, 2010. Firm initiated recall is ongoing.
REASON
The croissants may have pieces of pecan baked into them.
VOLUME OF PRODUCT IN COMMERCE
1,517 cases
DISTRIBUTION
IL, IN, MN, TX
___________________________________
PRODUCT   
NewStar Spinach, 2.5 lb. bags, Item code 39-10-03-01 in plastic bags, 4 bags per carton (cardboard box). Store refrigerated. Production code 11B07228. Recall # F-2612-2010
CODE
Julian Date 158 14:46  
RECALLING FIRM/MANUFACTURER
NewStar Fresh Foods, LLC, Salinas, CA, by letter and telephone in June, 2010. FDA initiated recall is ongoing.
REASON
Product tested positive for Salmonella, found by USDA MDP program.
VOLUME OF PRODUCT IN COMMERCE
480 cases
DISTRIBUTION
NY, CA, IL, UT, GA, CO, MI
___________________________________
PRODUCT   
California Chili Pods sold as: "Miravalle Chile California & Miravalle Chile Nuevo Mexico" Brands; 3oz. (UPC Code: 7 12810-00301 & 7 12810-00304), 6 oz. (UPC Code: 7 12810-60001 & 7 1280-60004), 8oz. (UPC Code: 7 12810-00802 & 7 12810-00803) and 16 oz. (UPC Code: 7 12810-16005 & 7 12810-16007); Bulk 25lb. units that can be identified by "California/New Mexico" Bulk Peppers. Recall # F-2613-2010
CODE
No lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Miravalle Foods, South El Monte, CA, letter on June 24, 2010 and press release on July 8, 2010.  
Manufacturer: INKA'S HANDCRAFT E.I.R.L, Paramonga, Peru. FDA initiated recall is ongoing.
REASON
The recall was initiated because the affected Peppers have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
39,825 lbs
DISTRIBUTION
CA, CO, ID, NE, NC, NV, OR, UT, VA
___________________________________
PRODUCT   
Ready Pac Baby Spinach, Spinach Temptations, 6 oz. bag (6 units/case), UPC Code: 77745 20676. Recall # F-2614-2010
CODE
Code date IR127121 with additional coding of 1707B and a Use by date of July 4, 2010; Code date IR130373 with additional coding of 2007B and a Use by date of July 8, 2010
RECALLING FIRM/MANUFACTURER
Ready Pac Foods Inc., Irwindale, CA, e-mail on July 6, 2010, and by letter and press release on July 7, 2010. FDA initiated recall is ongoing.
REASON
The recall was initiated because the affected Ready Pac Baby Spinach product may be contaminated with Escherichia coli O157:H7 bacteria.
VOLUME OF PRODUCT IN COMMERCE
4212 units (702 cases)
DISTRIBUTION
CA, WA, AZ
___________________________________
PRODUCT   
Organicgirl Baby Spinach in 10 oz packages, sold by organicgirl produce.  Product code 11A061167. Recall # F-2615-2010
CODE
Use by date of May 22  
RECALLING FIRM/MANUFACTURER
NewStar Fresh Foods, LLC, Salinas, CA, press release on May 27, 2010. FDA initiated recall is ongoing.
REASON
Product may be contaminated with salmonella. Positive sample found through random retail sample through IEH.
VOLUME OF PRODUCT IN COMMERCE
4,214 units (702 cases)
DISTRIBUTION
AL, NC, OR, WI, AZ, CA
___________________________________
PRODUCT   
1) Setton Farms brand Total Energy Mix, Net Wt. 22 oz. (624g), UPC 34325 03559 and 2) Fairway brand Energy Mix, Net Wt. 16 oz. (454g) , UPC 34325 00050. The trail mix products were packaged in clear plastic containers. Recall # F-2616-2010
CODE
Expiration date 06/3/11; expiration dates of 05/24/11 through 06/28/11
RECALLING FIRM/MANUFACTURER
Setton International Foods, Inc., Commack, NY, by press release on July 2, 2010. Firm initiated recall is ongoing.
REASON
The products may contain peanuts, a known allergen, and chocolate flavored chips (Sugar, Partially Hydrogenated Palm Kernel Oil, Cocoa, Cocoa Processed with Alkali, Sorbitan Monosterate (An Emulsifier), Salt, Soy Lecithin (An Emulsifier), Vanillin (An Artificial Flavor)) not listed on the label.
VOLUME OF PRODUCT IN COMMERCE
1) 33 cases; 2) 15 cases
DISTRIBUTION
NY, NJ
___________________________________
PRODUCT   
Spinach, Fresh, packaged in 8 ounce, 10 ounce and 12 ounce cellophane bags, under the Lancaster, Krisp-Pak, Giant, and America's Choice labels. UPC 3338365201, 1305501145, 8826709813, and 5480776060. Recall # F-2617-2010
CODE
Best Enjoyed by 19 JUN 10 thru 27 JUN 10
RECALLING FIRM/MANUFACTURER
Lancaster Foods, Jessup, MD, by e-mail and letter on June 23, 2010 and by press release on June 24, 2010. North Carolina initiated recall is ongoing.
REASON
Fresh spinach may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
7605 cases
DISTRIBUTION
NC, MD, VA, PA, DE, NJ
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT   
Garlic spread - Ready to Use. Product is packaged in 7 oz. plastic clear jars with red cap. Label is red, white, yellow, black, green and blue with red, yellow & black, white black and blue writing on it. Further packaged into master cartons which contain six (6), 7 ounce jars/case. Recall # F-2582-210;
CODE
1) Lot # 92641, Lot # 93021, Lot # 93291, Lot #100391, Lot #101181
RECALLING FIRM/MANUFACTURER
Soup Bases Loaded, Ontario, CA, by visit beginning June 25, 2010. Firm initiated recall is ongoing.
REASON
This recall has been initiated due to non- declared allergens Milk and Wheat ingredients on label. Consumption of this product may include potential allergenic health hazards.
VOLUME OF PRODUCT IN COMMERCE
3,176 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
1) Amish Wedding Naturally Good All Natural Old Fashioned Sweet Potato Butter, 18 oz glass jar, UPC 0 49646 65550 2, Item #1237. Refrigerate after opening; Item #, 6882, Old Fashioned Sweet Potato Butter, 12/18 oz. (510g) jar, UPC 0 49646 65550 2, Ingredients: Sweet potatoes, sugar, water, spices, vanilla, Refrigerate after opening. Sold under the following labels: Lonesome Dove Bison & Guest Ranch; Klemke's Sausage Haus & Bar-B-Q Joints; Item #, 7728, Old Fashioned Sweet Potato Butter, 12/18 oz. (510g) glass jar, UPC 0 49646 65550 2, Ingredients: Sweet potatoes, sugar, water, spices, vanilla, Refrigerate after opening. Sold under the following labels: Rocky Mountain Pantry; House of Carter; Boggio's Little Mtn. Orchard; Riley's Gifts and More; Horrocks Farm Market; Stubbys Inc.; Great Specialty Products; Holden Brothers Produce; Ashe County Cheese; Shaffer's Market; Kerr Farms & Market; Amish Cheese House; Historic Round Barn; Fisher's Country Store; Abbott Farms; The Farm Store; Amish Farms; Gruene Haus; Gruene General Store; Klemke's Sausage Haus & Bar-B-Q Joints; and Old Fashioned Sweet Potato Butter 12/16 OZ. (454g), UPC 0 49646 65550 2 Graves Farm & Garden. Recall # F-2584-2010;
 
2)Amish Wedding Naturally Good All Natural Old Fashioned Pumpkin Butter, 9 oz glass jar, UPC 0 49646 500014 7, Item #1239 & 18 oz glass jar, UPC 0 49646 65549 2, Item #1240.  Refrigerate after opening. Item #, 7724, Old Fashioned Pumpkin Butter, 12/9 OZ. (226ml) glass jar, UPC 0 49646 65549 6, Ingredients: Pumpkin, Sugar, Lemon Juice or Citric Acid, Spices. Refrigerate after opening. Sold under the following labels: Brumfield Farm Market; Goldie's Front Porch Inc; Horrocks Farm Market; Swiss Meat & Sausage Company; Nostalgic Mercantile; Moose Mercantile; Planktown Country Market and Item #, 7726, Old Fashioned Pumpkin Butter, 12/18 oz. (532ml) glass jar, UPC 0 49646 65549 6, Ingredients: Pumpkin, Sugar, Lemon Juice or Citric Acid, Spices., Refrigerate after opening. Sold under the following labels: Apple Barn; Wilson's Farm; Graves Farm & Garden; Dutch Pantry; Country Creations; Aunt Ninnies Kitchen & Gifts; Millburn Orchards; Horrocks Farm Market; Weaver's Country Market; Sauders Store Inc.; Brights Nursery; Hattie's Cafe & Gifts; Granny's Oven Fresh; Apple Castle; YODERS GIFTS SHOP; MMKM Family Produce; Cagle Foods; Damascus General Store. Recall # F-2585-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Amish Wedding Foods Inc., Millersburg, OH, by letter on May 11, 2010. FDA initiated recall is ongoing.
REASON
Products under recall contain low acid ingredients. The products are not acidified or manufactured with a process that ensures safety. Analysis of samples collected by FDA found water activity >0.85 and pH >4.6. Possible risk of Clostridium botulinum toxin.
VOLUME OF PRODUCT IN COMMERCE
6320 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Product is a spinach, cheese, and artichoke dip that is sold frozen and intended to be micro waved prior to eating. Product is packaged in microwaveable trays with a film covering. The Dip is marketed under "Stop & Shop" brand is packaged in the 8 oz tray with a plastic seal over the tray and there are 12 trays per case. The product's label reads in part: "Dip Spinach & Artichoke***Net Wt 8 oz***KEEP FROZEN-COOK THOROUGHLY***INGREDIENTS: SPINACH, ARTICHOKE WITH JUICE***CREAM CHEESE***UPC 688276 029882". The Dip is marketed under "COOPER'S" brand is packaged in the 8 oz tray and there are 4 trays per case. Cooper's label reads in part: "COOPER'S Spinach, Cheese & Artichoke Dip***Net Wt 8 oz***KEEP FROZEN COOK THOROUGHLY***INGREDIENTS: SPINACH, ARTICHOKE***CREAM CHEESE*** UPC 041498 168230". Recall # F-2586-2010
CODE
On the retail packages, either a code "ML3091B Best by Jun 30, 2011" or "NC0202B Best by Sept 02, 2011" is observed. On the master cases of Stop N Shop brand, one of these codes NK309, NL309, or NA220 is observed. On the master cases of COOPER'S brand, one of these codes NA150, NA200, NA260, NA300, NB030, NB060, or NB260 is observed.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Great American Appetizers, Inc., Nampa, ID, by letter on April 16, 2010.
Manufacturer: Food Source, L, McKinney, TX. Firm initiated recall is ongoing.
REASON
Spinach, Cheese and Artichoke Dip have tested positive for Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
1350 cases of Stop N Shop brand and 6480cases of COOPER'S brand.
DISTRIBUTION
Unknown
___________________________________
PRODUCT   
Family Pantry, Jumbo Marshmallows, Net Wt 10 oz (284g), Product of Mexico. SKU #1203112, UPC: 876941003901. Recall # F-2587-2010
CODE
Lot numbers: 33209 and 07610  
RECALLING FIRM/MANUFACTURER
Recalling Firm: Family Dollar Services Inc., Charlotte, NC, email on June 7, 2010. 
Manufacturer: Grupo Industrial Michel, Zapopan, Jalisco, Mexico. Firm initiated recall is ongoing.
REASON
Product may contain metal fragments.
VOLUME OF PRODUCT IN COMMERCE
20,736 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Cheese Cake-Plain 40 oz. (1.2 kg), Ingredients: Cream cheese (Cream, Skin Milk, Proteins, Salt, Xanthan, Locust Bean, Guar Gum) Sour Cream (Cream, Potassium Sorbate, Rennin) Sugar, Eggs, Flour, Pectin, Graham Cracker (Flour, Riboflavin, Corn Syrup, Graham Flour, Vegetable Shortening, Salt, Honey). Contains: Milk, Eggs. The frozen plain cheesecake is 9 inch, (40 oz), and is individually packaged in aluminum trays. The aluminum trays are topped with thin piece of cardboard. The pies are packaged 6 pies to a cardboard box. Recall # F-2619-2010
CODE
Lot numbers 0344 and 0313
RECALLING FIRM/MANUFACTURER
F.A.R Pie Times, Inc., Miami Springs, FL, by letter March 30, 2010. FDA initiated recall is complete.
REASON
The honey gram crumbs used in the cheesecakes crust declare wheat within their ingredient labeling. However, wheat was inadvertently left off the ingredient statement on the finished cheesecake labeling.
VOLUME OF PRODUCT IN COMMERCE
112 cases
DISTRIBUTION
FL
___________________________________
PRODUCT   
York Pieces Peppermint Flavored Dark Chocolate in 5 oz, 12 bags/case; Item # 34000-11435-000. Recall # F-2620-2010
CODE
Case Code: 27F, 27G, 27N, 27P, 27R, 28E, 28G; Best Before: Jun 11  
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hershey Intl, Hershey, PA, by telephone and/or email on July 1-2, 2010.
Manufacturer: Biscomerica, Inc., Rialto, CA. Firm initiated recall is ongoing.
REASON
Candy may contain small metal pieces.
VOLUME OF PRODUCT IN COMMERCE
4,685 cases
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
California Roll, Surimi and Seasonings, Avocado, Wrapped with Seaweed and Rice. Product is packed 15 rolls in a clear cello pack (no labeling), 8 pkgs/case. Cases labeled Sushi BAR by Golden Tiger California Roll 57323 Contains: Fish (Pollock), Shell Fish (Crab), Wheat, Eggs, Soy, Net Wt .625 lbs. UPC 10076366573233. Recall # F-2572-2010
CODE
Unit: 7110117A
RECALLING FIRM/MANUFACTURER
Curveset, LLC, dba Banzai Sushi, Seattle, WA, by telephone on June 10, 2010, followed with a letter dated June 18, 2010. Firm initiated recall is ongoing.
REASON
Some packages actually contained a different product, Vegetarian Rolls. There were no undeclared allergens.
VOLUME OF PRODUCT IN COMMERCE
Vegetarian Roll - 768 cases; California Roll - 896 cases
DISTRIBUTION
Unknown
___________________________________
PRODUCT   
Product is dietary supplement, packaged 60 vegetarian capsules per bottle. Bottle and carton's labeled in part: "SUPER ECHINACEA***Root, Leaf, Flower & Seed***Supports Healthy Function of the Immune System***350 mg each, UPC9070000396". Recall # F-2618-2010
CODE
5152 (07/11) and 6358 (03/13)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Herb Pharm, Williams, OR, by letter on June 30, 2010.
Manufacturer: ProPac Laboratories, Inc., Ogden, UT. Firm initiated recall is ongoing.
REASON
The Herb Pharm Super Echinacea dietary supplement is mislabeled. The dosage instructions on the bottle's label do not match the dosage instructions on the product's outer retail carton.
VOLUME OF PRODUCT IN COMMERCE
9324/60 cap. Bottles Total (Lot #5152: 9182 Bo+ Lot #6358: 142 Bo)
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
1) Amoxicillin for Oral Suspension, USP, 400 mg/5 mL, 100 mL (when reconstituted) bottle, Rx only; NDC 0093-4161-73. Recall # D-701-2010;
 
2) Amoxicillin and Clavulanate Potassium For Oral Suspension USP, 600 mg/42.9 mg per 5 mL, 75 mL (when reconstituted) bottle, Rx only; NDC 0093-8675-78. Recall # D-702-2010;
 
3) Penicillin V Potassium for Oral Suspension, USP, 250 mg (400,000 U) per 5 mL, 100 mL (when reconstituted) bottle, Rx only; NDC 0093-4127-73. Recall # D-703-2010
CODE
1) Lot 35409398A, Exp 07/10; Lot 35410920A, Exp 11/10; Lot 35411610B, Exp 01/11;
2) Lot 35412741A, Exp 06/10;
3) Lot 418824A, Exp 06/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on May 25, 2010 and May 26, 2010.  
Manufacturer: Novopharm Limited, Ontario, Canada. Firm initiated recall is ongoing.
REASON
Subpotent (Single Ingredient) Drug: Some bottles may not meet fill weight specifications.
VOLUME OF PRODUCT IN COMMERCE
131,882 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Oxygen, Compressed, USP in M6 and E cylinders. Recall # D-714-2010
CODE
All codes before 042010
RECALLING FIRM/MANUFACTURER
Jayhawk Pharmacy and Patient Supply, Topeka, KS, by visits on April 21, 2010 and telephone and visits beginning April 26, 2010. Firm initiated recall is complete.
REASON
Lack of conformance with GMP's (including but limited to failure to perform assay testing on each manifold filling sequence, failure to properly calibrate gas analyzer).
VOLUME OF PRODUCT IN COMMERCE
Approximately 580 cylinders
DISTRIBUTION
KS
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Wellbutrin XL (buproprion Hydrochloride Extended Release Tablets) 150 mg, 90 tablets,  
NDC: 64455-730-90. Recall # D-710-2010
CODE
Lot number 10C094P, Exp July 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: BTA Pharmaceuticals Inc., Bridgewater, NJ, by letters on July 16, 2010.
Manufacturer: Biovail Corp., Manitoba, Canada. Firm initiated recall is ongoing.
REASON
Wellbutrin XL, 150 mg extended release tablets are being recalled because the dissolution release rate is below specification for two tablets at the four hour time point.
VOLUME OF PRODUCT IN COMMERCE
12,981 bottles of 90 count
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Sani Pads, 100 Pre-Moistened Hemorrhoidal/Vaginal Pads. Also packaged as Rexall Hygienic Cleansing Pads, 50 Count; Manufactured for: Rexall Brands; and Publix Hygienic Cleansing Pads, 100 count. 100 count NDC 0713-0308-98; 50 Count NDC # 0713-0308-42. Recall # D-713-2010
CODE
Lot # 030808020, Exp 9/2010
RECALLING FIRM/MANUFACTURER
G & W Laboratories, Inc., South Plainfield, NJ, by letters on May 17, 2010. Firm initiated recall is ongoing.
REASON
Product Lacks Stability: The 18 month room temperature stability alcohol assay value failed to meet specifications.
VOLUME OF PRODUCT IN COMMERCE
7,872 jars of 100, 2,976 jars of 50
DISTRIBUTION
Nationwide and Canada
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1298-10;
2) Plasma Frozen within 24 hours (FP24). Recall # B-1299-10
CODE
1) and 2) Unit: 06LT66204
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by fax on November 9, 2009 and letters dated November 6, 2009 and February 16, 2010. 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
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1732-10
CODE
Units: 4100346948, 4100345774, 4100326145, 4100324636, 4100323765, 4100322366, 4100321489, 4100316982, 4100312768, 4100311765, 4100310250, 4100309242, 4100307850, 4100305690, 4100304343
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Kansas City, MO, by letter on November 10, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
IL, Switzerland
___________________________________
PRODUCT
Source Plasma. Recall # B-1741-10
CODE
Units: 4080365458, 4080364811, 4080362735, 4080361373, 4080360702, 4080359659, 4080359014, 4080355379, 4080354780, 4080353011, 4080352374, 4080351110, 4080350445, 4080349110, 4080348412, 4080346556, 4080345959, 4080344493, 4080343922, 4080321012, 4080320307, 4080317105, 4080314356, 4080312397, 4080311128, 4080268654, 4080267944
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL, by letter on September 23, 2009.
Manufacturer: ZLB Bioplasma, Inc., Dayton, OH. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Source Plasma. Recall # B-1751-10
CODE
Units: 4940074276, 4940073715, 4940071471, 4940069659, 4940069033, 4940067949, 4940067284, 4940066697, 4940066186, 4940065501, 4940065059, 4940064400, 4940063689, 4940063201, 4940062301, 4940061045, 4940060118, 4940059432, 4940058612, 4940058035, 4940057327, 4940056944, 4940056102, 4940055531, 4940054916, 4940054377, 4940053585, 4940053352, 4940052476, 4940052053, 4940049911, 4940049641, 4940049033, 4940048708, 4940048167, 4940047623, 4940047193, 4940046601, 4940042440, 4940041959, 4940041499, 4940041081, 4940040644, 4940040281, 4940039741, 4940039321, 4940038905, 4940038496, 4940038086, 4940037701, 4940037068, 4940036329, 4940035745, 4940035507, 4940034949, 4940034585, 4940034066, 4940033784, 4940033321, 4940032928, 4940032509, 4940031829, 4940031581, 4940031046, 4940030789, 4940030315, 4940030001, 4940029514, 4940029296, 4940028529, 4940021502, 4940021131, 4940020946, 4940020482, 4940020217, 4940019234, 4940016753, 4940016190, 4940014889, 4940014693, 4940014270, 4940013994, 4940013711, 4940013405, 4940013024, 4940012532, 4940012060, 4940011866, 4940011351, 4940011205, 4940010801, 4940010451, 4940010120, 4940009762, 4940009437, 4940009264, 4940008972, 4940008801, 4940008451, 4940008262, 4940007933, 4940007763, 4940007371, 4940007289, 4940006944, 4940006904, 4940006543, 4940004253, 4940003913, 4940003525, 4940003400, 4940003161, 4940003016, 4940002791, 4940002646, 4940002380, 4940002307, 4940001986, 4940001797, 4940001533, 4940000538, 4940000373
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Plasma Inc., Boca Raton, FL, by fax on April 22, 2008. 
Manufacturer: ZLB Plasma Inc., Hamilton, OH. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
122 units
DISTRIBUTION
IL, NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1770-10
CODE
Unit: 72N778904
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by facsimile on May 12, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1814-10
CODE
Unit: W036810029994
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S Florida, Inc., Lauderhill, FL, by telephone on March 19, 2010. Firm initiated recall is complete.
REASON
Blood product, which did not meet the minimum requirement for volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Source Plasma. Recall # B-1872-10
CODE
Units: 0421346658, 0421345859, 0421342226, 0421340554, 0421336415, 0421335664, 0421330662, 0421324454, 0421329725, 0421305734, 0421288372, 0421287707
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Lansing, MI, by letter and email on March 12, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
IL, Switzerland
___________________________________
PRODUCT
1) Platelets. Recall # B-1889-10;
2) Fresh Frozen Plasma. Recall # B-1890-10
CODE
1) and 2) Unit: 13G23613
RECALLING FIRM/MANUFACTURER
American Red Cross Southeastern Michigan Region, Detroit, MI, by fax and letter dated March 4, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was incorrectly removed from the deferral list, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Source Plasma. Recall # B-1891-10
CODE
Unit: 09BWAC1079
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Bellingham, WA, by facsimile on February 9, 2010. 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
1) Red Blood Cells Leukocytes Reduced. Recall # B-1893-10;
2) Plasma Frozen within 24 hours. Recall # B-1894-10
CODE
1) and 2) Unit: 16GQ44737
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Central Ohio Region, Columbus, OH, by telephone on September 29, 2008 and follow-up letter on October 2, 2008.
Manufacturer: American Red Cross Blood Services, Central Ohio Region, Columbus, OH. 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
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Source Plasma. Recall # B-1895-10
CODE
Units: 0111144734, 0111140365, 0111136155, 0111134821
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Kansas City, MO, by letter on March 6, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Switzerland, Germany, IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1896-10
CODE
Unit: W045010003920
RECALLING FIRM/MANUFACTURER
Community Blood Center Of Greater Kansas City, Kansas City, MO, by letter on February 23, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MO
___________________________________
PRODUCT
Source Plasma. Recall # B-1897-10
CODE
Units: 0650403451, 0650402955, 0650401898, 0650401451, 8810005858, 8810004873, 8810004282, 8810003727, 8810003251
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Racine, WI, by letter, fax and email on July 17, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
IL, NC, Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1898-10
CODE
Unit: W044609343932
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by fax on March 25, 2010. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with air during collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1899-10
CODE
Unit: W043210006492
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by telephone on March 31, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Source Plasma. Recall # B-1900-10
CODE
Units: 0540576929, 0540574893, 0540572893, 0540571893, 0540571386, 0540570556, 054570036, 0540569019, 0540568635
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Louisville, KY, by letter and email on March 27, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
IL, Germany, Switzerland
___________________________________
PRODUCT
Source Plasma. Recall # B-1901-10
CODE
Units: 4270245470, 4270241955, 4270241188, 4270238441, 4270236868, 4270235846, 4270233934, 4270232884, 4270231591
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Tempe, AZ, by letter and email on April 14, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Source Plasma. Recall # B-1902-10
CODE
Units: 0540713409, 0540711578, 0540707569, 0540707006, 0540705994, 0540705470, 0540703963, 0540703432, 0540702082, 0540701545
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Louisville, KY, by letter on May 1, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
IL, Germany
___________________________________
PRODUCT
Source Plasma. Recall # B-1903-10
CODE
Units: 0481147995, 0481146363, 0481144817, 0481142886, 0481139694
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Tempe, AZ, by letter and email on January 20, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
IL, Switzerland
___________________________________
PRODUCT
Source Plasma. Recall # B-1904-10
CODE
Units: 0650403022, 0650401835, 8810005224, 8810004942, 8810004022, 0650397482, 0650396818, 0650396635, 0650395957, 0650395438, 0650395210, 0650394215, 0650393887, 0650393252, 0650392860 
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Racine, WI, by letter on July 17, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
IL, NC, Germany
___________________________________
PRODUCT
Source Plasma. Recall # B-1906-10
CODE
Units: 6030210719, 6030209404, 6030203742, 6030203048, 6030202521, 6030201479, 6030200371, 6030199643, 6030186837, 6030186332, 6030184263, 6030181109, 603018052, 6030173481, 6030171742
RECALLING FIRM/MANUFACTURER
ZLB Plasma, Corpus Christi, TX, by fax on January 11, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1907-10
CODE
Units: 4940059986, 4940055086, 4940054092, 4940053699, 94CYGYGG, 94CYGXQJ, 94CYGXKQ, 94CYGXDQ, 94CYDZFD
RECALLING FIRM/MANUFACTURER
ZLB Plasma, Hamilton, OH, by letter on February 3, 2010 and by email on March 2, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
IL, Germany
___________________________________
PRODUCT
Source Plasma. Recall # B-1908-10
CODE
Units: 37745639, 37741082, 37731304, 37721893, 3771712, 37712044, 37708542
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Portland, OR, by letter on April 15, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously indefinitely deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
IL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1911-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1912-10
CODE
1) Units: 5003457; 2506969;
2) Units: 3504641; 7000923
RECALLING FIRM/MANUFACTURER
Upstate New York Transplant Services, Inc., Buffalo, NY, by telephone on January 8, 2010 and fax on January 11, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from donors who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1934-10
CODE
Unit: 024FC58921
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, River Valley Region, Louisville, KY, by facsimile and electronic notification on February 24, 2010 and by letter dated March 31, 2010. 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
KY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1936-10
CODE
Unit: 72N967973
RECALLING FIRM/MANUFACTURER
Lifesouth Community Blood Centers - Montgomery Region, Montgomery, AL, by facsimile on May 12, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1938-10;
2) Plasma Frozen. Recall # B-1939-10
CODE
1) Units: W065610006874, W065610009342;
2) Unit: W065610009342
RECALLING FIRM/MANUFACTURER
Bergen Comm Reg Blood Center, Paramus, NJ, by telephone on April 27, 2010 and by facsimile on April 28, 2010. Firm initiated recall is complete.
REASON
Blood products, which tested positive for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NY, NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1940-10
CODE
Unit: W227709342197
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by facsimile on March 5, 2010 and by telephone on April 1, 2010. 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
TN
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1943-10;
2) Recovered Plasma. Recall # B-1944-10
CODE
1) and 2) Units: W044410200453, W044409201007
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank dba Rock River Valley BC, Rockford, IL, by facsimile on April 13, 2010 and by letter dated April 19, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of exposure to hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
IL, Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-1945-10
CODE
Unit: 09ATXJ9539
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Austin, TX, by facsimile on March 4, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of incarceration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-1946-10
CODE
Units: 0411510512, 0411494089, 0411493111, 0411487254, 0411486786, 0411485111, 0411511091, 0411484255, 0411475329, 0411474168, 0411472709, 0411471793, 0411470424
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Oak Park, MI, by facsimile on April 8, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have an annual physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
Germany, NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1947-10
CODE
Unit: 10MIDA0755
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Ammon, ID, by facsimile on April 27, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have an annual physical examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-1948-10;
2) Platelets. Recall # B-1949-10;
3) Red Blood Cells Leukocytes Reduced. Recall # B-1950-10;
4) Recovered Plasma. Recall # B-1951-10
CODE
1) Unit: 7214599;
2) Unit: 7214599;
3) Units: 7311151, 7214599, W091009100116
4) Units: 7214599, W091009100116
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by facsimile on March 19, 2010, March 23, 2010, March 26, 2010, and April 6, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from donors who were deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
TX, OK, IN, NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1952-10
CODE
Unit: W165710008698Y
RECALLING FIRM/MANUFACTURER
Our Lady Of The Lake Hospital Inc., Attn Blood Bank, Baton Rouge, LA, by telephone and facsimile on April 28, 2010. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving post-donation information from the donor regarding a history of high risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1953-10
CODE
Unit: 4169621
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida's Blood Centers - Lake Park, Lake Park, FL, by letter dated March 19, 2010.
Manufacturer: Florida's Blood Centers, Inc. - Pt. St. Lucie, Port St Lucie, FL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously permanently deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1954-10;
2) Recovered Plasma. Recall # B-1955-10
CODE
1) and 2) Unit: W044609486104
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by fax on March 29, 2010; March 31, 2010 and April 2, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ, KY
___________________________________
PRODUCT
Source Plasma. Recall # B-1956-10
CODE
Units: 6110082020; 6110088303; 6110087666; 6110087223; 6110086423; 6110086049; 6110084956
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Baton Rouge, LA, via the internet on March 10, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Source Plasma. Recall # B-1957-10
CODE
Units: 4080305580; 4080304820
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Dayton, OH, via the internet on December 14, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1958-10
CODE
Unit: 011KC46089
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by fax on March 12, 2010 and the LOGICS system on April 1, 2010. 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
MO  
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1960-10
CODE
Units: W071909006471; W071909002746; W071909005521
RECALLING FIRM/MANUFACTURER
So California Permanente Med Group Blood Donor Center, Los Angeles, CA, by telephone on January 8, 2010 and e-mail and letter on January 11, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria and leishmaniasis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1961-10
CODE
Unit: W053309606694
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by letter dated January 12, 2010 and telephone on February 10, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who may have travelled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1962-10;
2) Platelets Pooled Leukocytes Reduced. Recall # B-1963-10
CODE
1) Unit: W120610001120;
2) Unit: W120610180440
RECALLING FIRM/MANUFACTURER
Michigan Blood, Grand Rapids, MI, by fax on March 29, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1965-10
CODE
Units: W053309941080; W053309941086; W053309941089; W053310820040; W053310820045; W053310820046; W053310820047
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by telephone on February 2, 2010. Firm initiated recall is complete.
REASON
Blood products, tested for syphilis using expired reagents, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
WI
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1702-10
CODE
Units: 03LS45272; 03LS45054; 03LS45058; 03LS45169; 03LS45061; 03LS45055; 03LS45062; 03LS45267
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by telephone on August 17, 2007 and by letter on September 4, 2007 and on October 9, 2007. Firm initiated recall is complete.
REASON
Blood products, collected using equipment that had not been validated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
AL, GA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1703-10
CODE
W270108201164, W270108201165, W270108201229, W270108202332, W270108202334, W270108202335, W270108202337, W270108202340, W270108202353, W270108202775, W270108202807, W270108202809, W270108202813, W270108202815, W270108202816, W270108202818, W270108206863, W270108206910, W270108206918, W270108206920, W270108206922, W270108206923, W270108206927, W270108206931, W270108206932, W270108206949, W270108207612, W270108208795, W270108301313, W270108301314, W270108301315, W270108301347, W270108302608, W270108302609, W270108302610, W270108302611, W270108302612, W270108302613, W270108302614, W270108302615, W270108302617, W270108302618, W270108302619, W270108302620, W270108302621, W270108302622, W270108302623, W270108302624, W270108302627, W270108302628, W270108302629, W270108302632, W270108302633, W270108302635, W270108302636, W270108302637, W270108302638, W270108303236, W270108303261, W270108303266, W270108305201, W270108402661, W270108501809, W270108504912, W270108505460, W270108512654, W270109200831, W270109200838, W270109201956, W270109201957, W270109201965, W270109201967, W270109202536, W270109202947, W270109202971, W270109203548, W270109203551, W270109203648, W270109203751, W270109203752, W270109203753, W270109203754, W270109203755, W270109203756, W270109203762, W270109203764, W270109204425, W270109204426, W270109204427, W270109204428, W270109204429, W270109204430, W270109204432, W270109204433, W270109204464, W270109300689, W270109300745, W270109301621, W270109301622, W270109301623, W270109301929, W270109303206, W270109303207, W270109303218, W270109303223, W270109303233, W270109303268, W270109307289, W270109307378, W270109307537, W270109307538, W270109307541, W270109307543, W270109307544, W270109307545, W270109307546, W270109307547, W270109307549, W270109307556, W270109307557, W270109307578, W270109307796, W270109307829, W270109307906, W270109307907, W270109307908, W270109307911, W270109307912, W270109308247, W270109308414, W270109500400, W270109501496, W270109505667, W270109506122, W270109506424, W270109506481, W270109507561, W270109507724, W270109508398, W270109509328, W270109509332, W270109509333, W270109510979, W270109510981, W270109510983, W270109510985, W270109510986, W270109510988, W270109510989, W270109510990, W270109510991, W270109510993, W270109510994, W270109510995, W270109510996, W270109510997, W270109511001, W270109511103, W270109511455, W270109511650, W270109512546, W270109512552, W270109512773, W270109513132, W270109513253, W270109513266, W270109513454, W270109513771, W270109514371, W270109514377, W270109515040, W270109515160, W270109515164, W270109515170, W270109515187, W270109515193, W270109515209, W270109515210, W270109515212, W270109515213, W270109515215, W270109515216, W270109515217, W270109515218, W270109515221, W270109515224, W270109515233, W270109515240, W270109515242, W270109515245, W270109515246, W270109515368, W270109515370, W270109515375, W270109516258, W270109516265, W270109519372, W270109519816, W270109519817, W270109519820
RECALLING FIRM/MANUFACTURER
Central Pennsylvania Blood Bank, Hummelstown, PA, by letter on June 4, 2009. Firm initiated recall is complete.
REASON
Blood products, manufactured without additive solution, were distributed.
VOLUME OF PRODUCT IN COMMERCE
200 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Source Plasma. Recall # B-1706-10
CODE
Unit: AQ030449
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plasma Biological Services, Inc. Memphis, TN by fax on October 2, 2007. 
Manufacturer: Plasma Biological Services, Asheville, NC. 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
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1866-10
CODE
Unit: W036510045923
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by fax on April 7, 2010. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably low red cell recovery rate, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Washed. Recall # B-1892-10
CODE
Unit: 032GX15676
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by facsimile on June 13, 2008. Firm initiated recall is complete.
REASON
Blood product, which was below the acceptable limit for red cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1935-10
CODE
Unit: 024FC58921
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, River Valley Region, Louisville, KY, by facsimile and electronic notification on February 24, 2010 and by letter dated March 31, 2010. 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
Red Blood Cells Leukocytes Reduced. Recall # B-1941-10
CODE
Unit: W035810104804
RECALLING FIRM/MANUFACTURER
BloodSource, Chico, CA, by telephone on April 15, 2010. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving post donation information concerning an illness following donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1959-10
CODE
Unit: 011KC46089
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by fax on March 12, 2010 and the LOGICS system on April 1, 2010. 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
MO
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1966-10
CODE
Units: W12701080842300; W12701080842300 (split product)
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center, Tallahassee, FL, by telephone on April 15, 2010 and fax on April 16, 2010. Firm initiated recall is complete.
REASON
Blood product, with insufficient red cell preservative solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
1) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-A-HC-PERC8, G12403. Recall # Z-2076-2010;
 
2) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-A-HC-PERC8, G12566. Recall # Z-2077-2010;
 
3) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-HC-PERC6, G13165. Recall # Z-2078-2010;
 
4) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-HC-PERC6-CA, G36037. Recall # Z-2079-2010;
 
5) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-HC-PERC6, G13166. Recall # Z-2080-2010;
 
6) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-HC-PERC8, G12523. Recall # Z-2081-2010;
 
7) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-HC-PERC8-CA, G36038. Recall # Z-2082-2010;
 
8) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-HC-PERC8, G12565. Recall # Z-2083-2010;
 
9) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-HC-G-PERC6, G53178. Recall # Z-2084-2010;
 
10) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-WCE-HC-G-PERC6, G53169. Recall # Z-2085-2010;
 
11) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-WCE-HC-G-PERC8, G53170. Recall # Z-2086-2010;
 
12) Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G36116, C-PTBS-2600-PERC6. Recall # Z-2087-2010;
 
13) Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G36118, C-PTBSY-2600-PERC6. Recall # Z-2088-2010;
 
14) Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G51971, C-PTBSYJC-2600-PERC6. Recall # Z-2089-201;
 
15) Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G36117, C-PTBS-2800-PERC8. Recall # Z-2090-2010;
 
16) Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G49507, C-PTBSY-2800-PERC8. Recall # Z-2091-2010;
 
17) Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G51972, C-PTBSYJC-2800-PERC8. Recall # Z-2092-2010
CODE
1) Units: 2353818, 2240387, 2283507, 2391559, 2272941, 2395596, 2277074, 2395598, 2251489, 2300211, 2277076, 2300213, 2304560, 2314057, 2272101, 2314055, 2330811, 2297629, 2353821, 2260715, 2255291, 2272942, 2283506, 2353819, 2395597, 2240386, 2277075, 2251488, 2254635, 2246873, 2435157, 2304561, 2314056, 2314056, 2283508, 2330810, 2297628, 2280908, 2260714, 2353820, 2413134, 2442415, 2444002, 2442416, and 2444001;
 
2) Units: 2319684, 2263514, 2300215, 2363192, 2243552, 2283515, 2313164, 2399892, 2406192, 2412295, 2288472, 2279400, 2438123, 2353029, 2239476, 2298159, 2423609, 2250514, 2418954, 2333522, 2344946, 2271315, 2372827, 2430328, 2258469, 2304564, 2319683, 2384526, 2444843, 2253910, 2430327, 2392290, 2436440, 2300214, 2372828, 2363191, 2263513, 2234957, 2258470, 2243553, 2399891, 2406191, 2438122, 2239477, 2283514, 2271316, 2288471, 2250515, 2279401, 2353028, 2333521, 2313163, 2423608, 2344947, 2304565, 2448667, 2384527, 2436439, 2448668, 2253911, 2298160, 2412296, 2472889, 2444842, and 2418953;
 
3) 2381089, 2363190, 2283511, 2446534, 2308510, 2336319, 2344944, 2246874, 2306756, 2270536, 2279399, 2376120, 2319681, 2451345, 2283509, 2458351, 2458349, 2260717, 2368617, 2252379, 2283510, 2404347, 2308511, 2336318, 2446535, 2270537, 2279398, 2252380, 2344945, 2378606, 2376119, 2244980, 2319682, 2242060, 2451346, 2244979, and 2260716;
 
4) 2321967, 2381091, 2377268, 2292855, 2358868, 2244981, 2273828, 2343912, 2253163, 2300921, 2358867, 2296276, 2260718, 2381090, 2438881, 2239475, 2281768, 2311017, 2343913, 2300920, and 2416218;
 
5) Units: 2451349, 2328599, 2455952, 2330814, 2336324, 2260563, 2320508, 2242064, 2289456, 2330816, 2301524, 2260561, 2393721, 2305091, 2316113, 2305089, 2417210, 2313166, 2343922, 2289454, 2301526, 2377273, 2336320, 2440350, 2236964, 2443067, 2328597, 2316115, 2298767, 2354683, 2285639, 2254641, 2280164, 2305087, 2336322, 2440352, 2236966, 2229876, 2364739, 2316117, 2285637, 2373622, 2280166, 2254638, 2316118, 2359778, 2382675, 2310206, 2343924, 2348175, 2451351, 2272949, 2328600, 2364737, 2298768, 2320506, 2354685, 2268131, 2272946, 2348177, 2310204, 2247510, 2247509, 2364740, 2242063, 2451347, 2447611, 2373624, 2268133, 2377274, 2247512, 2242061, 2455951, 2289453, 2348178, 2330815, 2359776, 2382673, 2447613, 2451348, 2328598, 2455953, 2330817, 2301525, 2298770, 2417209, 2313168, 2260562, 2320509, 2242065, 2305088, 2343923, 2417211, 2301527, 2377272, 2336321, 2260560, 2305090, 2359780, 2316114, 2354682, 2285638, 2280165, 2313167, 2343921, 2289455, 2336323, 2440351, 2236965, 2316116, 2285636, 2254640, 2280167, 2373623, 2313165, 2260564, 2364738, 2359779, 2373621, 2382674, 2447614, 2254642, 2343925, 2451350, 2254639, 2328601, 2272948, 2455954, 2409902, 2354684, 2280168, 2440349, 2268130, 2247511, 2247508, 2236963, 2242062, 2298769, 2461159, 2320507, 2268132, 2272947, 2348176, 2310205, 2285640, 2364741, 2320505, 2289452, 2348179, 2359777, 2268134, 2382672, 2447612, 2377275, 2310203, 2272945, 2443068, 2443070, and 2443069;
 
6) Units: 2384525, 2277078, 2246050, 2272943, 2422352, 2371765, 2330067, 2270539, 2396691, 2237464, 2343917, 2425220, 2260719, 2308512, 2422354, 2371767, 2343915, 2283513, 2425222, 2406190, 2451865, 2356117, 2304562, 2438882, 2451867, 2322721, 2253165, 2378016, 2308514, 2451868, 2390807, 2242820, 2452549, 2260721, 2361423, 2435156, 2246049, 2415124, 2266385, 2314825, 2237463, 2272944, 2384524, 2277079, 2356118, 2296996, 2330066, 2343916, 2277080, 2425221, 2422353, 2371766, 2308513, 2270538, 2343914, 2396690, 2449618, 2422355, 2322719, 2277077, 2283512, 2438883, 2451866, 2322720, 2378017, 2304563, 2242819, 2322722, 2253164, 2361422, 2246048, 2415125, 2260720, 2406189, 2435155, 2314824, 2452547, 2260722, 2266384, 2296997, 2459038, 2449617, 2266386, 2412277, and 2412276;
 
7) Units: 2301522, 2281770, 2267274, 2394496, 2377271, 2292858, 2343920, 2254636, 2343918, 2272103, 2412293, 2292857, 2278725, 2281769, 2358871, 2267273, 2330813, 2382671, 2416219, 2301523, 2394497, 2377270, 2272102, 2254637, 2377269, 2343919, 2292856, 2416221, 2278726, 2358870, 2382670, 2358869, 2330812, and 2394495;
 
8) 2412286, 2379408, 2310213, 2260709, 2266390, 2358880, 2470392, 2434376, 2474493, 2283531, 2400935, 2408419, 2348193, 2450091, 2240400, 2436979, 2277087, 2415147, 2348186, 2333529, 2249434, 2358874, 2445551, 2408422, 2392305, 2423601, 2457376, 2438888, 2343933, 2454210, 2327645, 2375443, 2323537, 2302368, 2314066, 2266388, 2420411, 2353032, 2283527, 2379419, 2450085, 2412279, 2244984, 2298162, 2404334, 2397444, 2412288, 2408430, 2434379, 2441570, 2454220, 2310215, 2294877, 2375451, 2427693, 2358882, 2420421, 2348191, 2397438, 2427689, 2400937, 2277081, 2415145, 2454207, 2358876, 2445553, 2272117, 2423603, 2457374, 2438886, 2343935, 2454212, 2408420, 2305976, 2323535, 2272115, 2314064, 2327647, 2375445, 2363200, 2438893, 2237994, 2298175, 2420413, 2353034, 2283521, 2379417, 2450087, 2249428, 2371779, 2400938, 2454222, 2310217, 2323529, 2348189, 2358879, 2235679, 2427691, 2358884, 2474497, 2294875, 2240393, 2343940, 2436980, 2445555, 2305985, 2385164, 2277083, 2302367, 2438884, 2343937, 2408426, 2392301, 2272111, 2423605, 2305974, 2314062, 2400942, 2327649, 2375447, 2363202, 2237992, 2333532, 2353036, 2283523, 2379415, 2244990, 2400940, 2298173, 2363194, 2397440, 2244988, 2457381, 2260703, 2431221, 2436974, 2358886, 2366661, 2474499, 2314058, 2423599, 2343942, 2277094, 2436982, 2240391, 2235680, 2305983, 2404344, 2254658, 2318889, 2385166, 2302365, 2343939, 2450088, 2408424, 2392303, 2272113, 2423607, 2371776, 2363204, 2237990, 2333530, 2323539, 2431213, 2404339, 2314060, 2379413, 2244992, 2281782, 2298171, 2310218, 2397442, 2415139, 2302371, 2363196, 2294878, 2385172, 2310220, 2461870, 2237982, 2397435, 2260701, 2431223, 2427684, 2436976, 2235675, 2323543, 2427695, 2366663, 2392298, 2366651, 2353041, 2277092, 2283517, 2240397, 2254643, 2343944, 2434381, 2375448, 2305981, 2404342, 2343926, 2302363, 2281779, 2454218, 2363206, 2333536, 2249423, 2310209, 2305978, 2431215, 2298169, 2371774, 2415136, 2281780, 2420419, 2314070, 2379411, 2244994, 2318893, 2302373, 2327652, 2363198, 2266399, 2283538, 2461867, 2385170, 2310222, 2434371, 2397437, 2260707, 2272107, 2427686, 2237984, 2392296, 2366653, 2353043, 2323541, 2254657, 2240395, 2254645, 2277090, 2404340, 2318885, 2277089, 2294886, 2283528, 2281777, 2408428, 2244983, 2333534, 2249421, 2260711, 2431217, 2371772, 2353039, 2415134, 2240389, 2281786, 2412291, 2379405, 2327650, 2266397, 2465590, 2318891, 2302375, 2445549, 2283536, 2423594, 2385176, 2434373, 2260705, 2371780, 2272105, 2237986, 2397431, 2450094, 2366655, 2348181, 2333524, 2436972, 2254655, 2392294, 2420409, 2254647, 2375439, 2323532, 2318887, 2294884, 2281775, 2249427, 2260713, 2431219, 2298165, 2404333, 2371770, 2415132, 2379407, 2371769, 2281784, 2266395, 2237989, 2461861, 2302377, 2385174, 2434375, 2474490, 2294872, 2283534, 2423596, 2427682, 2400932, 2397433, 2450092, 2366657, 2348183, 2333526, 2249431, 2358873, 2254653, 2277084, 2415142, 2392292, 2283518, 2240399, 2343930, 2454215, 2454209, 2327642, 2318881, 2323530, 2343928, 2266400, 2281773, 2266387, 2420414, 2415129, 2294882, 2283524, 2298167, 2415130, 2244987, 2249425, 2412287, 2379409, 2266370, 2266393, 2310210, 2327654, 2434377, 2474492, 2240401, 2283532, 2400934, 2450090, 2272109, 2254648, 2249433, 2358875, 2254651, 2277086, 2415140, 2366659, 2348185, 2333528, 2457379, 2343932, 2454217, 2327644, 2375440, 2318883, 2385168, 2305973, 2323536, 2314069, 2450082, 2281771, 2266389, 2420416, 2353031, 2294880, 2283526, 2379418, 2412278, 2244985, 2298161, 2404337, 2412289, 2281788, 2454221, 2310212, 2260708, 2431224, 2266391, 2420420, 2474494, 2294876, 2283530, 2375450, 2385178, 2427692, 2358881, 2400936, 2348192, 2415146, 2348187, 2249435, 2358877, 2445550, 2436978, 2392304, 2272114, 2423600, 2457377, 2438887, 2343934, 2454211, 2408423, 2375442, 2323534, 2302369, 2314067, 2327646, 2420410, 2353033, 2283520, 2379416, 2450084, 2249429, 2298163, 2404335, 2434378, 2310214, 2294874, 2348188, 2427690, 2358883, 2420422, 2366664, 2348190, 2397439, 2240392, 2427688, 2343941, 2302366, 2445552, 2305986, 2385165, 2277082, 2415144, 2457375, 2438885, 2343936, 2454213, 2408421, 2272116, 2423602, 2305977, 2314065, 2327648, 2375444, 2363201, 2237995, 2333533, 2353035, 2283522, 2379414, 2450086, 2400941, 2298174, 2420412, 2244989, 2363193, 2371778, 2397441, 2457382, 2400939, 2310216, 2431220, 2358878, 2436983, 2436975, 2427696, 2358885, 2474498, 2314059, 2240390, 2343943, 2277095, 2436981, 2445554, 2305984, 2404345, 2318888, 2385167, 2302364, 2343938, 2450089, 2408427, 2392300, 2272110, 2423604, 2404338, 2314063, 2371777, 2375446, 2363203, 2237993, 2333531, 2305975, 2323538, 2379412, 2244991, 2400943, 2298172, 2353037, 2363195, 2457386, 2310219, 2397443, 2415138, 2457380, 2237983, 2397434, 2260702, 2431222, 2427685, 2436977, 2427694, 2358887, 2366660, 2392299, 2423598, 2277093, 2240396, 2235681, 2434380, 2375449, 2305982, 2404343, 2343927, 2302362, 2408425, 2392302, 2272112, 2423606, 2363205, 2237991, 2310208, 2431212, 2298168, 2314061, 2371775, 2281783, 2298170, 2314071, 2294888, 2379410, 2244993, 2318894, 2302370, 2327653, 2363197, 2266398, 2294879, 2385173, 2310221, 2237985, 2397436, 2260700, 2272106, 2427687, 2254656, 2366662, 2392297, 2366652, 2353040, 2436971, 2323542, 2283516, 2240394, 2277091, 2305980, 2404341, 2318884, 2277088, 2434382, 2294887, 2454219, 2281778, 2363207, 2333535, 2249422, 2305979, 2260710, 2431214, 2371773, 2353038, 2415137, 2281781, 2420418, 2412290, 2244995, 2302372, 2327651, 2363199, 2266396, 2465591, 2318892, 2283537, 2423595, 2461866, 2385171, 2434370, 2260706, 2272104, 2427681, 2237987, 2392295, 2366654, 2348180, 2333523, 2353042, 2436973, 2323540, 2254654, 2254644, 2375438, 2318886, 2310207, 2294885, 2283529, 2281776, 2408429, 2244982, 2249420, 2260712, 2431216, 2298164, 2371771, 2415135, 2281787, 2415127, 2412282, 2371768, 2240388, 2266394, 2318890, 2302374, 2423597, 2385177, 2434372, 2283535, 2427683, 2400931, 2397432, 2450095, 2260704, 2366656, 2348182, 2333525, 2249430, 2254652, 2415143, 2392293, 2283519, 2240398, 2454214, 2254646, 2327641, 2318880, 2323533, 2343929, 2294883, 2281774, 2420415, 2272118, 2431218, 2298166, 2415133, 2408421X, 2249426, 2412284, 2379406, 2281785, 2266392, 2237988, 2310211, 2302376, 2385175, 2434374, 2474491, 2294873, 2283533, 2254649, 2400933, 2450093, 2272108, 2333527, 2249432, 2358872, 2235672, 2254650, 2277085, 2415141, 2366658, 2348184, 2343931, 2454216, 2454208, 2457378, 2327643, 2375441, 2318882, 2385169, 2323531, 2314068, 2266401, 2450083, 2281772, 2420417, 2353030, 2415128, 2294881, 2283525, 2415131, 2244986, 2249424, 2404336, 2438894, 2441567, 2441571, 2441573, 2441575, 2445542, 2457385, 2438889, 2441577, 2445544, 2441568, F2446599, 2441578, 2412280, 2445546, 2434369, 2438891, 2438895, F2446600, 2441572, 2441580, 2441574, 2445543, 2441576, 2445545, 2441569, 2412283, 2445547, F2446598, 2441579, 2412281, 2438892, 2445548, 2438890, 2412285, and 2438896;
 
9) Units: 2459645, 2459647, and 2459648;
 
10) Unit: F2493318;
 
11) Units: F2495663, F2493319, F2495666, and F2495657;
 
12) Units: 2308255, F2485874, 2290140, 2276837 and F2483175;
 
13) Units: 2344820, 2308259, 2308209, 2267963, and 2374689;
 
14) Unit: 2323338;
 
15) Units: F2472543, 2334365, 2267962, F2421472, 2363719, F2493981, F2421474, F2467070, 2286315, F2483177, F2485875, F2421473, F2457386, 2440177, F2460867, and F2448559;
 
16) Units: 2358838, 2418999, 2293473, 2344814, 2472147, 2456784, 2321276, 2253269, 2344815, 2293476, 2262190, 2344822, and 2396187;
 
17) Unit: 2323340
RECALLING FIRM/MANUFACTURER
Cook, Inc., Bloomington, IN, by letter dated April 21, 2010. Firm initiated recall is ongoing.
REASON
The set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheotomy tube component that has been associated with cuff leakage as a result of the pilot balloon inflation assembly.
VOLUME OF PRODUCT IN COMMERCE
28,819 units
DISTRIBUTION
Nationwide, Canada, Mexico, Australia, Chile, Costa Rica, Denmark, Dominican Republic, Guatemala, India, Malaysia, Panama, Peru, Puerto Rico, Republic of Korea, Trinidad and Tobago, and Uruguay
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
1) Artificial ligament fixation device # 7PE ZIPLOOP Extended Toggle, Sterile, REF 904755. Intended for soft tissue to bone fixation. Recall # Z-1952-2010;
 
2) Toggleloc Artificial ligament fixation device ZIPLOOP Technology Implant Kit, Sterile, REF 909848. Intended for soft tissue to bone fixation. Recall # Z-1953-2010
CODE
1) Lot Numbers: 047510, 050400, 050420, 089710, 089800, 182820, 192240, 192250, 192280, 219260, 219270, 219280, 228530, 228550, 228580, 228590, 228610, 228620, 295450, 361020, 361020, 392930, 392990, 483490, 483500, 529380, 527780, 529800, 529810, 582890, 582910, 627510, 648470, 648480, 671130, 671150, 671170, 671180, 671190, 671240, 706150, 706160, 782360, 782370, 821710, 821730, 943000, 943010, 943030, 952040, 952070 and 974140;
 
2) Lot Numbers: 228150, 228160, 783930, 975220, 975230 and 975240
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letters dated March 31, and June 2, 2010. Firm initiated recall is ongoing.
REASON
The firm has received complaints that the saddle is too long. The saddle is supposed to be between 7/8 and 1 1/8 inches long. The saddle in the complaints was up to 1.9 inches long.
VOLUME OF PRODUCT IN COMMERCE
2,466 units
DISTRIBUTION
Nationwide, Canada, Australia, The Netherlands, Belgium, Italy, France, New Zealand, Austria, United Kingdom, Chile, Greece, Poland, Denmark, Turkey, Portugal, South Africa and Spain
___________________________________
PRODUCT
Howmedica Osteonics Corp, Stryker Orthopedics Passport A.R. Knee Instrumentation Distal Guide Stand; Catalog number 7650-5005. Recall # Z-2118-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letters dated April 8, 2010. Firm initiated recall is ongoing.
REASON
There is the potential for the posts on the Distal Resection Guide Stand to disassociate from the main body part.
VOLUME OF PRODUCT IN COMMERCE
676 Nationwide, 1305 Internationally.
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
X-Celerate Instrumentation Punch Thru Tibial Base Plate, Catalog numbers: 3750-0003. 3750-0004, 3750-0005, 3740-0006, 3750-0007, 3750-0009, 3750-0011, 3750-0013; Stryker Howmedica Osteonics Corp Scorpio Total Knee System. Recall # Z-2119-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters dated April 5, 2010. Firm initiated recall is ongoing.
REASON
The locating pins on the Punch Thru Tibial Baseplates could break or disassociate from the main body of the instrument.
VOLUME OF PRODUCT IN COMMERCE
8276 units nationwide; 18264 internationally
DISTRIBUTION
Nationwide, China, Taiwan, India, Australia, Korea, Singapore, Germany, France, Spain, Italy, Switzerland, Poland, Romania, South Africa, United Kingdom, Netherlands, Sweden, Turkey, Japan, Chile, Brazil, Colombia, Mexico, Panama, Argentina, and Uruguay
___________________________________
PRODUCT
Howmedica Osteonics Corp., Stryker Orthopedics Passport A.R. Knee Instrumentation Anterior Skim Guide; Catalog Number 7650-5003. Recall # Z-2120-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters dated April 5, 2010. Firm initiated recall is ongoing.
REASON
One of the two posts on the Anterior Resection Guide could disassociate from the main body of the part which has been determined to be caused by a fracture weld.
VOLUME OF PRODUCT IN COMMERCE
682 Nationwide; 1292 Internationally
DISTRIBUTION
Nationwide, Ireland, Germany, Sweden, The Netherlands, France, Italy, Switzerland, South Africa, United Kingdom, Japan, Argentina, Mexico, Miramar (city), China, Taiwan, India, Australia, Korea, New Zealand, Malaysia, Singapore, and Canada
___________________________________
PRODUCT
1) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code # DR135412. Recall # Z-2122-2010;
 
2) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code # DR135415. Recall # Z-2123-2010;
 
3) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code # DR135417. Recall # Z-2124-2010;
 
4) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code # DR135420. Recall # Z-2125-2010;
 
5) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code # DR135512. Recall # Z-2126-2010;
 
6) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code # DR135515. Recall # Z-2127-2010;
 
7) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code # DR135517. Recall # Z-2128-2010;
 
8) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code # DR135520. Recall # Z-2129-2010;
 
9) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code # DR135612. Recall # Z-2130-2010;
 
10) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code # DR135615. Recall # Z-2131-2010;
 
11) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code # DR135620. Recall # Z-2132-2010;
 
12) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code # DR135712. Recall # Z-2133-2010;
 
13) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code # DR135715. Recall # Z-2134-2010;
 
14) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code # DR135717. Recall # Z-2135-2010
 
15) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code # DR135720. Recall # Z-2136-2010
CODE
1) Lot Numbers: 93DT0019, 93DT0050, 93DT0205, 93FT0310;
2) Lot Numbers: 93DT0101, 93DT0103, 93FT0034, 93FT0293, 93JT0068;
3) Lot Numbers: 93DT0104, 93DT0105, 93GT0108;
4) Lot Number: 93GT0144;
5) Lot Number: 93FT0028;  
6) Lot Numbers: 93FT0257, 93GT0148, 93IT0185, 93IT0213;
7) Lot Numbers: 93FT0052, 93IT0212;
8) Lot Numbers: 93FT0237, 93GT0093;
9) Lot Numbers: 93FT0166, 93IT0184;
10) Lot Numbers: 93IT0145, 93IT0167;
11) Lot Numbers: 93ET0113, 93FT0026, 93IT0168, 93JT0084, 93JT0153, 93KT0158;
12) Lot Number: 93FT0152;
13) Lot Numbers: 93DT0146, 93DT0175, 93IT0211, 93IT0211;
14) Lot Number: 93FT0217;
15) Lot Numbers: 93FT0218, 93HT0155
RECALLING FIRM/MANUFACTURER
Bard Peripheral Vascular Inc., Tempe, AZ, by letter beginning May 7, 2010. Firm initiated recall is ongoing.
REASON
The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft.
VOLUME OF PRODUCT IN COMMERCE
3,279 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Exacta-Mix EVA Container, Sterile R, 250 mL, Order No. REF: 137. Recall # Z-2137-2010;
 
2) Exacta-Mix EVA Container, Sterile R, 500 mL, Order No. REF: 138. Recall # Z-2138-2010;
 
3) Exacta-Mix EVA Container, Sterile R, 1000 mL, Order No. REF: 139. Recall # Z-2139-2010;
 
4) Exacta-Mix EVA Container, Sterile R, 2000 mL, Order No. REF: 140. Recall # Z-2140-2010;
 
5) Exacta-Mix EVA Container, Sterile R, 3000 mL, Order No. REF: 141. Recall # Z-2141-2010;
 
6) Exacta-Mix EVA Container, Sterile R, 4000 mL, Order No. REF: 142. Recall # Z-2142-2010;
 
7) Exacta-Mix EVA Container, Sterile R, 5000 mL, Order No. REF: 143. Recall # Z-2143-2010;
 
8) Halobag EVA Dual-Chamber Bag, Sterile R, 3000 mL Total Volume W/500 mL upper chamber, Order No. REF: 341. Recall # Z-2144-2010;
 
9) Exacta-Mix Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL Reorder No. H938 371 3. Recall # Z-2145-2010;
 
10) Exacta-Mix 2400 Valve Assembly w/Calibration Bag, Sterile R, 250 mL, Order No. REF: 724. Recall # Z-2146-2010;
 
11) Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled, Tubing Kit w/Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL, Order No. REF 706.Recall # Z-2147-2010;
 
12) Exacta - Mix Valve Set, Six Inlet, Tubing Kit w/Calibration Bag, Fluid Path is sterile and non-pyrogenic in unopened, undamaged package, 250 mL, Order No. REF: 706D. Recall # Z-2148-2010
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxa Corp., Englewood, CO, by letter on May 26, 2010.
Manufacturer: AVAILMED S.A. DE C.V., Tijuana, Mexico. Firm initiated recall is ongoing.
REASON
Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
VOLUME OF PRODUCT IN COMMERCE
12,612,066 bags
DISTRIBUTION
Nationwide, Argentina, Australia, Bermuda, Brazil, Canada, China, Colombia, Hong Kong, Malaysia, Mexico, New Zealand, Pakistan, Panama, South Korea, Taiwan, United Kingdom, and Uruguay
___________________________________
PRODUCT
1) Terumo Cardiovascular Procedure Kit Custom Open Perfusion Pack P/N 64937. Recall # Z-2149-2010; 
 
2) Terumo Cardiovascular Procedure Kit Custom 1:1 CONDUCER/MP4 CRYSTALLOID CARDIOPLEGIA P/N 65246. Recall # Z-2150-2010;  
 
3) Terumo Cardiovascular Procedure Kit Custom MP4, 4:1, PRELIEF, W/RECIRC, COND / PUMP & TABLE PACK P/N 65503/70881-02. Recall # Z-2151-2010;
 
4) Terumo Cardiovascular Procedure Kit Custom 8:1 CARDIOPLEGIA SET P/N 70608-01. Recall # Z-2152-2010;
 
5) Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PRESTIGE PACK P/N 71544-01. Recall # Z-2153-2010;
 
6) Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N 71546-01. Recall # Z-2154-2010;
 
7) Terumo Cardiovascular Procedure Kit Custom PERFUSION TUBING PACK P/N 71733. Recall # Z-2155-2010;
 
8) Terumo Cardiovascular Procedure Kit Custom X-COATED HEART/LUNG FRAMEPACK P/N 71766PP. Recall # Z-2156-2010;
 
9) Terumo Cardiovascular Procedure Kit Custom X-COATED PERFUSION PACK P/N 71934. Recall # Z-2157-2010;
 
10) Terumo Cardiovascular Procedure Kit Custom X-COATED PUMP AND TABLE PACK W/8:1 CARDIOPLEGIA P/N 72642. Recall # Z-2158-2010;
 
11) Terumo Cardiovascular Procedure Kit Custom X-COATED MASTER PACK P/N 72790. Recall # Z-2159-2010;
 
12) Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PACK P/N 72846. Recall # Z-2160-2010;
 
13) Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N: 131351-02. Recall # Z-2161-2010;
 
14) Terumo Cardiovascular Procedure Kit Custom X-COATED HEART - LUNG PACK P/N: 70608-01. Recall # Z-2162-2010;
 
15) Terumo Cardiovascular Procedure Kit Custom CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE P/N: 71032. Recall # Z-2163-2010
CODE
1) Lot: ME05;
2) Lots: ME19, MF10;
3) Lots: ME19, MF03;
4) Lots: ME19, ME26;
5) Lot: MD22;
6) Lot: MF03;
7) Lot: ME26;
8) Lots: ME05, ME26, MF03;
9) Lots: ME19, ME19T, MF17;
10) Lots: MD22, ME26, MF03;
11) Lots: ME19, MF10;
12) Lot: MF03;
13) Lot: ME19;
14) Lot: ME19;
15) Lot: ME19
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ashland, MA, by telephone, fax, and email on June 8, 2010 and letter on June 9, 2010. Firm initiated recall is ongoing.
REASON
Vent port maybe occluded and prevent delivery of fluid.
VOLUME OF PRODUCT IN COMMERCE
589 kits
DISTRIBUTION
Nationwide and Canada
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels, catalog number KS855. For in vitro diagnostic use. Recall # Z-2117-2010
CODE
Lot numbers NH20-309-09, NH20-330-09, NH20-337-09, and NH20-001-10
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated March 2010. Firm initiated recall is complete.
REASON
Vessel pick up errors and vessel jams when the vessel is being loaded. The error halts the instrument and disrupts processing. Vessel flange is thin.
VOLUME OF PRODUCT IN COMMERCE
5,544 bags
DISTRIBUTION
Nationwide, Canada, Europe, Japan, Korea, and New Zealand
 
END OF ENFORCEMENT REPORT FOR AUGUST 4, 2010
 
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