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U.S. Department of Health and Human Services

Safety

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Enforcement Report for August 19, 2009

August 19, 2009
09-33

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT 
Dr. Smoothie Bio Bar Whole Food Nutrition Bar Peanut Butter Crunch; Net Wt. 2.0 oz. (56g); UPC Item # for Individual bars: 6 47854 42610 7; UPC Item # for 15 Count packs: 6 47854 26121 0, Recall # F-731-9
CODE
Lot #'s: BB 02FEB08; BB 13APR08; MFG 30MAY07 BB 11OCT08; BB 05MAR09; BB 21MAY09; BB 21NOV09. Note: BB=Best By
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dr. Smoothie Enterprises, Fullerton, CA, by press release on February 27, 2009 and March 12, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
29,681 bars
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Charlie’s All American Whoopie Pie 4 oz. The product is shipped in cases containing 30 pies. UPC 6-11690-21751-9; Product # 21751, Recall # F-732-9;
 
2) Chocolate Bobb pies with peanut butter filling. This product is a bulk product sold as a 4 pack of pies. The product is cases containing 15 packs. UPC 6-11690-41751-3, Recall # F-733-9
CODE
Product does not have lot numbers
RECALLING FIRM/MANUFACTURER
Charles Specialties, Inc., Hermitage, PA, by telephone on February 4-5, 2009 and by press release and telephone on February 6, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
68,340
DISTRIBUTION
PA, WV, NY, OH
___________________________________
PRODUCT 
Peanuts, splits, dry roasted. Firm repacks dry roasted split peanuts into 5 lb. clear plastic bags. Label includes "DRYPEANUT 5 lbs (2.27kg) net wt, Recall # F-734-9
CODE
No codes
RECALLING FIRM/MANUFACTURER
Merlino Foods, Seattle, WA, by telephone on February 2, 2009. Firm initiated recall is complete.
REASON
Product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
3,940 lbs (788 – 5 lb packages)
DISTRIBUTION
WA, OR
___________________________________
PRODUCT 
PB & Whey Protein Bites. High -Protein / High Energy Protein Bites, Organic Peanut Butter. Packaged in Paper Boxes and/or Plastic Jars. UPC 8 90391 00100 3, 1.25 oz individually wrapped UPC 8 90391 00101 0, 1.25 oz individually wrapped in 45 count container. UPC 8 90391 00108 9, 1.25 oz individually wrapped in 15 count boxes, Recall # F-735-9
CODE
Best By Dates: 06NOV08; 07NOV08; 12DEC08; 03MAR09; 12MAY09; 07JUL09; 17SEP09; 10NOV09
RECALLING FIRM/MANUFACTURER
Recalling Firm: EB Performance, LLC, Boca Raton, FL, by telephone and e-mail on February 17, 2009 and by press release on February 23, 2009. Firm initiated recall is ongoing.
REASON
Products were manufactured using peanut pieces recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
20,000 individually wrapped bars
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Nature's Candy Peanut Butter Krinkle, Net Wt 1.7 Oz, packaged a) 24 to a box, b) 9 units in a Family Pack, c) 60 units in a Small Bulk Pack, and d) 100 units in a Large Bulk Pack. 24-pack has UPC code 0-54486-10011-2, F-736-9;

2) Nature's Candy Karob Krinkle Fudgey, Net Wt 1.7 Oz, a) packaged 24 to a box, 9 bars in a b) Family Pack, and c) 100 units in a Large Bulk Pack. 24-pack has UPC code 0-54486-10014-3, Recall # F-737-9;

3) Nature's Candy Peanut Chip Crunch, Net Wt 1.7 oz and Net Wt. 2.1 oz, packaged 24 units in a box. UPC for 1.7 oz size is 0-54486-10208-6. UPC for 2.1 oz size is 0-54486-10238-3, Recall # F-738-9; 

4) Omega-3 Peanut Caramel Uplift Bar, Net Wt. 2.25 oz, packaged 18 bars in a box, UPC Code 0-54486-10101-0, Recall # F-739-9 
CODE
1) a) Lot #: x931; b) Lot #: x898; c) Lot #'s: 6301, 6327, 6414, 6418, 6432, and 6451; d)  Lot #'s: 6315, 6327, 6369, 6398, 6414, and 6432;

2) a) Lot #'s: x891, x904, and x933; b) Lot number x905; c) Lot number 6439;

3) Lot #'s: 6345 and 6428;

4) Lot #'s: 0206, 0207, 0208, 0209, 0210, 0211, 0212, and 090809
RECALLING FIRM/MANUFACTURER
Beneficial Foods, Fredericksburg, TX, by letter on February 26, 2009 and press release on March 1, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,208 units
DISTRIBUTION
Nationwide, British Columbia, Canada
___________________________________
PRODUCT 
Swiss Cheese Sauce Seasoning 50#BG, FA887701, For Manufacturing and Professional Use Only, Recall # F-740-9
CODE
Lot #’s 5055497001, 5055497002, 5057315501, 5057315502, 5057315503, 5057792001, 5057792002, 5057792003, 5057792004, 5057828001, 5057828002, 5057828003, 5057828004, 5057828005, 5057828006, 5058982401, 5058982402, 5058982403, 5058982404, 5058982405, 5058982406, 5058982407, 5059517401, 5059517402, 5059517403, 5059517404, 5059517405, 5059517406, 5059517407, 5059517408, 5059517409, 5060299901, 5060299902, 5060299903, 5060299904, 5060299905, 5060299906, 5062047301, 5062047302, 5062047303, 5062443401, 5062443402, 5062443403, 5062443404, 5062443405, 5062443406, 5064590201, 5064590202, 5064590203, 5065993001, 5065993002, 5065993003, 5065993004, 5065993005, 5065993006, 5065993007, 5065993008, 5065993009, 5065993010, 5065993011, 5065993012, 5066909801, 5066909802, 5066909803, 5066909804, 5066909805, 5066909808, 5066909809, 5066909810, 5067249301, 5067249302, 5067249303, 5067249304, 5067249305, 5067249306, 5067249307, 5067249308, 5068725501, 5068725502, 5068725503, 5069268601, 5069268602, 5069268603, 5069268604, 5069268605, 5069268606, 5069962901, 5069962902, 5069962903, 5070944001, 5070944002, 5070944003, 5070944004, 5070944005, 5070944006, 5070944007, 5070944008, 5070944009, 5070944010, 5070944011, 5070944012, 5070944013, 5070944014, 5070944015, 5071451101, 5071451102, 5071451103, 5071451104, 5071451105, 5071451106, 5072226803, 5072226804, 5072226805, 5072226806, 5072226807, 5072226808, 5072226809, and 5072226810  
RECALLING FIRM/MANUFACTURER
McCormick Flavor Division, Irving, TX, by letter on June 25, 2009. Firm initiated recall is ongoing.
REASON
Product was manufactured using an ingredient recalled by Plainview Milk Products Cooperative because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
328,550 pounds
DISTRIBUTION
KY, CA
___________________________________
PRODUCT 
1) Valeriana Brand Milk Mix 17.6 oz bags. The product is shipped 20 bags per case, Recall # F-741-9;

2) taZZa DI RISA Whimsical White Chocolate 3.5 lb bags. The product is shipped 5 bags per case, Recall # F-742-9
CODE
1) Lot #’s: 9104010 and 9162049;
 2) Lot #: 9148019
RECALLING FIRM/MANUFACTURER
World Flavors, Inc., Warminster, PA, by e-mail on June 25, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using an ingredient recalled by Plainview Milk Products Cooperative because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
335 cases
DISTRIBUTION
PR, TX
___________________________________
PRODUCT 
Hot Chocolate Recovery Drink Mix from Clif Shot, a brand of Clif Bar, in 40 oz. Foil Pouches, Recall # F-743-9
CODE
Best by dates of 19SEP09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Clif Bar, Berkeley, CA, by press release on July 8, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using an ingredient recalled by Plainview Milk Products Cooperative because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,928 packets
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
L A Hot Drinks Cafe Au Lait Artificially Flavored 7 Envelopes Net Wt. 4.07 oz. (115.5g), UPC 6 55958 00365 0. The front of the brownish yellow box is labeled in part, "***L A Hot Drinks**Cafe Au Lait**Artificially Flavored**7 Envelopes Net Wt. 4.07 oz (115.5g)***" The back panel containing nutrition facts chart is labeled in part, "***INGREDIENTS: Nonfat Dry Milk, Soy Protein Isolate, Instant Decaffeinated Coffee, Calcium Caseinate, Corn Syrup Solids, Partially Hydrogenated Canola Oil, Sodium Caseinate, Artificial Flavors, Dispotassium Phosphate, Aspartame, Acesulfame potassium, Mono and Diglycerides, Turmeric and Annatto Extracts (for color). **ALLERGY INFORMATION: Contains milk and soybean ingredients, Recall # F-744-9
CODE
Lot code 0806 with BEST BY 08/13/09; lot code 0806 with BEST BY 08/14/09; lot code 0821 with BEST BY 11/28/09; lot code 0830 with BEST BY 01/30/10 and lot code 0830 with BEST BY 01/31/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Associated Brands, Mississaug, Canada, by press release on July 10, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using an ingredient recalled by Plainview Milk Products Cooperative because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
403 cases/40 retail boxes/7 envelopes
DISTRIBUTION
GA, IL, WA, NC, LA, TX, SD, ND, IA, TN, KY, MO, WI
___________________________________
PRODUCT 
1) Blue Dog Instant Nonfat Dry Milk, Vitamins A & D Added; nonfat dry milk packaged in a paper foil laminate pouch, Net Wt. 20 grams, 200 pouches per case; item 1386-X1999, Recall # F-746-9;

2) French Vanilla Latte/Cappuccino Mix, Latte Mix 69858; a nondairy creamer/dried milk blend packaged in a paper foil laminate packet , Net Wt. 34 grams, 90 packets per case; item D600-V1636, 0 80 72058 60183 6, Recall # F-747-9;

3) Land O Lakes Madagascar Vanilla International Drinking Cocoa, Brimming with Chocolatey Flakes; Net Wt 12.5 oz. (354 g) multi-serving foil bag, 6 bags per case; Land O Lakes brandmark is  used by license; case UPC 10 8 78326 00541 5; bag UPC 8 78326 00071 0, Recall # F-748-9
CODE
1) Lot #'s: B8024K12, B8025K12, B8028K12 and B8029K12;

2) Lot #'s: B7339K92, B7339K48, B7339K49, B7340K49, B7340K50, B7340K51, B7341K51, B7344K23, B7344K24, B7345K25, B7345K26, B7346K26, B7354K68, B7355K68, B7355K69, B7356K69, B7356K70, B7360K70, B7360K25, B7361K25, B7361K26, B7362K26, B7362K11, B7362M10, B7363M10, B7363K11, B7363K12, B7365K12, B7365M10, B8002M10, B8002M46, B8002K12, B8002K46, B8003M46, B8003M44, B8011K50, B8014K50, B8014K53, B8015K53, B8015K58, B8016K58, B8016K59, B8017K59, B8017K96, B8017K49, B8018K49, B8018K50, B8021K50, B8021K06, B8021K07, B8022K07, B8028M07, B8028M08, B8029M08, B8029M31, B8030M31 and B8031K33;

3) Best By 09/04/10 and Best By 11/05/10
RECALLING FIRM/MANUFACTURER
Precision Foods, Inc., Bolingbrook, IL, by press release on July 2, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using milk ingredients recalled by Plainview Milk Products Cooperative because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
20,899 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Whey Protein Blend Cup Cake Batter flavor. The product is sold in 2lb, 5lb, 10 lb, 15lb, 20lb, 25 lb, and 50lb containers, Recall # F-749-9; 

2) Whey Protein Concentrate unflavored. The product is sold in 2lb, 5lb, 10 lb, 15lb, 20lb, 25 lb, and 50lb containers, Recall # F-750-9;

3) Supermass 600 Chocolate flavor. The product is sold in 2lb, 5lb, 10 lb, 15lb, 20lb, 25 lb, and 50lb containers, Recall # F-751-9;

4) Supermass 600 Vanilla flavor. The product is sold in 2lb, 5lb, 10 lb, 15lb, 20lb, 25 lb, and 50lb containers, Recall # F-752-9;

5) Opti-Blend Chocolate flavor. The product is sold in 2lb, 5lb, 10 lb, 15lb, 20lb, 25 lb, and 50lb containers, Recall # F-753-9;

6) Opti-Blend Vanilla flavor. The product is sold in 2lb, 5lb, 10 lb, 15lb, 20lb, 25 lb, and 50lb containers, Recall # F-754-9 
CODE
1) Lot #'s: 9108, 9115, 9122, 9129, 9136, 9143, 9150, 9157, 9164, 9171, 9178, 9185, and 9192;

2) Lot #'s: 9108, 9115, 9122, 9129, 9136, 9143, 9150, 9157, 9164, 9171, 9178, 9185, and 9192;

3) Lot #'s: 9108, 9115, 9122, 9129, 9136, 9143, 9150, 9157, 9164, 9171, 9178, 9185, and 9192;

4) Lot #'s: 9108, 9115, 9122, 9129, 9136, 9143, 9150, 9157, 9164, 9171, 9178, 9185, and 9192;

5) Lot #'s: 9108, 9115, 9122, 9129, 9136, 9143, 9150, 9157, 9164, 9171, 9178, 9185, and 9192;

6) Lot #'s: 9108, 9115, 9122, 9129, 9136, 9143, 9150, 9157, 9164, 9171, 9178, 9185, and 9192
RECALLING FIRM/MANUFACTURER
All The Whey, Inc., Paoli, PA, by email on July 1, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using whey protein concentrate recalled by Milk Specialties Global because it was processed at Plainview Milk Products Cooperative and has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
52,908 lbs
DISTRIBUTION
Internet sales
___________________________________
PRODUCT 
1) Max Gourmet Protein Chocolate Banana Cream Pie, Recall # F-755-9;
2) Max Gourmet Protein Chocolate Fudge Brownie, Recall # F-756-9;
3) Max Gourmet Protein Peanut Butter Fudge, Recall # F-757-9;
4) Max Gourmet Protein Vanilla Caramel, Recall # F-758-9;
5) Max Gourmet Protein Strawberry, Recall # F-759-9;
6) Max Gourmet Gainer Chocolate, Recall # F-760-9;
7) Max Gourmet Gainer Vanilla, Recall # F-761-9;
8) Max Gourmet Gainer Strawberry, Recall # F-762-9;
9) Max Lean Chocolate, Recall # F-763-9;
10) Max Lean Vanilla, Recall # F-764-9;
11) Max Lean Strawberry, Recall # F-765-9;
12) High 5 Pineapple Banana, Recall # F-766-9;
13) High 5 Banana, Recall # F-767-9; 
14) High 5 Chocolate, Recall # F-768-9;
15) High 5 Cappuccino, Recall # F-769-9;
16) High 5 Orange, Recall # F-770-9;
17) High 5 Strawberry, Recall # F-771-9;
18) High 5 Vanilla, Recall # F-772-9;
19) Big Max 50 Chocolate, Recall # F-773-9;
20) Big Max 50 Vanilla, Recall # F-774-9; 
21) Big Max 50 Strawberry, Recall # F-775-9;
22) Triple Whey Chocolate Cream, Recall # F-776-9;
23) Triple Whey Strawberry Cream, Recall # F-777-9;
24) Triple Whey Vanilla Cream, Recall # F-778-9;
25) Max Pro Natural Vanilla, Recall # F-779-9;
26) Max Pro Vanilla, Recall # F-780-9;
27) Max Pro Banana, Recall # F-781-9;
28) Max Pro Strawberry, Recall # F-782-9;
29) Max Pro Orange Blast, Recall # F-783-9 
CODE
1) Lot #’s: 194644004-00909-1, 194644004-01209-2, 194644004-00909-1, and 000194004-02809-1;

2) Lot #’s: 194674002-01009-1, 194674002-01009-2, 194674002-01209-3, 194674002-01209-4, 194674002-01209-5, and 000224002-02809-1;

3) Lot #’s: 194664006-00909-1, 194664006-01209-1, and 000214006-02909-1;

4) Lot #: 000204006-2809-1;

5) Lot #: 000234001-2809-1;

6) Lot #’s: 00001402-2909-1, 00001402-2909-2, 00001402-3609-1, and 00001402-3609-2;

7) Lot #’s: 000024000-3609-1 and 000024000-3509-1;

8) Lot #’s: 000034001-02909-2 and 000034001-03609-2;

9) Lot #’s: 19403002-1409-1 and 19403002-1409-2;

10) Lot #: 194713000-1309-1;

11) Lot #: 194713001-1309-1;

12) Lot #’s: 19461502-01409-1, 19461502-01409-2, 19461502-01409-3, 19461502-05409-1, and 19461502-05409-2;

13) Lot #: 19652501-05509-1;
 
14) Lot #’s: 19459506-01509-1, 19459506-01509-2, 19459506-01509-3, 19459506-01509-4, 19459506-01509-1, 19459506-01609-5, 19459506-01609-6, 00015506-03309-1, 00015506-03309-2, 00015506-03309-3, and 00015506-03309-4;

15) Lot #: 19458505-01609-1;
 
16) Lot #’s: 19358504-1409-1 and 19358504-1409-2;
 
17) Lot #’s: 19456203-1509-1, 19456203-1509-2, 19456203-1509-3, 19456203-1509- 4, 1965750305609-1, 1965750305609-2, and 1965750305609-3;

18) Lot #’s: 196585000-05409-1, 196585000-05409-2, 196585000-05509-3, 196585000-05509-4, 196585000-05509-5, 196585000-05409-1, 19463500-1209-2, 19463500-01309-3, 19463500-1309-4, and 19463500-1309-5;

19) Lot #’s: 019444009-01609-1, 019444009-01609-2, 019444009-01609-3, 019444009-01609-4, 019444009-01609-5, 019444009-01609-6, and 019444009-01609-7;

20) Lot #’s: 019446008-01309-1, 019446008-01309-2, 019446008-01309-3, 019446008-01309-4, and 019446008-01309-5;

21) Lot #’s: 019449010-01509-1, 019449010-01509-2, 019449010-01509-3, and 019449010-01509-4;

22) Lot #’s: 000335001-03009-1, 194875001-02109 and 194875001-2109-4;

23) Lot #: 000345000-03009-1;

24) Lot #: 000335002-0300901;

25) Lot #’s: 00028611-03509-1 and 00028611-03509-2;

26) Lot #’s: 00027606-03509-1, 00027606-03509-2, 00027606-03509-3, 00027606-03509-4, 00027606-03509-5, and 00027606-03509-6;

27) Lot #’s: 00024609-03509-1 and 00024609-03509-1;

28) Lot #: 0002603-04109-1;

29) Lot #:  00029608-03509-1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Max Muscle Sports Nutrition, Anaheim, CA, by press release on July 3, 2009.
Firm initiated recall is ongoing.
REASON
Potential salmonella contamination of whey protein concentrates. Conducted as an extension of the Plainview Milk Products Cooperative recall.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide, Indonesia, New Caledonia, Ecuador, Greece, Slovakia, Austria, Brazil, India, Japan, Sweden, Hong Kong, Netherlands, Taiwan, Malta, and Italy
___________________________________
PRODUCT 
1) Purity Nutty Caramel Ice Cream; vanilla ice cream swirled with caramel sauce and chocolate covered peanuts; Half Gallon square carton, UPC 0 70778 56200 0, Recall # F-784-9; 

2) Peanut Caramel Crunch Ice Cream; vanilla ice cream with caramel swirl with candy bar blend and chocolate covered peanuts; the ice cream was sold under the following labels and sizes: a) Louis Trauth Dairy LLC Deluxe Peanut Caramel Crunch Ice Cream; i) 8 oz. cups - UPC 70777 25204, ii) half gallon square cartons - UPC 0 70777 00565 2, iii) 2.5 gallon bulk can - food service; b) Broughton Premium Peanut Caramel Crunch Ice Cream; i) 1.75 Quarts (56 oz.) scround cartons - UPC 0 70880 02346 8, ii) 3 gallon bulk cans - food service, Recall # F-785-9
CODE
1) Best by date: 12/01/09 or earlier;
2) Best by dates prior to 11/26/09and Best by dates: 01/01/08 or later
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dean Foods CO, Inc., Rockford, IL, by press release on February 3, 2009, letters dated February 1, 2009, February 2, 2009 and February 3, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
8,000 - 8 oz. cups, 91,200 .5 gal. squares, 200 - 2.5 gal. cans; 2,436 - 56 oz. cartons, 32 - 3 gal. cans
DISTRIBUTION
TN, KY, AL, OH, IN, IL, WV, VA
___________________________________
PRODUCT 
Mini Peanut Butter Cookie. Packaged in plastic clamshell containers. Label reads, in part, "Living Healthy never tasted so Good FABE'S all natural bakery Mini Peanut Butter naturally sweetened no sugar added no trans fat Net Weight 7 oz”. First three ingredients are white grape juice, peanut butter and organic unbleached wheat flour. UPC: 7 55729 00182 0, Recall # F-786-9
CODE
Code dates: 0701-07365, 08001-08365
RECALLING FIRM/MANUFACTURER
Fabes Natural Gourmet, Inc., San Fernando, CA, by emails, and visits on March 3, 2009 and by press release on March 20, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut product recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
3,000 units
DISTRIBUTION
CA, CO, IL, WI
___________________________________
PRODUCT 
Tower Gift by Creative Options Unlimited: Product is a gift tower comprised of different sized tin and cardboard boxes stacked on top of each other and which contain a variety of snack packages. Gift baskets may contain recalled honey roasted peanuts packaged in a clear plastic bag and labeled in part, "Honey Roasted Peanuts coated in Honey Batter ". UPC: 0-32491-15584-6, Recall # F-787-9 
CODE
No codes used
RECALLING FIRM/MANUFACTURER
Creative Options Unlimited, Otis Orchards, WA, by telephone on March 20, 2009 and by letters on March 23, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
102 gift towers
DISTRIBUTION
WA, ID

___________________________________
PRODUCT 
1) Hannaford Denali Nutty Moose Tracks Premium Ice Cream, vanilla ice cream with choco covered peanuts, peanut butter cups and famous Moose Tracks fudge, 1.75 Quart, UPC 4126815394 and 16 oz, UPC 4126815447, Recall # F-788-9;
 
2) Tin Roof Sundae Ice Cream, Chocolate Peanuts in Vanilla Ice Cream Swirled with Fudge Sauce. Giant Tin Roof Sundae Ice Cream, 1.75 Quart, UPC 8826704824 and Tops Tin Roof Sundae, 1.75 Quart, UPC 8826704824,  Recall # F-789-9;

3) Shurfine Premium Select Candy Bar Swirl Ice Cream, candy bar pieces and caramel swirl in candy bar flavored ice cream, 1.75 Quart, UPC 1540022181, Recall # F-790-9;

4) House of Flavors Premium Ice Cream Candy Bar Whirl, Caramel Sauce and Snickers Bar Stir-Ins Dessert Toppings in Snickers Flavored Ice Cream, Half Gallon, UPC 7761951333, Recall # F-791-9;

5) Welsh Farms Snickers Ice Cream, nougat flavored ice cream with caramel ripple and snickers pieces, 24 fl. oz., UPC 7761930106, Recall # F-792-9

6) Candy Factory ice cream. 4313 Premium Candy Factory Ice Cream, net 3 gal, UPC 7761904313, Recall # F-793-9

7) Snickers ice cream. 1421 Snicker's, net 3 gal, House of Flavors, UPC 7761901421 and 9533 Snickers, Richman, net 3 gal, UPC 7761909533, Recall # F-794-9
CODE
1) All lots with a stamped code date of 09028 or earlier;

2) a) Lots with code dates of 07261 and 07279; b) Code dates of 07213 and 07279;

3) Lots with code dates of 07135, 07207, 07328, 08137, 08238, 08150, 08278, 08289 and 08194

4) Lots with code dates of 07166, 07340 and 08233;

5) Lots with code dates of 08150, 08230 and 09012;

6) Lot with code dates of 07137 and 08118;

7) a) Lots with code dates of 08039, 08141, 08194, 08215, 08222 and 08329;  b) Lots with code dates of 08182, 08194 and 08329
RECALLING FIRM/MANUFACTURER
House of Flavors, Inc., Ludington, MI, by press release on February 2, 2009 and by press release and letter on February 27, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
50,211 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Country Life Natural Foods Carob Bridge Mix, net wt. 12 oz., item number 270542 and net wt. 5 lbs., item number 270542, Recall # F-795-9;

2) Country Life Natural Foods Carob Peanuts, net wt. 12 oz., item number 271208, Recall # F-796-9 
CODE
All lots bear a 3 to 5 digit lot code and all lots with a middle number of 7 or 8 are under recall.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oak Haven, Inc., Pullman, MI, by press release on February 4, 2009, by telephone between January 29, 2009 and February 9, 2009 and by letter dated February 13, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,320 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Gayle’s Chocolate, sugar free chocolate covered peanuts, net wt. 10 oz; UPC 3447803065, Recall # F-797-9
CODE
Any product purchased on or before February 13, 2009.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gayle’s Chocolates, Ltd, Royal Oak, MI, by press release and e-mail on February 13, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
48 units
DISTRIBUTION
MI
___________________________________
PRODUCT 
1) Awrey Marquise Chocolate Peanut Fantasy Cake, net wt. 2 lb. 12 oz.; Product code 7250. The cake is sold frozen, Recall # F-798-9;

2) Awrey Marquise Cake Variety Assortment #1, 4 cakes per, net wt. 10.75 lb; Product code 7290. The four types of cakes included in the case are: Raspberry Nut Cake, Product 7230; Tropical Chocolate Cake, Product 7240; Chocolate Peanut Fantasy Cake, Product 7250 and Raspberries & Crème Cake, Product 7280. The cakes are sold frozen, Recall # F-799-9;

3) Awrey Marquise Banana Split Ripple Cake, net wt. 2 lb 11 oz.; Product codes 374520 and 374521. The cakes are sold frozen, Recall # F-800-9    
CODE
1) Lot #’s: 020608, 022008, 031108, 031808, 032808, 040408, 041008, 041908, 042308, 042508, 050108, 050708, 060308, 61008, 072408, 072808, 080108, 091708, 101708, 112008, 120308, 121208 and 020309;

2) Lot #’s: 020608, 022008, 031108, 031808, 032808, 040408, 041008, 041908, 042308, 042508, 050108, 050708, 060308, 61008, 072408, 072808, 080108, 091708, 101708, 112008, 120308, 121208 and 020309;

3) Lot #’s: 020608, 022008, 031108, 031808, 032808, 040408, 041008, 041908, 042308, 042508, 050108, 050708, 060308, 061008, 072408, 072808, 080108, 091708, 101708, 112008, 120308, 121208 and 020309
RECALLING FIRM/MANUFACTURER
Awrey Bakeries, LLC, Livonia, MI, by press release and letter on March 27, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
15,191 cases of 4 cakes each
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
Braum’s Peanut Butter Pretzel Premium Ice Cream, 3 ½ Gallon Squares, no UPC; Half Gallon, UPC #400000 00109; and 3 pint sizes, UPC #400000 021096, Recall # F-801-9 
CODE
All lots and date codes
RECALLING FIRM/MANUFACTURER
Braums Ice Cream Stores, Tuttle, OK, by email and press release on February 3, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
37,418 units
DISTRIBUTION
AR, KS, MO, OK, TX

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
Nitrofurantoin Monohydrate/Macrocrystals Capsules USP, 100 mg. (Twice a day Dosage), Urinary Tract Antibacterial, 100 count bottles, Rx only, Recall # D-1884-2009
CODE
Batch Code: 1769205, Exp 4/09; 1769797, Exp 4/09; 177533, Exp 4/09; 1784346, Exp 5/09; 1784352, Exp. 5/09; 1799902, Exp 7/09; 1799904, Exp. 7/09; 1799905, Exp. 7/09; 1809409, Exp. 7/09; 1809411, Exp. 7/09; 1823823, Exp. 9/09; 1823825, Exp. 9/09; 1828044, Exp 9/09; 1828045, Exp 9/09; 1828046, Exp. 9/09; 18242193, Exp. 11/09; 1852520, Exp. 12/09; 1852527, Exp. 12/09; 1873962, Exp. 2/10; 1873963, Exp. 2/10; 18880851, Exp. 2/10; 1881355, Exp. 2/10; 1895945, Exp. 3/10; 1902050, Exp. 4/10; 1904599, Exp. 4/10; 1784353, Exp 5/09; 1852528, Exp. 5/09; 1852528, Exp. 12/09; 1895946, Exp. 5/10; 1895947, Exp 5/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ranbaxy Pharmaceuticals, Inc., Princeton, NJ, by letters on May 1, 2009.
Manufacturer: Ranbaxy Laboratories, Limited, New Delhi, India. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Specification.
VOLUME OF PRODUCT IN COMMERCE
263,139 capsules
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Isosorbide Mononitrate Extended-Release Tablets, 30 mg, 100 Bags of One Tablet Each, Rx only, (ETHEX NDC) NDC 58177-222-11, D-1885-2009;

2) Potassium Chloride Extended-release Capsules, USP, 10 mEq (750 mg), 100 Bags of One Capsule Each, Rx only, NDC 58177-001-11 (ETHEX NDC), Recall # D-1886-2009 
CODE
1) Lot # 084610, Exp 06/12; Lot # 084741, Exp 06/12; Lot # 080846, Exp 07/11; Lot # 081324, Exp 07/11; Lot # 074739, Exp 03/11; Lot # 075164, Exp 03/11; Lot # 072945, Exp 01/11; Lot # 073432, Exp 01/11; Lot # 071711, Exp 10/10; Lot # 071116, Exp 10/10; Lot # 066048, Exp 06/10; Lot # 066443, Exp 06/10; Lot # 068039, Exp 06/10; Lot # 070004, Exp 06/10;

2) Lot # 080851, Exp 08/10; Lot # 074872, Exp 03/10; Lot # 073305, Exp 12/09; Lot # 072004, Exp 11/09; Lot # 071053, Exp 10/09; Lot # 068333, Exp 07/09; Lot # 066983, Exp 04/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH, by letters on February 2, 2009 and February 5, 2009.
Manufacturer: KV Pharmaceutical Co Westport, Saint Louis, MO. Firm initiated recall is ongoing.
REASON
The products were not manufactured in conformance with cGMP’s.
VOLUME OF PRODUCT IN COMMERCE
924 units (100 tablets per unit)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
SENNA-TIME (Sennosides) Micro Coated Clear Tablets, 8.6 mg, 100 Bags of One Tablet Each, NDC 63739-431-10 (McKESSON NDC), Recall # D-1888-2009
CODE
Lot # 080281, Exp 04/09; Lot # 081067, Exp 04/09; Lot # 081642, Exp 04/09; Lot # 081641, Exp 10/09; Lot # 081808, Exp 10/09; Lot # 082449, Exp 10/09; Lot # 082953, Exp 10/09; Lot # 083730, Exp 01/10; Lot # 084142, Exp 01/10; Lot # 084745, Exp 04/10; Lot # 084965, Exp 04/10; Lot # 090282, Exp 04/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH, by letters on May 8, 2009.
Manufacturer: Time-Cap Labs, Farmingdale, NY. Firm initiated recall is ongoing.
REASON
The tablets may contain undeclared lactose and tartaric acid.
VOLUME OF PRODUCT IN COMMERCE
1,959 units (100 tablets per unit)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Fenoglide (fenofibrate) tablets, 120 mg, 7 tablet Professional Sample bottle, Rx only; NDC 59630-495-07, Recall # D-1889-2009
CODE
Lot # 0802584, Exp 10/09 
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sciele Pharma, Inc., Atlanta, GA, by letters on July 10, 2009, July 13, 2009 and August 10, 2009.
Manufacturer: Catalent Pharma Solutions LLC, Winchester, KY. Firm initiated recall is ongoing.
REASON
The product may lack efficacy due to the Out of Specification dissolution result at the 9-month stability pull point.
VOLUME OF PRODUCT IN COMMERCE
58,176 units (7 count bottles)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Fentanyl Transdermal System, 100 mcg/hr, Rx only, Packaged as 5 foil pouches per carton, 3214-54, Carton NDC 0591-3214-72, Recall # D-1891-2009
CODE
Lot # 145287A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watson Pharmaceuticals, Inc., Corona, CA, by letter on August 10, 2009. Manufacturer: Watson Pharmaceuticals, Salt Lake City, UT. Firm initiated recall is ongoing.
REASON
Possibility for leakage of Fentanyl gel from transdermal patches.
VOLUME OF PRODUCT IN COMMERCE
87,500 cartons
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
Mucinex DM (guaifenesin and dextromethorphan HBr) extended-release bi-layer tablets, 600 mg guaifenesin and 30 mg dextromethorphan HBr, 40 tablets per bottle; Outer Carton 20-count NDC 63824-056-20, Bottle 40-count NDC 63824-056-40, Recall # D-1887-2009
CODE
Lot # WO00387272
RECALLING FIRM/MANUFACTURER
Reckitt Benckiser, Fort Worth, TX, by e-mail, letter on June 5, 2009. Firm initiated recall is ongoing.
REASON
Product was mis-packed; 40-count bottle was packaged in an individual carton indicating a 20-count volume.
VOLUME OF PRODUCT IN COMMERCE
1,283 cases (30,792 units)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Colchicine Injection, USP FOR IV USE1 mg/0.5 mg/mL Rx ONLY, NDC 55390-605-02 2 mL vial, Recall # D-1890-2009
CODE
Lot # 957876, Exp. Date 08/09
RECALLING FIRM/MANUFACTURER
Bedford Laboratories, Bedford, OH, by letters on August 3, 2009. Firm initiated recall is ongoing.
REASON
Failed PH Specification @ 24 months.
VOLUME OF PRODUCT IN COMMERCE
31,870 vials = 3,187 boxes/10/1mg/2mL vials
DISTRIBUTION
Nationwide and Israel

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1277-09
CODE
Unit: 012FJ48930
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone on May 8, 2007.
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood product, which was labeled as Kell negative due to incorrect testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced, Recall # B-1338-09;
2) Platelets, Recall # B-1339-09
CODE
1) and 2) Unit: W227708041788
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by fax and letter on March 4, 2009. 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
TN
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced, Recall # B-1342-09;
2) Fresh Frozen Plasma, Recall # B-1343-09
CODE
1) and 2) Units: W045008033997, W045008112160
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, by letter dated May 1, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MO, KS
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-1345-09
CODE
Unit: 1481226
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by electronic notification on April 20, 2009 or by letter dated April 28, 2009. 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
PA 
___________________________________
PRODUCT 
Platelets, Recall # B-1347-09
CODE
Unit: W035209044607Z
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on March 18, 2009 and by letter dated April 20, 2009. 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
TX
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced, Recall # B-1348-09;
2) Cryoprecipitated AHF, Recall # B-1349-09
CODE
1) and 2) Unit: 27KW06811
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone or electronic notification on March 20, 2009 and by letter dated March 23, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA, KY
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1351-09
CODE
Units: 2098357, 4001909
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated March 19, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1352-09
CODE
Unit: W035209012431V
RECALLING FIRM/MANUFACTURER
Carter BloodCare/WE & Lela Stewart Blood Center, Inc., Tyler, TX, by letter dated April 8, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had taken aspirin within 48 hours of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1353-09
CODE
Unit: W118809551319
RECALLING FIRM/MANUFACTURER
The Blood Alliance, Inc., Jacksonville, FL, by telephone on February 27, 2009. Firm initiated recall is complete.
REASON
Blood product, which was labeled leukoreduced, but exceeded the acceptable limit for white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced, Recall # B-1375-09;
2) Platelets, Recall # B-1376-09
CODE
1) Unit: 4053319;
 2) Unit: 4056171
RECALLING FIRM/MANUFACTURER
Wellmont Health System dba Marsh Regional Blood Center, Kingsport, TN, by facsimile on October 4, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN, MD
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced, Recall # B-1377-09;
2) Fresh Frozen Plasma, Recall # B-1378-09;
3) Cryoprecipitated AHF, Recall # B-1379-09;
4) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1380-09
CODE
1) Units:  3657507, 3657509, 3657511, 9753644, 9753645, 9753647, 9754211, 9754215, 9754216, 9754217, 9754220, 9754223, 9754532, 9754535, 9754748, 9754749, 9754909, 9754913, 9754917, 9754978, 9754979, 9754988, 9754990, 9755003, 9755005, 9755021, 9755024, 9755029, 9755032, 9755034, 9755408, 9755410;
 
2) Units: 3657507, 3657509, 3657511, 9754532, 9754535, 9755023, 9755029, 9755034, 9755413;

3) 9753021, 9753025, 9753868, 9753872, 9753874, 9753996, 9754000, 9754001;

4) Units: 9754980, 9755023, 9755138
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile beginning May 29, 2008. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
92 units
DISTRIBUTION
LA, NY, TX, AR
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1397-09
CODE
Unit: 72K079221
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on March 19, 2009. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1398-09
CODE
Unit: 72J998565
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on February 11, 2009. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1399-09    
CODE
Unit: 72J630586
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on February 28, 2009. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1401-09
CODE
Unit: W117008155015
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on March 30, 2009 and follow-up letter dated March 31, 2009. 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
CA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1402-09
CODE
Unit: 72K124792
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Lecanto, FL, by fax on March 1, 2009.
Manufacturer: LifeSouth Community Blood Centers, Inc., Brooksville, FL. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1407-09
CODE
Unit: 72K24246X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Wiregrass Region, Dothan, AL, by facsimile on April 7, 2009. 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
AL

___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1408-09
CODE
Unit: 72K172138
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Wiregrass Region, Dothan, AL, by facsimile on April 11, 2009.
Manufacturer: LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL. 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
AL
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1409-09
CODE
Unit: W045009005500 Part 1 and Part 2   
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, by telephone on May 12, 2009. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MO
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1447-09   
CODE
Unit: 19GG89420
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by letter and telephone on February 23, 2009, by facsimile on February 24, 2009. 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 
1) Red Blood Cells Leukocytes Reduced, Recall # B-1451-09;
2) Plasma Frozen, Recall # B-1452-09
CODE
1) and 2) Unit: W053308507669
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by letter or electronic notification on February 6, 2009. 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
2 units
DISTRIBUTION
Switzerland, AL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes (Apheresis) Reduced, Recall # B-1491-09
CODE
Unit: 29H02470 (split product)
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic Region, Norfolk, VA, by telephone on October 10, 2008 and follow-up letter dated October 20, 2008. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised their sterility, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1494-09   
CODE
Unit: W0363085057965
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax on April 16, 2009. 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
WI
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1495-09 
CODE
Unit: 06GF46728
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone and email on March 26, 2009. 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
CA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced, Recall # B-1497-09;
2) Liquid Plasma, Recall # B-1498-09
CODE
1) and 2) Units: W044609229768
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by fax on April 22, 24 and 28, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was deferred for high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX, NJ
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1499-09   
CODE
Unit: W035808060212
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Mather, CA, by telephone and fax on March 24, 2009. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1500-09 
CODE
Units: W044609280554, W044609234216 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by fax on March 20, 23 and 25, 2009. Firm initiated recall is complete.
REASON
Blood products, with an absolute red cell volume below the specified minimum requirement, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1501-09 
CODE
Unit: W037909121001
RECALLING FIRM/MANUFACTURER
Blood Center of Iowa, Des Moines, IA, by telephone on March 23, 2009. Firm initiated recall is complete.
REASON
Blood product, with an absolute red cell volume below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IA
___________________________________
PRODUCT 
1) Platelets Leukocytes Reduced, Recall # B-1504-09;
2) Red Blood Cells leukocytes Reduced, Recall # B-1505-09 
CODE
1) and 2) Units: 22FS72491
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by letter on April 9, 2009 and May 5, 2009. 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
MD, PA
___________________________________
PRODUCT 
Source Plasma, Recall # B-1506-09
CODE
Unit: 08DILC0068
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., DeKalb, IL, by email on May 7, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Source Plasma, Recall # B-1507-09
CODE
Unit: 06JMOE4049
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Joplin, MO, by fax on May 14, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1508-09
CODE
Unit: 50LS17406
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by telephone, letter and email on April 8, 2009. 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
MI
___________________________________
PRODUCT 
Source Plasma, Recall # B-1510-09
CODE
Unit: 08JMOF4046
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, LP, Joplin, MO, by fax on April 23, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose scheduled physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1511-09   
CODE
Unit: 2716113
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by fax on March 12, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the drug Imuran, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Source Plasma, Recall # B-1130-09   
CODE
Unit: AQ030686
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by facsimile on September 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1174-09   
CODE
Unit: AQ030626
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on September 20, 2007. 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-1175-09   
CODE
Unit: AQ030621
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on September 28, 2007. 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-1221-09   
CODE
Unit: AQ030599
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on October 10, 2007. 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-1222-09   
CODE
Unit: AQ030482
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on October 2, 2007. 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-1223-09   
CODE
Unit: AQ030463
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on September 20, 2007. 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-1240-09   
CODE
Unit: AQ030447
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on September 28, 2007. 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-1241-09   
CODE
Unit: AQ030480
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on September 20, 2007. 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 
Recovered Plasma, Recall # B-1344-09
CODE
Unit: 1481226
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by electronic notification on April 20, 2009 or by letter dated April 28, 2009. 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
Switzerland
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1350-09
CODE
Unit: 27KW06811
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone or electronic notification on March 20, 2009 and by letter dated March 23, 2009. 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 
Source Plasma, Recall # B-1359-09   
CODE
Unit: AQ030762
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on October 2, 2007. 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-1360-09   
CODE
Unit: AQ030652
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on October 2, 2007. 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-1361-09   
CODE
Unit: AQ030451
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on September 28, 2007. 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-1363-09   
CODE
Unit: AQ030442
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on September 28, 2007. 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-1364-09   
CODE
Unit: AQ030649
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on September 28, 2007. 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-1365-09   
CODE
Unit: AQ030745
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on October 1, 2007. 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-1366-09   
CODE
Unit: AQ030653
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on September 28, 2007. 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-1367-09   
CODE
Unit: AQ030607
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on October 2, 2007. 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-1368-09   
CODE
Unit: AQ030658
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on October 2, 2007. 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-1369-09   
CODE
Unit: AQ030638
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on October 2, 2007. 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-1370-09   
CODE
Unit: AQ030687
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on October 2, 2007. 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 
Recovered Plasma, Recall # B-1448-09   
CODE
Unit: 19GG89420
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by letter and telephone on February 23, 2009, by facsimile on February 24, 2009. Firm initiated recall is complete. 
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1496-09 
CODE
Unit: 06GF46728
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone and email on March 26, 2009. 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
CA
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1503-09 
CODE
Unit: 22FS72491
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by letter on April 9, 2009 and May 5, 2009. 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
CA
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1509-09
CODE
Unit: 50LS17406
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by telephone, letter and email on April 8, 2009. 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
CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT 
1) Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8512, Size 6, 4 boxes of 50, Sterile. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs, Recall # Z-1583-2009;

2) Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8513, Size 6 1/2, 4 boxes of 50, Sterile. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs, Recall # Z-1584-2009;

3) Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8514, Size 7, 4 boxes of 50, Sterile. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs, Recall # Z-1585-2009;

4) Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8515, Size 7 1/2, 4 boxes of 50, Sterile. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs, Recall # Z-1586-2009;

5) Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8516, Size 8, 4 boxes of 50, Sterile. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs, Recall # Z-1587-2009;

6) Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8517, Size 8 1/2, 4 boxes of 50, Sterile. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs, Recall # Z-1588-2009;

7) Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8518, Size 9, 4 boxes of 50, Sterile. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs, Recall # Z-1589-2009
CODE
1) Lot #: 0810015305;

2) Lot #'s: 0810007705, 0810006605, 0812017905, and 0810015405;

3) Lot #'s: 0810003305, 0180007305, 0810007805, 0810015505 and 0810006705;

4) Lot #'s: 0810003405, 0810014405, 0810007905 and 0810015805;

5) Lot #'s: 0811015605, 0810008005, 0810014505, 0810015605 and 0811017805;

6) Lot #'s: 0810003605 and 0810015705;

7) Lot #: 0811017405
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ansell Healthcare Products LLC, Dothan AL, by letters on May 1, 2009 and May 4, 2009.  
Manufacturer: Ansell Lanka (Pvt), Ltd., Biyagama (Columbo), Sri Lanka. Firm initiated recall is ongoing.
REASON
Premature degradation which could result in tearing during use.
VOLUME OF PRODUCT IN COMMERCE
560,000 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles with Silicone Tip, for human use with insulin pen injector device to administer insulin subcutaneously, Recall # Z-1596-2009
CODE
Part # Lot # Exp Date PNS-100 SBSM-1107-1 11/2012 SBSM-0608-1 06/2013 and SBSM-1008-1 10/2013; PNX-100 SBSM-1107-1 11/2012 SBSM-0408-1 04/2013 SBSM-0508-1 05/2013 SBSM-0608-1 06/2013 SBSM-0908-1 09/2013 SBSM-1008-1 10/2013 and SBSM-1108-1 11/2013; PNM-100 SBSM-1107-1 11/2012 SBSM-0408-1 04/2013 SBSM-0508-1 05/2013 SBSM-0608-1 06/2013 SBSM-0908-1 09/2013 SBSM-1008-1 10/2013 and SBSM-1108-1 11/2013; 24-1010 (PNS-100) SBAL-1107-1 11/2012; 24-1215 (PNX-100) SBAL-1107-1 11/2012; and 24-1210 (PNM-100) SBAL-1107-1 11/2012
RECALLING FIRM/MANUFACTURER
Stat Medical Devices, Inc., Miami, FL, by letter dated June 18, 2009. Firm initiated recall is ongoing.
REASON
Stat Pen Needles with silicone coating have not been cleared by FDA for use with silicone coating which could significantly affect the safety and effectiveness of the device.
VOLUME OF PRODUCT IN COMMERCE
6,424,100 units
DISTRIBUTION
Nationwide, Canada, and Saudi Arabia
___________________________________
PRODUCT 
1) Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile; Cat. no./REF 6647, a) inner pouch UPN M00566470 and b) outer carton UPN M00566471. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means, Recall # Z-1625-2009;

2) Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile; Cat. no./REF 6649, a) inner pouch UPN M00566490 and b) outer carton UPN M00566491. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means, Recall # Z-1626-2009;

3) Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free, sterile; Cat. no./REF 6653, a) inner pouch UPN M00566530 and b) outer carton UPN M00566531. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means, Recall # Z-1627-2009;

4) Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, for use with pre-filled lidocaine syringe, latex free, sterile; Cat. no./REF 6673, a) inner pouch UPN M00566730 and b) outer carton UPN M00566731. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means, Recall # Z-1628-2009;

5) Boston Scientific EndoVive 20Fr (8 mm) Safety PEG Kit, Push Method, for use with pre-filled lidocaine syringe, latex free, sterile; Cat. no./REF 6675, a) inner pouch UPN M00566750 and b) outer carton UPN M00566751. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means, Recall # Z-1629-2009;

6) Boston Scientific EndoVive 20F (6.7 mm) Standard PEG Kit, Push Method, latex free, sterile; Cat. no./REF 6821, inner pouch UPN M00568210 and outer carton UPN M00568211. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means, Recall # Z-1630-2009;

7) Boston Scientific EndoVive 24F (8 mm) Standard PEG Kit, Push Method, latex free, sterile; inner pouch UPN M00568250 and outer carton UPN M00568251. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means, Recall # Z-1631-2009;

8) Boston Scientific EndoVive 20F (6.7 mm) Standard PEG Kit, latex free, sterile; Cat. no./REF 6840, inner pouch UPN M00568400 and outer carton UPN M00568401. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means, Recall # Z-1632-2009    
CODE
1) a) Lot #'s: 11898070, 11900304, 11098441, 11915503, 11916278, 11922657, 11930346, 11952977, 12018370, 12143998 and 12149325; and  b) Lot Numbers: 11906398, 11931539, 11942414, 11946168, 11957022, 11960383, 11963776, 11974413, 12000788, 12069495, 12300003, 12307021, 12318714 and 12392032;

2) a) Lot #'s: 18893672, 11942231 and 12163810; and b) Lot Numbers: 11934737 and 11996717;

3) a) Lot #'s: 11941297 and 11996705; and b) Lot Numbers: 11941297 and 11996705;

4) a) Lot #'s: 11894862, 11897679, 11899718, 11904793, 11905227, 11912161, 11913781, 11913782, 11929586, 11930733, 11935764, 11951838, 11953294, 11964849, 11967137, 11969145, 11970300, 12150268 and 12150824; and b) Lot Numbers: 11903831, 11906396, 11910014, 11910478, 11921219, 11921661, 11928182, 11928186, 11931538, 11939122, 11946172, 11946477, 11949498, 11957027, 11960387, 11978330, 11982282, 11985367, 12005063, 12009465, 12011789, 12019531, 12019534, 12021780, 12025626, 12296086 and 12303610;

5) a) Lot #'s: 11905226, 11916062, 11963680, 12018369 and 12166919; and b)  Lot Numbers: 11906394, 11928185, 11949741, 11957023, 12025627, 12069497, 12300004 and 12465518;

6) Lot #'s: 11891623, 11906069, 11906483, 11910447, 11927475, 11927476, 11944992, 11948406, 11957306, 11969142, 11986977, 12000544, 12001423, 12025303, 12029062, 12046704, 12050348, 12061338, 12061541, 12083903, 12085669, 12110668, 12113349, 12114748, 12115371, 12130647, 12132911, 12149324, 12162040, 12162501, 12163811, 12169382, 12170033 and 12170540;

7) Lot #'s: 11942230, 11988701, 12043256, 12116837 and 12159829;

8) Lot #'s: 11730787 and 12143999
RECALLING FIRM/MANUFACTURER
Boston Scientific, Corp., Spencer, IN, by letter dated May 5, 2009. Firm initiated recall is ongoing.
REASON
The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
VOLUME OF PRODUCT IN COMMERCE
11,592 units
DISTRIBUTION
Nationwide, India, Japan and Slovenia
___________________________________
PRODUCT 
1) Passive Clip Slings; washable sling; these slings are intended for use with ARJO and BHM Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for use with clip slings. The slings are used to assist with the lifting and transportation of a patient in the horizontal or other required position from one place to another and used only by appropriately trained caregivers. Models MAA2XXX, MAA4XXX and MAA7XXX, Recall # Z-1636-2009;

2) Flite Clip Slings; patient specific disposable sling; these slings are intended for use with Arjo and BHM Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for use with clip slings. The slings are used to assist with the lifting and transportation of a patient in the horizontal or other required position from one place to another and used only by appropriately trained caregivers. Model MFA1000M, Recall # Z-1637-2009
CODE
All slings manufactured prior to March 1, 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: ArjoHuntleigh, Addison, IL, by letter dated January 30, 2009.   
Manufacturer: Medibo N.V., Hamont, Achel, Belgium. Firm initiated recall is ongoing.
REASON
If the sling clips are not applied or are applied incorrectly, there is the potential for the patient to fall, resulting in injury to both the patient and/or the caregiver.
VOLUME OF PRODUCT IN COMMERCE
103,108 slings
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine. Recall # Z-1670-2009   
CODE
Lot #: 1208NT
RECALLING FIRM/MANUFACTURER
Recalling Firm: DePuy Spine Inc., Raynham, MA, by visit and by letter beginning February 11, 2009.
Manufacturer: Norwood Tool Co, Dayton, OH. Firm initiated recall is ongoing.
REASON
Tip of Driver may break during use.
VOLUME OF PRODUCT IN COMMERCE
117 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) 12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers a) AK-12123-H, b) CS-12123-E, c) MA-12123, and d) MC-12123. The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins, Recall # Z-1671-2009

2) 12 French 3 Lumen 20 cm Large-Bore Central Venous Catheters. Product numbers a) AK-15123-H, b) AK-15123-J, c) CS-15123-E, and d) MC-15123. The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins, Recall # Z-1672-2009
CODE
1) a) Lot #'s: RF8045004, RF8072289, RF8084254, RF8107640, RF8108841, RF8110482, RF8122717, RF9027113, RF9030981; b) Lot #'s: RF8032041, RF8043417, RF8058142, RF8060023, RF8072220, RF8084333, RF8097145, RF8109080, RF8110116, RF9015982, ZF7126427, ZF8027168, ZF8027448, ZF8037862, ZF8048194, ZF8048672, ZF8059197, ZF8069577, ZF8090983, ZF8091196, ZF8101854, ZF8102010, ZF8112852, ZF8124161, ZF9014366, ZF9025408, ZF9035840, ZF9046856; c) Lot #'s: ZF8027407, ZF8059146, ZF8090984, ZF9014354, ZF9046854; and d) Lot #'s: RF8057141 and RF8083743;

2) a) Lot #'s: RF8020142, RF8029122, RF8031799, RF8045050, RF8084251, RF8123397, RF9027126, and RF9039409; b) Lot #'s: RF8031856, RF8056908, and RF8071778; c) Lot #'s: RF8044326, RF8071238, RF8097152, RF9014658, RFZF8027313, ZF8027652, ZF8037872, ZF8048327, ZF8058745, ZF8069575, ZF8070317, ZF8079993, ZF8080559, ZF8091380, ZF8113337, ZF8123891, ZF9014736, ZF9014737, ZF9014797, ZF9025529, ZF9035668; and d) Lot #'s: RF8044327, RF8069574, RF8084830, RF9016649, and RF9039995
RECALLING FIRM/MANUFACTURER
Arrow International, Inc., Reading, PA, by letter dated May 11, 2009. Firm initiated recall is ongoing.
REASON
Wire guide can have difficulty passing through catheter juncture hub or being removed from the catheter.
VOLUME OF PRODUCT IN COMMERCE
46,610 units
DISTRIBUTION
Nationwide and Belgium, Canada, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Lithuania, Japan, Republic of Korea, Netherlands, New Zealand, Poland, Singapore, Slovakia, South Africa, Spain, Taiwan, Ukraine, and United Kingdom
___________________________________
PRODUCT 
Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R (Red), Four Wheel Aluminum Walker/Rollator, Recall # Z-1674-2009
CODE
Lot/Serial #'s: KLD-E07090001 through KLD-E08020570
RECALLING FIRM/MANUFACTURER
Recalling Firm: Essential Medical Supply, Inc., Orlando, FL, by letters on April 30, 2009 and May 8, 2009.
Manufacturer: Jia Shan Kanglida Physical Therapy Equip. Co., LTD, Jiashan, Zhejiang Provi, China. Firm initiated recall is ongoing.
REASON
The caster may separate from the frame completely causing injury to the user.
VOLUME OF PRODUCT IN COMMERCE
3,610 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. Part 8717741, Recall # Z-1676-2009;

2) Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System; Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. a) Part 10275007, b) part 10275008, c) part 10275009, d) part 10275010, Recall # Z-1677-2009   
CODE
1) Serial #'s 1326, 1315, 1324, 1330, 1310, 1325, 1336, 1307, 1317, 1331, 1299, 1300, 1301, 1302, 1303, 1304, 1305, 1306, 1308, 1309, 1311, 1312, 1313, 1314, 1316, 1318, 1319, 1320, 1322, 1323, 1327, 1328, 1329, 1332, 1334, 1335, and 1337;

2) a) Serial #'s 1043, 1044, 1048, 1049, 1050, 1051, 1052, 1053, 1054, 1055, 1056, 1057, 1058; b) serial numbers 1044, 1054, 1055, 1056, 1057, 1058, 1059, 1060, 1061, 1062, 1063, 1064, 1065; c) serial numbers 1037, 1038, 1039, 1040, 1041, 1042, 1044, 1045; d) serial numbers 1009, 1010, 1011, and 1012
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters dated April 22, 2009. Firm initiated recall is ongoing.
REASON
The pinion gear could crack and cause the gantry to spin freely thereby damaging the Symbia S or T System and potentially injuring a patient during a scan.
VOLUME OF PRODUCT IN COMMERCE
75 units
DISTRIBUTION
Nationwide and Australia, Austria, Brazil, Bulgaria, Canada, China, Finland, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Russia, Spain, Taiwan, and Turkey
___________________________________
PRODUCT 
Trident Hemispherical Acetabular Shell; 72mm, Arc Deposited, Hydroxylapatite Coated, Multi holed; Sterile; Stryker, France. Single use devices intended for cementless fixation within the prepared acetabulum. Intended for use with the mating Trident Polyethylen Cup Inserts; Product Number: 508-11-72J, Recall # Z-1685-2009 
CODE
Lot #: 20282301
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated May 29, 2007. Firm initiated recall is complete.
REASON
Stryker Orthopedics became aware that Trident Hemispherical Shells, Catalog Number 508-11-74J, are actually marked and labeled as Catalog Number 598-11-72J, Lot Code 20282301.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Prolieve Thermo dilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System, for BPH (Benign Prostatic Hyperplasia) Thermotherapy, Material Numbers: a) M0068808022 and b) M0068808170, Recall # Z-1692-2009
CODE
a) Lot/Batch #'s: 604951, 604952, 604953, 604954, 604955, 604956, 604957, 604958, 604959, 604960, 605015, 605016, 605017, 605276, 605277, 605278, 605279, 605280, 605281, 605282, 605283, 605284, 605285, 605286, 605287, 605288, 605289, 605290, 605291, 605292, 605293, 605294, 605295, 605296, 605297, 605298, 605299, 605783, 605784, 605785, 605786, 605787, 605788, 605789, 605790, 605791, 606044, 606045, 606046, 606079, 606080, 606081, 606082, 606083, 606084, 606152, 606182, 606183, 606203, 606299, 606300, 606301, 606302, 606303, 606304, 606420, 606421, 606422, 606423, 606424, 606597, 606598, 606599, 606600, 606601, 606602, 606603, 606604, 606605, 606606, 606607, 606781, 606782, 606829, 606830, 606831, 606832, 606833, 606834, 606879, 606880, 607014, 607015, 607016, 607017, 607018, 607019, 607020, 607021, 607022, 607023, 607024, 607025, 607189, 607190, 607191, 607192, 607193, 607194, 607315, 607316, 607317, 607318, 607321, 607322, 607323, 607324, 607325, 607520, 607521, 607522, 607523, 607524, 607525, 607526, 607527, 607528, 607646, 607735, 607736, 607737, 607738, 607739, 607740, 608160, 608161, 608162, 608163, 608164, 608165, 608166, 608167, 608168, 608169, 608575, 608591, 608592, 608593, 608594, 608595, 608596, 608597, 608602, 608680, 608681, 619219, 619221, 619222, 619311, 619312, 619313, 623435, 623436, 627518, 627519, 628502, 628503, 628504, 633348, 633349, 633350, 637211, 637212, 637216, 637217, 637220, 639295, 639296, 642203, 642204, 642549, 642576, 644535, 644536, 644537, 647635, 647636, 650229, 650230, 650232, 650233, 650234, 651870, 651871, 651872, 653449, and M19406; b) Lot/Batch #'s: 608608, 608609, 608610, 608611, 608612, 651734, 651874, and 651877 
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Marlborough MA, by letter on July 20, 2009. 
Manufacturer: Accellent Juarez, Juarez, Mexico. Firm initiated recall is ongoing.
REASON
Balloon leaks: Boston Scientific has received complaints from the field involving product leaks associated with the anchor balloons and compression balloons. Correspondence between BSC and FDA has led to BSC's decision to remove the Prolieve Catheter Kits from the field.
VOLUME OF PRODUCT IN COMMERCE
26,935 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Zimmer ITST Intertrochanteric/subtrochanteric fixation tapered reamer, nonsterile; REF 2258-50-00, Recall # Z-1701-2009;

2) Zimmer ITST Intertrochanteric/subtrochanteric fixation taper reamer - Asia, nonsterile; REF 2258-50-01. (Note: This product is not distributed in the United States), Recall # Z-1702-2009
CODE
1) Lot #'s: 60633223 and 60740476;
2) Lot #'s: 60639048 and 60657449
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, by letter dated June 5, 2009. Firm initiated recall is ongoing.
REASON
Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa.
VOLUME OF PRODUCT IN COMMERCE
120 units
DISTRIBUTION
Nationwide, China, Germany, Japan, Korea, and Thailand
___________________________________
PRODUCT 
Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Number LSP55, Recall # Z-1703-2009
CODE
All units, no lot numbers
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters dated June 9, 2009. Firm initiated recall is complete.
REASON
The Surgical Protocol has been modified to create separate and distinct surgical protocols, one for the Trident PSL Shell (LSP68) and one for the Trident Hemispherical Shell (LSP69) in order to clarify and highlight the differences in reaming technique.
VOLUME OF PRODUCT IN COMMERCE
2,376 units Nationwide; Internationally - unknown
DISTRIBUTION
Nationwide, Thailand, Australia, New Zealand, Singapore, Canada, Sweden, Switzerland, South Africa, and Belgium
___________________________________
PRODUCT 
IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery, Recall # Z-1704-2009
CODE
Lot #: 08K22270
RECALLING FIRM/MANUFACTURER
Smith & Nephew, Inc., Memphis, TN, by e-mail on January 22, 2009 and by letter dated January 23, 2009. Firm initiated recall is ongoing.
REASON
Incorrect depth gauge mark etched onto guide wire pin. Guide pin is too long.
VOLUME OF PRODUCT IN COMMERCE
99 units
DISTRIBUTION
Nationwide, Switzerland, and Australia

FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT 
Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. Solid Medium recommended for use in qualitative procedures for the isolation and cultivation of mycobacteria, Recall # Z-1733-2009
CODE
Lot #: 763654, Exp. 2009.07.07
RECALLING FIRM/MANUFACTURER
Remel, Inc., Lenexa, KS, by letters dated May 6, 2008. Firm initiated recall is complete.
REASON
The plate labeling is incorrect, but the outer box labeling is correct.
VOLUME OF PRODUCT IN COMMERCE
118 packages
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS III

___________________________________
PRODUCT 
Horse and Colt Wormer packaged in 16-oz. containers under 5 private labels, containing 1.25% pyrantel tartrate (equivalent to 5.671 grams per pound), NADA 092-150. The products were marketed under the following brand names: (1) Kaeco Equine Wormer Pellet for Horses and Colts; (2) Manna Pro Foal & Horse Pelleted Wormer; (3) Durvet Horse & Colt Wormer, NDC 30796-490-31; (4) Farnam Pellet Care P Equine Wormer Pellet; (5) Sportsman's Friend Colt and Horse Wormer, Recall # V-234-2009
CODE
All lots
RECALLING FIRM/MANUFACTURER
Virbac AH, Inc., Fort Worth, TX, by letters on March 9, 2009 and April 29, 2009.
Manufacturer: Virbac Inc., Bridgeton, MO. Firm initiated recall is ongoing.
REASON
Stability failures (subpotent)
VOLUME OF PRODUCT IN COMMERCE
237,708/1-lb. cans
DISTRIBUTION
MO, AZ

END OF ENFORCEMENT REPORT FOR AUGUST 19, 2009

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