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U.S. Department of Health and Human Services

Safety

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Enforcement Report for November 18, 2009

November 18, 2009
09-46

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

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PRODUCT 
1) Honey Roasted Peanuts: Bulk Honey Roasted Peanuts (sold by the pound from self-service bulk bins), UPC 222422 Pre-packed Honey Roasted Peanuts, UPC 72305520422 - "Pre-packed" denotes pre-packaged peanuts (clear clamshell containers from bulk packing facility). Pre-packed 8 oz. Honey Roasted Peanuts, UPC 72305521422 - "Pre-packed" denotes pre-packaged peanuts (clear clamshell containers from bulk packing facility). Recall # F-0001-2010;

2) Blanched Raw Peanuts: Blanched Raw Peanuts (sold by the pound from self-service bulk bins), UPC 222424 - The product is also used in self-serve nut grinders. Pre-packed Blanched Raw Peanuts, UPC 72305520424 - "Pre-packed" denotes pre-packaged peanuts (clear clamshell containers from bulk packing facility). Pre-packed 8 oz. Blanched Raw Peanuts, UPC 72305521424 - "Pre-packed" denotes pre-packaged peanuts (clear clamshell containers from bulk packing facility). Recall # F-0002-2010;

3) Dry Roasted Salted Peanuts: Dry-roasted Salted Peanuts (sold by the pound from self-service bulk bins), UPC 222425 Pre-packed Dry Roasted Salted Peanuts, UPC 72305520425 - "Pre-packed" denotes pre-packaged peanuts (clear clamshell containers from bulk packing facility). Recall # F-0003-2010;

4) Dry-Roasted Unsalted Peanuts: Dry-roasted Unsalted Peanuts (sold by the pound from self-service bulk bins), UPC 222426 Pre-packed Dry Roasted Unsalted Peanuts, UPC 72305520426 - "Pre-packed" denotes pre-packaged peanuts (clear clamshell containers from bulk packing facility). Pre-packed 8 oz. Dry Roasted Unsalted Peanuts, UPC 72305521426 - "Pre-packed" denotes pre-packaged peanuts (clear clamshell containers from bulk packing facility). Recall # F-0004-2010;

5) Oil Roasted Salted Skinless Peanuts: Oil Roasted Salted Skinless Peanuts (sold by the pound from self-service bulk bins), UPC 222430 Pre-packed Oil Roasted Salted Skinless Peanuts, UPC 72305520430 - "Pre-packed denotes pre-packaged peanuts (clear clamshell containers from bulk packing facility). Pre-packed 8 oz. Oil Roasted Salted Skinless Peanuts, UPC 72305521430 - "Pre-packed" denotes pre-packaged peanuts (clear clamshell containers from bulk packing facility). Recall # F-0005-2010;

6) Salted Redskin peanuts: Salted Redskin peanuts (sold by the pound from self-service bulk bins), UPC 222432. Pre-packed 8 oz. Salted Redskin Peanuts, UPC 72305521432 - "Pre-packed" denotes pre-packaged peanuts (clear clamshell containers from bulk packing facility). Recall # F-0006-2010;

7) Raw Spanish peanuts: Raw Spanish Peanuts (sold by the pound from self-service bulk bins), UPC 222436. Pre-packed Raw Spanish Peanuts, UPC 72305520436 - "Pre-packed" denotes pre-packaged peanuts (clear clamshell containers from bulk packing facility). Pre-packed 8 oz. Raw Spanish Peanuts, UPC 72305521436 - "Pre-packed" denotes pre-packaged peanuts (clear clamshell containers from bulk packing facility). Recall # F-0007-2010;

8) Honey Roasted Peanut Butter Stock (sold by the pound from self-service bulk bins), UPC 8782 - the product is also used in self-serve nut grinders. Recall # F-0008-2010;

9) Unsalted Peanut butter Stock (sold by the pound from self-service bulk bins), UPC 9138 - the product is also used in self-serve nut grinders. Recall # F-0009-2010;

10) Organic Peanut Butter Stock (sold by the pound from self-service bulk bins), UPC 9141 - the product is also used in self-serve nut grinders. Recall # F-0010-2010;

11) Pre-packed Oil Roasted Salted Redskin Spanish Peanuts, UPC 72305520432 - "Pre-packed" denotes pre-packaged peanuts (clear clamshell containers from bulk packing facility). Recall # F-0011-2010
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Whole Foods Market Harry's Seafood, Roswell, GA, by e-mail and press release on February 4, 2009.
Manufacturer: Whole Foods Market, Marietta, GA. Firm initiated recall is complete.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
AL, FL, GA, IL, IN, KY, MD, MI, MN, MO, NE, NJ, NC, OH, PA, TN, VA, WI, DC and Canada
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PRODUCT 
1) Raw Spanish Peanuts (no salt), repacked in 10 lb brown paper bags. Firm's white sticker label includes: Packed by: Product name, net weight packed and date packed. Recall # F-0012-2010;

2) Raw Blanched Peanuts (no salt), repacked in 10, 12, 15 and 16 lb brown paper bags. Firm's white sticker label includes: Packed by: Product name, net weight packed and date packed. Recall # F-0013-2010;

3) Raw Salted Blanched Peanuts repacked in 5 and 10 lb brown paper bags. Firm's white sticker label includes: Packed by: Product name, net weight packed and date packed. Recall # F-0014-2010;

4) Raw Spanish Peanuts (salted), repacked in 5, 10, 11, and 16 lb brown paper bags. Firm's white sticker label includes: Packed by: product name, net weight packed and date packed. Recall # F-0015-2010;

5) Peanut Butter Stock (also known as splits), repacked in 1 and 20 lb brown paper bags. Firm's white sticker label includes: Product name, net weight packed and date packed. Recall # F-0016-2010
CODE
1) Product labeled with the following dates packed: 9-9-07, 12-2-07, 2-2-08, 7-7-08, 9-21-08;

2) Product labeled with the following dates packed: 2-2-07, 2-5-07, 3-16-07, 4-17-07, 5-26-07, 7-2-07, 7-20-07, 7-21-07, 8-10-07, 10-28-07, 11-9-07, 11-24-07, 1-14-08, 2-1-08, 8-29-08, 12-20-08;

3) Product labeled with the following dates packed: 3-26-07, 10-14-07, 11-12-07, 4-7-08, 6-15-08, 7-18-08;

4) Product labeled with the following dates packed: 2-5-07, 7-20-07, 7-21-07, 9-3-07, 11-12-07, 12-7-07, 12-10-07, 12-17-07, 1-7-08, 2-15-08, 3-10-08, 5-5-08, 7-10-08, 7-25-08, 10-5-08, 10-9-08, 11-14-08, 11-30-08, 12-12-08;

5) Product labeled with the following dates packed: 6-24-07, 3-1-08  
RECALLING FIRM/MANUFACTURER
Columbia Brand Foods aka CB Corp., Kennewick, WA, by telephone on January 30, 2009, by press release and letter on or about March 2, 2009. Firm initiated recall is complete.
REASON
The products were 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
540 lbs
DISTRIBUTION
WA and OR
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PRODUCT 
TRToppers, Inc., Chopped Old Fashioned Peanut Butter Cookies, P427-250, Net weight 25 lbs, UPC 651844101325, Packaged in plastic lined corrugated box. Recall # F-0017-2010
CODE
Lot codes: 04681, 12381, and 17181
RECALLING FIRM/MANUFACTURER
T R Toppers, Inc., Pueblo, CO, by e-mail on January 29, 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
327/25 lb boxes
DISTRIBUTION
CA
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PRODUCT 
1) OhYeah! Chocolate & Caramel, 85 g., Good Grab 45g and Sample Size 25g, UPC Codes 7 88434 11350 2, 7 88434 11353 3, 7 88434 20028 8. Recall # F-0019-2010;

2) OhYeah! Peanut Butter & Caramel, 85g and Good Brab 45g, UPC Codes 7 88434 11356 4, 7 88434 11359 5, 7 88434 20031 8. Recall # F-0020-2010;

3) OhYeah! Peanut Butter & Strawberry, 85g, UPC Code 7 88434 11362. Recall # F-0021-2010;

4) OhYeah! Creamy Vanilla & Caramel, 85 g. and Sample Size 25 g, UPC Code 7 88434 11407 3. Recall # F-0022-2010;

5) OhYeah! Vanilla Toffee Fudge, 85 g, Good Grab 45g and Sample Size 25g, UPC Code 7 88434 11416 5, 7 88434 11424 0, 7 88434 20054 7. Recall # F-0023-2010;

6) OhYeah! Natural Peanut Butter, 46g, UPC Code 7 88434 11369 4. Recall # F-0024-2010;

7) OhYeah! Natural Peanut Butter Chocolate Chip, 46g, UPC Code 7 88434 11384 7. Recall # F-0025-2010
CODE
1) thru 5) Best By date from March 11, 2008 through March 27, 2010;
6) and 7) Best By date of 07 13 09 08 134A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Iss Research, Charlotte, NC, by e-mail on February 2, 2009.
Manufacturer: Standard Candy Co., Eastman, GA. Firm initiated recall is complete.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
157,031 cases
DISTRIBUTION
AZ, CA, CO, CT, FL, ID, IL, IA, MA, MI, MN, MS, NJ, NY, NC, OH, PAQ, VA, WA and Canada
___________________________________
PRODUCT 
1) Hood Nutty Cone, 6 pack, paper wrapper, 30/case frozen UPC: 44100-23160 Hood Nutty Cone, 24 pack, Paper Carton, 30/case, Frozen UPC 44110-23436. Recall # F-0026-2010;  

2) Hood Premium Candy Bar Whirl-3 gallon, 24 pack, paper carton, 24/case Frozen UPC 44100-24439. Recall # F-0027-2010;

3) Brighams Dice Kream 3 gallon, 24 pack packages, paper carton, 24/case frozen, UPC 24011-60915. Recall # F-0028-2010
CODE
1) Hood Nutty Cones-6 pack; Code on Box: 016-7 026-7 040-7 046-7 047-7 058-7 061-7 067-7 081-7 092-7 141-7 164-7 178-7 184-7 191-7 197-7 199-7 204-7 205-7 212-7 222-7 235-7 241-7 253-7 260-7 263-7 270-7 290-7 312-7 333-7 334-7 354-7 360-7 035-8 066-8
078-8 087-8 100-8 107-8 113-8 143-8 151-8 155-8 164-8 169-8 193-8 198-8 199-8 205-8 206-8 207-8 220-8 226-8 233-8 239-8 24 pack Code on Box: 103-7 215-7 337-7 072-8 189-8 211-8 266-8 294-8;

2) Code on Lid of Can: 0367 1517 1657 3187 1128;

3) Code on Lid of Can 7/15/2009 9/9/2009 2/4/2010
RECALLING FIRM/MANUFACTURER
HP Hood LLC, Lynnfield, MA, by press release and telephone on January 30, 2009. Firm initiated recall is complete.
REASON
The products were 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) 60,697 pkgs and 15,121 pkgs; 2) 3,716 pkgs; 3) 348
DISTRIBUTION
MA, NY, NH, VT, CT, RI, FL
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PRODUCT 
1) Dark Peanut Splits. The product is R&D (1 to 5 lb) samples for ice cream and dairy manufacturers to use to develop new products. Recall # F-0029-2010;

2) Dark Spanish Peanut. The product is R&D (1 to 5 lb) samples for ice cream and dairy manufacturers to use to develop new products. Recall # F-0030-2010;

3) Milk and Caramel Peanut. The product is R&D (1 to 5 lb) samples for ice cream and dairy manufacturers to use to develop new products. Recall # F-0031-2010;

4) NSA Dark Peanut Splits. The product is R&D (1 to 5 lb) samples for ice cream and dairy manufacturers to use to develop new products. Recall # F-0032-2010
CODE
1) Sample numbers: 2314, 2674, 2766, 2842, 2843, 2860, 2871, 2872, 2936, 3078, 3079, 3199, 3307, 3308, 3627/203590, 3943, and 203590;
2) Sample numbers: 2316, 2673, and 3355;
3) Sample numbers: 3010/203940 and 3245;
4) Sample numbers: 3085, 3086, and 3165
RECALLING FIRM/MANUFACTURER
Gertrude Hawks Chocolates Inc, Dunmore, PA, by telephone and letters on February 23, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America (TX) because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
52 lb
DISTRIBUTION
IA, MA, MI, and PA
___________________________________
PRODUCT 
Vanilla Ice Cream with Peanuts and Fudge Sauce. Packaged in plastic wrap inside carton. Label reads, in part, "Humboldt SINCE 1929 CREAMERY...Nutty Supreme Cone Vanilla Ice Cream with Peanuts and Fudge Sauce Artificially Flavored 6 Cones 3 fl oz (89mL) Each 18 fl oz (534 mL). First three ingredients for the ice cream are skim milk, sugar and cream. Topping ingredients: Peanuts Roasted in Peanut Oil. Special storage requirement: Frozen. UPC: 0 52319 30402 7. Recall # F-0033-2010
CODE
Lot # 28308 MFD 100908 EXP 100909 PLT06-2988 and Lot# 28408 MFD 101008 EXP 101009 PLT06-2988. SKU # 52319-30402
RECALLING FIRM/MANUFACTURER
Recalling Firm: Humboldt Creamery Association, Fortuna, CA, by telephone, email, and visit beginning January 30, 2009.
Manufacturer: Humboldt Creamery Association, Los Angeles, CA. Firm initiated recall is complete.
REASON
The product was manufactured using peanut product recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,176 units
DISTRIBUTION
CA, TX
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PRODUCT 
Lion Brand California Fancy Golden raisins in 30 lb. cartons, UPC: 0 76161 03003 3.
30 LBS. NET WT OIL TREATED. Recall # F-0034-2010
CODE
PKD 10 OCT 08SR Time (ex. 09:24)
RECALLING FIRM/MANUFACTURER
Lion Raisins, Inc., Selma, CA, by telephone on July 10, 2009. Firm initiated recall is ongoing.
REASON
The product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
910 cases, 30 lbs per case
DISTRIBUTION
IL
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PRODUCT 
1) Bear Naked all natural trail mix, apapalachian trail mix; cranberries, almonds, cashews, walnut + more, net wt. 26 oz., UPC 5641600174; net wt. 5 oz., UPC 5641600141; net wt. 2.1 oz., UPC 5641600187. Recall # F-0035-2010;

2) Bear Naked all natural trail mix, 12 pack includes 8 appalachian trail mix; 4 hundred mile medley, 12 - 2.1 oz packs, net wt. 1 lb 9.2 oz., UPC 5641600189. Recall # F-0036-2010
CODE
All lots with date codes of Jan 01 2009 through Feb 01 2010. Code example is Apr 19 2990 BN A2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bear Naked, Inc., Norwalk, CT, by press release and letter dated January 31, 2009.
Manufacturer: Pack Ryt, Inc., Thermal, CA. 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
905,004 packages
DISTRIBUTION
Nationwide
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PRODUCT 
1) Dianne's Menu Inspirations Chocolate Peanut Butter Bombe 5lb cake. The product is shipped 2 cakes per case. UPC 10077401811440. Recall # F-0037-2010; 

2) Culinary Secrets Chocolate Peanut Butter Landslide Mousse Dessert 5 lb cake. The product is shipped 2 cakes per case. UPC 822486132484. Recall # F-0038-2010;

3) Dianne's Menu Inspirations Chocolate Peanut Butter Skoopz 5 lb cake. The product is shipped 4 cakes per case. UPC 10077401811099. Recall # F-0039-2010;

4) Dianne's Menu Inspirations Peanut Butter Chocolate Pie 5 lb cake. The product is shipped 4 cakes per case. UPC 10077401705022. Recall # F-0040-2010;

5) Culinary Secrets Dessert Sample Wheel contains 1 slice of 13 different desserts. Chocolate Peanut Butter Landslide Mousse Dessert is a dessert in this sample wheel. Code number 7740181156 UPC 100774018116. Recall # F-0041-2010;
6) Dianne's Variety Pack Bars (4 pack) code number 7740165610 UPC 10077401565102 which includes Menu Inspirations Rocky Road Bars code number 7740165905 and Menu Inspirations Peanut Butter Silk Bars code number 7740165906. The variety pack is also sold as Dianne's Variety Pack Bars (4 presliced bars) code number 7740165615 UPC 10077401656157 which also containers the same to flavor of bars (Rocky Road and Peanut Butter Silk). Recall # F-0042-2010;

7) Dianne's Menu Inspirations Rocky Road Bars 2.5 lbs container. The product is shipped 4 containers per case. Code number 7740181160 UPC 10077401811600. Recall # F-0043-2010;

8) Devonshire Peanut Butter Chocolate Pie 5 lb. The product is shipped 2 pies per case. Code number 600415, UPC 50758108089346. Recall # F-0044-2010;

9) Variety B Dessert Bar Assortment (4 count). Code number 7740188013 UPC 5078108089247 which includes the Devonshire Peanut Butter Chocolate Pie. Code number 600415 and Devonshire Rocky Road Bars. Recall # F-0045-2010  
CODE
1) 008XXX (008 represents 2008). All 008 coded products shipped prior to 1/16/09. Code number 7740181144;

2) 008XXX (008 represents 2008). All 008 coded products shipped prior to 1/16/09. Code number 7740181120;

3)  008XX (008 represents 2008). All 008 coded products shipped prior to 1/16/09. Code number 7740181109;

4) 008XXX (008 represents 2008). All 008 coded products shipped prior to 1/16/09. Code number 7740170502;

5) 008XXX (008 represents 2008). All 008 coded products shipped prior to 1/16/09. Code number 7740181156;

6) 008XX (008 represents 2008). All 008 coded products shipped prior to 1/16/09. Code numbers 740165610 and 7740165615;

7) 008XX (008 represents 2008). All 008 coded products shipped prior to 1/16/09. Code number 77401811460;

8) 008XX (008 represents 2008). All 008 coded products shipped prior to 1/16/09. Code number 600415;

9) 008XX (008 represents 2008). All 008 coded products shipped prior to 1/16/09. Code number 7740188013
RECALLING FIRM/MANUFACTURER
Recalling Firm: H. J. Heinz Co., L.P., Pittsburgh, PA, by letters on January 15, 16 and 30, 2009 and by press release on January 21, 2009.
Manufacturer: Menu Inspirations, Le Center, MN. Firm initiated recall is complete.
REASON
The products were manufactured using peanut butter recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
12,400 cakes
DISTRIBUTION
Nationwide
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PRODUCT 
1) Annie B's Miniature Variety Classic, product no. MVC5. This is a wholesale product. The product is shipped in 50 count boxes, 4 boxes per case. Recall # F-0046-2010;

2) Annie B's Variety Two Miniatures, product no. VTM5. This is a wholesale product. The product is shipped in 50 count boxes, 4 boxes per case. Recall # F-0047-2010;

3) Annie B's Peanut Butter Swirl Bar, product no. PBSB11. This is a wholesale product. The product is shipped in 24 count boxes, 8 boxes per case. Recall # F-0048-2010;  

4) Chocolate Peanut Butter Cake Annie B's Chocolate Peanut Butter Cake, product no. CPB4. This is a wholesale product. The product is shipped one cake per box, 2 boxes per case. QVC Chocolate Peanut Butter Cake, QVC product no M106327, Annie B's product no. C02008. This product is sold exclusively through QVC. The product is shipped one cake per box, 2 boxes per case. Recall # F-0049-2010;

5) Annie B's Individual Peanut Butter Mousse, product no. IPB3. This is a wholesale product. The product is shipped in 12 count boxes, 4 boxes per case. Recall # F-0050-2010;

6) Annie B's Crunchy Peanut Brownie, product no. PBCB11. This is a wholesale product. The product is shipped in 24 count boxes, 8 boxes per case. Recall # F-0051-2010;

7) Annie B's Chocolate Peanut Butter Miniatures, product no. CPBM5. This is a wholesale product. The product is shipped in 100 count boxes, 2 boxes per case. Recall # F-0052-2010;

8) QVC Classic Miniature Collection, QVC product no M106333, Annie B's product no. M00236. This product is sold exclusively through QVC. The product is shipped in 36 count boxes, 4 boxes per case. Recall # F-0053-2010
CODE
1) thru 7) Production dates 080801 through 081231
8) Purchased after 8/11/08
RECALLING FIRM/MANUFACTURER
Annie B’s Confections, Newtown, PA, by telephone and QVC notice on January 29, 2009, and by press release on February 4, 2009. Firm initiated recall is complete.
REASON
The products were 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
15,418 boxes
DISTRIBUTION
NJ and PA

___________________________________
PRODUCT 
Hudsonville Candy Bar Whirl Flavored Ice Cream, thick caramel and candy bar pieces mixed into vanilla ice cream, half gallon, UPC 7043810250. Recall # F-0054-2010
CODE
Lots 143-08, 178-08, 196-08, 288-08 and 315-08
RECALLING FIRM/MANUFACTURER
Hudsonville Creamery & Ice Cream, LLC, Holland, MI, by press release, telephone and e-mail on February 2, 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
38,836
DISTRIBUTION
IN, MI, OH
___________________________________
PRODUCT 
Snak Club Best Value Raw Trail Mix Net Wt. 9.00 oz (255g), UPC 0 87076 31453. Recall # F-0055-2010
CODE
Expiration Code Date of Oct 15 09
RECALLING FIRM/MANUFACTURER
Snak Club, Inc., El Segundo, CA, by letter on March 6, 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
650 sub cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Fannie May brand Chocolate Bridge Mix Candies, packed in 8 oz., 1 lb, 10 oz. and 16 oz. sizes, Item #7103. This product is sold in plastic bags and or metal tins as part of an assortment. The product is distributed in cases with each case containing 12 packages. Recall # F-0056-2010;

2) No Sugar Added Milk Chocolate Covered Peanuts, packed in 8 oz., 1 lb, 10 oz. and 16 oz. sizes, Item #7104. This product is sold in plastic bags and or metal tins as part of an assortment. The product is distributed in cases with each case containing 12 packages. Recall # F-0057-2010  
CODE
1) Invoice Numbers and Dates of Receipt (DOR): 15124, DOR: 12/31/2008; Invoice #14985, DOR: 11/20/2008; Invoice #14856, DOR: 10/27/2008; Invoice # 14666, DOR: 9/30/2008; Invoice #14551, DOR: 9/11/2008; Invoice #14357, DOR: 5/28/2008; Invoice #14087, DOR: 3/24/2008; Invoice #14041, DOR: 3/5/2008; Invoice #13796, DOR: 1/08/2008; Invoice #13506, DOR: 11/07/2007; Invoice #13448, DOR: 10/23/2007; Invoice #13057, DOR: 4/05/2007; and Invoice #12742, DOR: 12/01/2006;

2) Invoice Numbers and Dates of Receipt (DOR): Invoice #15080, DOR: 12/17/2008; Invoice #14668, DOR: 9/30/2008; Invoice #14357, DOR: 05/28/2008; Invoice #14087, DOR: 3/24/2008; Invoice #14041, DOR: 03/05/2008; Invoice #13864, DOR: 1/23/2008; and Invoice #13763, DOR: 12/29/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fannie May Confections, Inc., Canton, OH, by press release on February 5, 2009 and by letter dated February 6, 2009.
Manufacturer: Madelaine Choc. Novelty Co., Ltd., Rockaway Beach, NY. 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
34,210 lbs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Uncle Eddies Vegan Peanut Butter Chocolate-Chip Cookies: 12 oz. Bag, UPC 40559 03302; 3.75 oz individually wrapped, UPC 40559 03305. Recall # F-0058-2010
CODE
221408 thru and including 21509
RECALLING FIRM/MANUFACTURER
International Desserts and Delicacies, Glendale, CA, by press release on January 28, 2009 and by letter, email, and fax beginning February 9, 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
72,000 x 12oz bags (12 bags/case); Note: single unit distribution volume unavailable
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Nature's Path Optimum Energy Bars Peanut Butter flavor - 2 oz (56 g) individual foil wrap bar with UPC code of 0 58449 77715 1. Bars are packed into retail cardboard boxes (12 - 2 oz bars/box) with UPC code of 0 58449 77719 9. Retail box and bar label reads in part, 98230. Recall # F-0059-2010;

2) Nature's Path EnviroKidz Crispy Rice Peanut Choco Drizzle; marketed in US and Canada. 1) US market: Labeled, EnviroKidz ORGANIC Crispy Rice Peanut Choco Drizzle , 1 oz (28 g) individual foil wrap bar with UPC code of 0 58449 43022 3. Bars are packed as follows: A) For retail sale into cardboard box (6 - 1 oz bars/box) with UPC code of 0 58449 43023 0. There are 6 boxes/case. B) Samples: Bars are packed 200 bars per case. 2) Canadian market: Labeled, EnviroKidz ORGANIC*BIOLOGIQUE Crispy Rice Peanut Choco Drizzle, 28 g individual foil wrap bar with UPC code of 0 58449 43020 9. Bars are packed as for retail sale into cardboard box (6 - 28 g bars/box) with UPC code of 0 58449 43021 6. There are 6 boxes/case. Recall # F-0060-2010;

3) Nature's Path Organic Granola Bar Peanut Butter Chunky 1.4 oz (40 g) individual foil wrap bar; marketed in US and Canada. 1) US market: Bar UPC code is 0 58449 89112 3. Bars packaged as follows: A) For retail sale into cardboard box (5 - 1.4 oz bars/box) with UPC code of 0 58449 89110 9. There are 6 retail boxes/case. B) Sample case containing 200 bars. 2) Canadian market: Bar UPC code is 0 58449 8911 6. Bars packaged as follows: A) For retail sale into cardboard box (5 - 1.4 oz (200 g) bars/box) with UPC code of 0 58449 89119 3. There are 6 retail boxes/case. B) Sample case containing 200 bars. Recall # F-0061-2010;

4) Nature's Path Organic Granola Bars Peanut Choco Chocolatey Drizzle, 1.2 oz (35 g) individual foil wrap bar; marketed in US and Canada. 1) US market: Bar UPC code is 0 58449 89136 9. Bars packed as follows: A) For retail sale into cardboard box (5 - 1.2 oz bars/box) with UPC code of 0 58449 89137 6. There are 6 boxes/case. B) Sample case containing 200 bars. 2) Canadian market: Bar UPC code is 0 58449 89134 5. Bars packed as follows: A) For retail sale into cardboard box (5 - 1.2 oz (175 g) bars/box) with UPC code of 0 58449 89135 2. There are 6 boxes/case. B) Sample case containing 200 bars. Recall # F-0062-2010;

5) Nature's Path Organic Peanut Butter Granola Cereal, 11.5 oz (325 g). Cereal packed plastic bag inside cardboard box, with 12 boxes/case. Sold in US and Canada. 1) US market: Box UPC code is 0 58449 89009 6. 1) Canadian market: Box UPC code is 0 58449 89008 9. Recall # F-0063-2010;

6) Nature's Path Organic Granola Bars Variety Pack- Each retail box contains 2 boxes/5 bars of Flax Plus Pumpkin bars and 2 boxes/5 bars Peanut Butter Chunky bars. Bars are 1.4 oz (40 g) individual foil wrap. Product is sold in US and Canada. 1) US market: retail box UPC code is 0 58449 89105 5; 2) Canadian market: Retail box UPC code is 0 58449 89123 9. Recall # F-0064-2010
CODE
1) BEST BEFORE DATE OF 01OCT09A, BEST BEFORE 03FEB09B, BEST BEFORE 29APR09B;

2) 1) US market: 5 APR-09 through 22 JUL 09; 2) Canadian market: 5 APR-09 through 21 JUL 09;

3) 1) US market: BEST BEFORE 26 FEB 08 THROUGH 29 JUL 09; 2) Canadian market: BEST BEFORE 28 FEB 08 THROUGH 28 JUL 09;

4) 1) US market: BEST BEFORE 7 APR 09 THROUGHT 30 JUL 09; 2) Canadian market: BEST BEFORE 28 MAY 08 THROUGHT 30 JUL 09;

5) BEST BEFORE 17 JAN 08 THROUGH 2 SEP 09;

6) 1) US market: BEST BEFORE 5 FEB 08 THROUGH 23 JUN 09; 2) Canadian market: BEST BEFORE 20 MAY 08 THROUGH 21 JAN 09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Natures Path Foods Inc., Richmond, Canada, by press release on January 20, 2009, and press release, e-mail, and letter on January 31, 2009 and February 2, 2009 and by e-mail on February 27, 2009 and by press release on March 3, and March 4, 2009.  
Manufacturer: Nature's Path Foods, Inc., Blaine, WA. Firm initiated recall is complete.
REASON
The products were manufactured using peanut butter and/or peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
5,518,714
DISTRIBUTION
Nationwide, Canada, Vietnam, Jordan, Bahrain, China, Costa Rica, and Hong Kong

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
1) Brompheniramine Phenylephrine Tannate Suspension, each 5mL (one teaspoonful) contains Phenylephrine Tannate, 20 mg and Brompheniramine Tannate, 12 mg., 16 fl. oz. (473 mL), Rx only, NDC 62559-6331-6. Recall # D-034-2010;

2) Brompheniramine Tannate Suspension, 12 mg per 5mL, 4 fl. oz. (473 mL), Rx only,  NDC 62559-6291-4. Recall # D-035-2010  
CODE
1) FBP010, Exp 07/10 UPC: N 3 62559 63316 1;

2) Lot Nos.: FBS001, exp. 03/10; FBS002, exp.09/10, HBS001, exp. 01/11; HBS002, exp. 06/11 UPC: N 3 62559 62914 0
RECALLING FIRM/MANUFACTURER
ANIP Acquisition Co., Gulfport, MS, by letter on September 17, 2009. Firm initiated recall is ongoing.
REASON
Unapproved New Drug.
VOLUME OF PRODUCT IN COMMERCE
17,892 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) CitruShield, Barrier Lotion, 8 fl oz bottle, "Helps Clean, Protect, Heal, and Disinfect", UPC 689076501330. Recall # D-037-2010;

2) Total SkinCare Work, Skin Protection & Safety, 8 fl oz, "Helps heal and repair skin damage, Helps stop bleeding" Benzalkonium Chloride, UPC 12583060277. Recall # D-038-2010;

3) Iron Fist, Barrier Hand Treatment, 2.5 fl oz (75 mL), Kills Germs, Clinically Proven to Kill 99.9% of Germs on Contact, Keeps Killing For Hours, Benzalkonium (0.05%), UPC 894705002045. Recall # D-039-2010;

4) Skin Shield Restaurant, 8 fl oz, Benzalkonium chloride, Invisible Glove: Also protects, cleans, repairs, and disinfects the skin, Made exclusively by Clarcon, UPC 689076501330. Recall # D-040-2010;

5) Skin Shield Industrial, 8 fl oz, Benzalkonium chloride, Also protects, cleans, repairs, and disinfects the skin, Made exclusively by Clarcon, UPC 689076501330. Recall # D-041-2010;

6) Skin Shield Beauty Salon, 8 fl oz, Benzalkonium chloride, Also protects, cleans, repairs, and disinfects the skin, Made exclusively by Clarcon, UPC 689076501330. Recall # D-042-2010  
CODE
No lot numbers or codes
RECALLING FIRM/MANUFACTURER
Clarcon Biological Chemistry Laboratory Inc., Roy, UT, by telephone and e-mail on June 5, 2009 and by letter on June 8, 2009. Firm initiated recall is ongoing.
REASON
Antimicrobial skin sanitizers and hand protectant products may contain high levels of bacteria.
VOLUME OF PRODUCT IN COMMERCE
34,700 bottles (Domestic), 8000 bottles (Mexico)
DISTRIBUTION
MD, UT, Mexico

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
Oxazepam Capsules 15 mg, 500 count bottles. Rx only, NDC 0172-4805-70. Recall # D-033-2010
CODE
Lot number: BEG72A exp 11/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on October 16, 2009.
Manufacturer: Ivax Pharmaceuticals Ireland, Waterford, Ireland. Firm initiated recall is ongoing.
REASON
Presence of foreign tablet; some bottles may contain 10 mg capsules.
VOLUME OF PRODUCT IN COMMERCE
1302 bottles
DISTRIBUTION
AZ, CA, FL, GA, KS, LA, MA, NC, NM, NV, OH, PA, SC, TN, and TX
___________________________________
PRODUCT 
SOTRET (isotretinoin) Capsules, USP, 40 mg, 30 count per carton (3 x 10 capsule Prescription Packs; NDC 10631-586-31. Recall # D-036-2010
CODE
Lot # 1927440, Exp 06/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ranbaxy, Inc., Princeton, NJ, by letters on October 27, 2009. 
Manufacturer: Ranbaxy Laboratories, Limited, Simour District, India. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Out of Specification results for methylparaben and butylated hydroxyanisole (BHA) for one lot of SOTRET (isotretinoin) Capsules, 40 mg.
VOLUME OF PRODUCT IN COMMERCE
4,348 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Complete-RF Prenatal, Prenatal Multivitamin/Multimineral Tablets, 90 tablets, Rx only, NDC 13811-008-90. Recall # D-043-2010;

2) Trinatal Rx1 (one tablet daily), Prenatal Multivitamin/multimineral Tablet, Rx only, NDC: 13811-007-10, 100 Tablets. Recall # D-044-2010
CODE
1) Lot # 86264, Exp 4/2011;
2) Lot # 86265, Exp. 5/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: TRIGEN Laboratories, Inc., Sayreville, NJ, by letters and e-mail on October 21, 2009.
Manufacturer: Phoenix Labs Rising LLC, Farmingdale, NY. Firm initiated recall is ongoing. 
REASON
Tablet printed with incorrect ID; The imprint coding on the tablets of Trinatal Rx1 vitamins are incorrectly identified as Complete - RF Prenatal vitamins.
VOLUME OF PRODUCT IN COMMERCE
1) 617 bottles; 2) 133 bottles 
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Advanced Listerine with Tartar Protection (eucalyptol 0.092%, menthol 0.042%, methyl salicylate 0.060%, thymol 0.064%), Antiseptic, Arctic Mint, 500 ml bottles, UPC number 312547429252. Item number 42925. Recall # D-045-2010
CODE
Lot number 1749LZ exp 5/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Johnson & Johnson Consumer Group of Companies, Inc., Skillman, NJ, by letter dated October 23, 2009.
Manufacturer: McNeil PPC, Inc., Lititz, PA. Firm initiated recall is ongoing.
REASON
Mislabeled - incorrect back label.
VOLUME OF PRODUCT IN COMMERCE
1000 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0007-10
CODE
Unit: 19GY71399
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by facsimile and by letter dated June 29, 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
TN
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-0010-10
CODE
Unit: 72K736077
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on June 23, 2009 and by telephone on July 30, 2009. 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 
Red Blood Cells Leukocytes Reduced. Recall # B-0011-10
CODE
Unit: W117009173920
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on April 27, 2009 and by letter dated April 28, 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
CA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Irradiated. Recall # B-0013-10
CODE
Unit: W043209003424
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by telephone on June 8, 2009. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0028-10
CODE
Unit: W045009012787
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, by letter dated May 22, 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
MO
__________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0029-10
CODE
Units: W071209017348 (2 units)
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on May 15, 2009 and by letter dated My 18, 2009. Firm initiated recall is complete.
REASON
Blood products, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0031-10
CODE
Units: 4159152, 3998108, 3974071
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by e-mail on March 17, 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
3 units
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0042-10
CODE
Unit: 4391558
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter dated July 3, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received insulin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0063-10
CODE
Unit: Y135982
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by facsimile on March 2, 2005. 
Manufacturer: Puget Sound Blood Center and Program, Lynnwood, WA. Firm initiated recall is complete. 
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT         
1) Red Blood Cells, Leukocytes Reduced. Recall # B-0077-10;
2) Platelets, Leukocytes Reduced. Recall # B-0078-10
CODE
1) and 2) Unit: 13FC69931
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on May 2, 2006 and follow-up letter dated May 26, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI, TX
___________________________________
PRODUCT 
Red Blood Cells (Aphaeresis), Leukocytes Reduced. Recall # B-0086-10
CODE
Unit: 13KZ17992 (Part 1 and Part 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on April 10, 2008 and follow-up letter dated April 29, 2008. Firm initiated recall is complete.
REASON
Blood products, in which quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI

___________________________________
PRODUCT 
Pyrotell Single test Vial (STV) Limulus Amebocyte Lysate(LAL), Sensitivity,125 EU/mL Catalog Number: GS125. Recall # B-0177-10
CODE
Lot Numbers: S08511, S07491
RECALLING FIRM/MANUFACTURER
Associates of Cape Cod, Inc., East Falmouth, MA, by telephone and follow-up letter on July 8, 2009 and September 29, 2009. Firm initiated recall is ongoing.
REASON
Pyrotell Single Test Vials, mislabeled with lot number and sensitivity, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,790 packs
DISTRIBUTION
United Kingdom, Korea
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-0178-10
CODE
Units: 041GM69478 Part 1 and Part 2
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Douglasville, GA, by telephone on October 22, 2007 and follow up letter on October 30, 2007. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specification, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT 
Source Plasma. Recall # B-0225-10
CODE
Units: 4550017320, 4550017138, 4550017709, 4550021796, 4550020592, 4550020213, 4550020021, 4550019610, 4550019050, 4550018877, 4550018511, 4550018304, 4550017920
RECALLING FIRM/MANUFACTURER
Life Sera, Inc., Columbia, SC, by facsimile and e-mail on April 28, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not receive a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
Canada, NC
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-0226-10;
2) Recovered Plasma. Recall # B-0227-10 
CODE
1) and 2) Unit: 003FM09942
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern Region, Douglasville, GA, by facsimile on December 10, 2008 and January 28, 2009 and by letter dated January 28, 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
GA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-0229-10 
CODE
Units: 012GW33331 (Parts 1 & 2), 012GW33337, 012GW33341 (Parts 1, 2, & 3)
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by facsimile on April 10, 2009 and by letters dated April 15, 2009 and May 25, 2009. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma. Recall # B-0231-10
CODE
Unit: 09SMNA0333
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Saint Cloud, MN, by facsimile on April 6, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not receive a complete physical examination, was distributed.  
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Pheresis Leukocytes Reduced. Recall # B-0232-10
CODE
Unit: W270109302094
RECALLING FIRM/MANUFACTURER
Central Pennsylvania Blood Bank, Hummelstown, PA, by telephone on May 9, 2009 and by letter dated August 21, 2009. Firm initiated recall is complete.
REASON
Blood product, which exceeded the maximum criteria for platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0233-10
CODE
Unit: W0352091552595
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX, by facsimile on July 8, 2009 and by letter dated July 10, 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
TX

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Source Plasma. Recall # B-0005-10
CODE
Unit: DU0671583
RECALLING FIRM/MANUFACTURER
DCI Plasma Center of Duluth, LLC, Duluth, MN, by facsimile on May 15, 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
United Kingdom
____________________________________
PRODUCT 
Recovered Plasma, Recall # B-0008-10
CODE
Unit: 19GY71399
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by facsimile and by letter dated June 29, 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 
Red Blood Cells Leukocytes Reduced. Recall # B-0009-10
CODE
Unit: W045009055307
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, by telephone on June 11, 2009. Firm initiated recall is complete.
REASON
Blood product, manufactured without the entire quantity of additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MO
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-0043-10;
2) Fresh Frozen Plasma. Recall # B-0044-10;
3) Platelets. Recall # B-0045-10
CODE
1), 2) and 3) Unit: W035209133877C
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX, by telephone on June 17, 2009 and by letter dated July 10, 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
3 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
1) BOOSTRIX INJ. SUSP., Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed, 10 x 0.5ML Disposable Prefilled Tip-Lok" Syringes, NDC #58160-842-11. Recall # B-0141-10;

2) Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed, Rx only, 5 x 0.5ML Disposable Prefilled Tip-Lok" Syringes, For Adolescent Use Only, Rx only, NDC #58160-842-46. Recall # B-0142-10;

3) CROFAB INJ. 1GM 2VIAL, NDC #0281-0330-10, SAVAGE LABS. Recall # B-0143-10;

4) DIGIFAB 40MG, NDC #0281-0365-10, SAVAGE LABS. Recall # B-0144-10;

5) ENGERIX-B, HEPATITIS B VACCINE (RECOMBINANT), 10MCG/0.5ML 10X0.5ML Single Dose Vials, Rx only, NDC #58160-820-11. Recall # B-0145-10;

6) GARDASIL INJECTION [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant], 0.5ML Single Dose Vials, Rx only, NDC #0006-4045-00. Recall # B-0146-10;

7) GARDASIL INJECTION [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant], 10X0.5ML Single Dose Vials, Rx only, NDC #0006-4045-41. Recall # B-0147-10;

8) GARDASIL INJ. 6X0.5ML PF, NDC #0006-4109-06. Recall # B-0148-10;

9) HAVRIX HEPATITIS A VACCINE INACTIVATED INJECTION SOLUTION, 1440ELU/ML 10X1ML, Single Dose Vials, For Adult Use Only, Rx only, NDC #58160-826-11. Recall # B-0149-10;

10) HAVRIX HEPATITIS A VACCINE INACTIVATED INJECTION SOLUTION, 1440ELU/ML 5X1ML, Disposable Prefilled Tip-Lok Syringes, For Adult Use Only, Rx only, NDC #58160-826-46. Recall # B-0150-10;

11) HAVRIX HEPATITIS A VACCINE INACTIVATED, 720ELU 5X0.5ML, Disposable Prefilled Tip-Lok Syringes, Rx only, For Pediatric/Adolescent Use Only, NDC #58160-825-46. Recall # B-0151-10;

12) HEPATITIS B VACCINE ENGERIX B, FOR ADULT USE ONLY 20MCG/ML 5X1, Single dose vials, Rx only, NDC #58160-821-46. Recall # B-0152-10;

13) HEPATITIS B VACCINE ENGERIX B, FOR ADULT USE ONLY 20MCG/ML10X1ML, NDC #58160-821-11, Single dose vials, Rx only. Recall # B-0153-10;

14) INFANRIX INJECTION, Diphtheria and Tetanus toxoids and Acellular Pertussis Vaccine Adsorbed, 10X0.5ML, Single-Dose Vials, Rx only, NDC #58160-840-11. Recall # B-0154-10;

15) KINRIX" INJECTION SUSPENSION (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adorbed and Inactivated Poliovirus Vaccine, 10X0.5ML, Single Dose Vials, Rx only, NDC #58160-812-11. Recall # B-0155-10;

16) MERUVAX II (Wistar RA 27/3 Strain), RUBELLA VIRUS VACCINE LIVE, 10 Single Dose Vials, Rx only, NDC #0006-4673-00. Recall # B-0156-10;

17) M-M-R II MEASLES, MUMPS, AND RUBELLA VIRUS VACCINE LIVE, 0.5MLX10 SINGLE-DOSE VIAL, Rx only, NDC #0006-4681-00. Recall # B-0157-10;

18) NABI-HB Hepatitis B Immune Globulin (Human), Solvent/Detergent Treated and Filtered, For Intramuscular Administration Only, 312U/ML 1ML, Rx only, NDC #59730-4202-1. Recall # B-0158-10;

19) NABI-HB Hepatitis B Immune Globulin (Human), Solvent/Detergent Treated and Filtered, For Intramuscular Administration Only, 312U/ML 5ML, Rx only, NDC #59730-4203-1. Recall # B-0159-10;

20) PEDIARIX SOLUTION INJECTION, [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined], 10X0.5ML Single Dose Vials, Rx only, NDC #58160-811-11. Recall # B-0160-10;

21) PEDIARIX SOLUTION INJECTION, [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined], 5X0.5ML DISPOSABLE PREFILLED TIPLOK SYRINGES, Rx only, NDC #58160-811-46. Recall # B-0161-10;

22) PNEUMOVAX, 23, Pneumococcal Vaccine Polyvalent, 25MCG 10X0.5ML, NDC #0006-4943-00. Recall # B-0162-10;

23) PNEUMOVAX, Pneumococcal Vaccine Polyvalent, For Syringe Use Only, 23 x 5MCG/0.5ML 2.5ML, NDC #0006-4739-00. Recall # B-0163-10;

24)  RECOMBIVAX HB, Hepatitis B Vaccine {Recombinant], Adult Formulation, 10MCG/ML 10 Single Dose X 1ML Vials, NDC #0006-4995-41. Recall # B-0164-10;

25) RECOMBIVAX HB, Hepatitis B Vaccine [Recombinant], Adult Formulation, 10MCG/ML 1 Dose 1ML Vial, Rx only, NDC #0006-4995-00. Recall # B-0165-10;

26) RECOMBIVAX HB, Hepatitis B Vaccine [Recombinant], Adult Formulation, 10MCGML 6 Single Dose X 1ML Syringes, with separate 1 needle, Rx only, NDC #0006-4094-06. Recall # B-0166-10;

27) RECOMBIVAX HB, Hepatitis B Vaccine [Recombinant], Dialysis Formulation, 40MCG/ML 1 Dose X 1ML Vial, NDC #0006-4992-00. Recall # B-0167-10;

28) RECOMBIVAX HB, Hepatitis B Vaccine [Recombinant], Pediatric/Adolescent, 5MCG/0.5ML10Single Dose 0.5mL Vials, Rx only, NDC #0006-4981-00. Recall # B-0168-10;

29) REGRANEX GEL 0.01% (becaplermin), 15GM TUBE (For Topical Use Only, NDC #0045-0810-15. Recall # B-0169-10

30) RHOGAM, RHO (D) IMMUNE GLOBULIN (HUMAN) ULTRA-FILTERED PLUS, 300MCG 25, NDC #0562-7805-25. Recall # B-0170-10;

31) RHOGAM, RHO (D) IMMUNE GLOBULIN (HUMAN) ULTRA-FILTERED PLUS, 300MCG 5, NDC #0562-7805-05. Recall # B-0171-10;

32) RHOGAM, RHO (D) IMMUNE GLOBULIN (HUMAN) ULTRA-FILTERED PLUS, 300MCG Dose (1500IU), (For Intramuscular Use Only), Rx only, NDC #0562-7805-01.  Recall # B-0172-10;

33) ROTATEQ, ROTAVIRUS VACCINE, LIVE, ORAL PENTAVALENT, For Oral Use Only, Not for Injection, 10 Single-Dose X 2M LUD TUBE, Rx only, NDC #0006-4047-41. Recall # B-0173-10;

34) TWINRIX, Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine, 20MCG-720ELU/ML, 10 X 1ML Single-Dose Vials, For Adult Use Only, NDC #58160-815-11. Recall # B-0174-10;

35)  TWINRIX, Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine, 5 Disposable Prefileld Tip-Lok Syringes each containing one 1ML dose, For Adult Use Only, Rx only, NDC #58160-815-46. Recall # B-0175-10;

36) VIVOTIF Typhoid Vaccine Live Oral Ty21a (for oral, active immunization against typhoid fever), Rx only, NDC #58337-0003-1. Recall # B-0176-10
CODE
1) Lot Number: AC52B020AA;

2) Lot Numbers: AC52B024DB and AC52B028AA;

3) Lot Number: BN20;

4) Lot Number: BN200874 and BN200788C;

5) Lot Numbers: AHBNB659BA, AHBVB659BA, AHBVB659AA, AHBVB659BA, AHBVB674BA and AHBVB647BA;

6) Lot Numbers: 0546X and 0847X;

7) Lot Numbers: 0843X, 0571X and 0548X;

8) Lot Numbers: 0573X and 0947X;

9) Lot Number: AHAVB252AA;

10) Lot Numbers: AHVAB251CA, AHABV251BA, AHAVB251BA and AHAVB251CA;

11) Lot Numbers: AHAVB280AA, AHAVB284AA, AHAVB284CA, AHAVB284DA, AHAVB289BA, AHAVB289CB, AHAVB291AA, AHAVB291CA, AHAVB292AA, AHAVB268EA, AHAVB268DA, AHAVB264AA, AHAVB320AA, AHAVB297CA, AHAVB319AA, AHAVB309AA, AHAVB320BA, AHAVB624AA, AHAVB297AA, AHAVB289AA and AHAVB294BA;

12) Lot Numbers: AHBVB640BA, AHBVB540BA and AHBVB640AA;

13) Lot Numbers: AHBVB670AA and AHBVB584AA;

14) Lot Numbers: AC14B065AA and AC14B064AA;

15) Lot Numbers: AC20B116AB and AC20B084BB;

16) Lot Number: 1198X;

17) Lot Numbers: 0931X, 0987X, 1080X, 1208X, 1247X and 1250X;

18) Lot Numbers: 908519 and 909304;

19) Lot Numbers: 907749, 906397, 909304;

20) Lot Numbers: AC21B167AA, AC21B150AA and AC21B173AA;

21) Lot Numbers: AC21B198BA, AC21B163BC, AC21B192BA, AC21B192CA, AC21B192DA, AC21B201AA and AC21B198AA;

22) Lot Numbers: 0619X, 0869X, 0612X, 0614X, 021X, 0978X, 0868X, 1295X, 0813X, 0724X, 0725X, 0742X, 0743X, 0551X, 0669X,and 0224X;

23) Lot Numbers:0619X, 0224X, 0619X,1679U, 0867X, 0551X, 0224X and 0868X;  

24) Lot Numbers: 0396X, 0398X, 0838X, 0866X and 0126X;

25) Lot Numbers: 0399X and 0866X;

26) Lot Numbers: 0757U and 1040X;

27) Lot Numbers: 0757U, 1040X, 0866X and 0724X;

28) Lot Numbers: 0026X, 0725X, 0610X, 1719U, 0599X, 0601X, 0401X and 0062X;

29) Lot Numbers: L003 and L004;

30) Lot Numbers: RVP113A1, RVP110A1, RVP112A1, RVP116A1 and RVP115A1;

31)  Lot Number: RVP113A1;

32) Lot Numbers: RVP109A1, RVP110A1, RVP112A1 and RVP116A1;

33) Lot Numbers: 0469X, 0894X, 0502X, 0964X, 0467X and 0594X;

34) Lot Number: AHABB140AA;

35)  Lot Numbers: HABB128AB, AHABB132CC, AHABB132AC and AHABB132AA;

36) Lot Number: 5833700031
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health Care, McDonough, GA, by telephone beginning November 6, 2008 and by letter on November 13, 2008 by fax, e-mail or mail.
Manufacturer: Merck & Co, Inc., Whitehouse Station, NJ. Firm initiated recall is complete. 
REASON
Products, whose stability may have been compromised due to defective refrigeration unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
145 units
DISTRIBUTION
AL, GA, MO, MS, SC, TN and WV
___________________________________
PRODUCT 
Source Plasma. Recall # B-0230-10
CODE
Units: 3870017730, 3870016762, 3870016636, 3870078716, 3870069832, 3870069230, 3870068436, 3870066901, 3870026539, 3870026041, 3870018748, 3870067630, 3870018007
RECALLING FIRM/MANUFACTURER
International BioResources LLC, Springfield, IL, by a customer form on April 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
13 units
DISTRIBUTION
Austria

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT 
1) GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150" long x 87" wide. Recall # Z-1706-2009;

2) Sterile, Drape, Headset, Upper, Part Number 888945-01. Recall # Z-1708-2009;

3) Sterile, Drape, Headset, Upper, Part Number 888945-01. Recall # Z-1708-2009;

4) Disposable Pack, Headset Part Number 888946-01(kit includes Part Number 888944-01, Sterile, Drape, Headset, Lower and Part Number 888945-01, Sterile, Drape, Headset, Upper). Recall # Z-1709-2009
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated August 15, 2008.   
Manufacturer: Contour Fabricators Inc., Fenton, MI. Firm initiated recall is ongoing.
REASON
Products may have seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state.
VOLUME OF PRODUCT IN COMMERCE
2,850 units
DISTRIBUTION
AZ, CA, FL, MD, NY, OR, PA, SC and TX
___________________________________
PRODUCT 
Broselow/Hinkle Pediatric Emergency System; Contents: 1 15 Ga Adjustable Length Sternal/Iliac aspiration Needle; 1 Extension Set, Sterile. Equipment Color Zone: Green, Single Patient use, INTRAOSSEUS Module, Product # 7700GIO, The Broselow/Hinkle Pediatric Emergency System is a convenience kit that contains various modules/components used for the emergency treatment of pediatric patients. The modules are color coded to accommodate patients of various sizes. Model Numbers: 7700BIO, 7700GIO, 7700PIO, 7700RIO, 7700WIO, 7700YIO, 7700BIO2, 7700GIO2, 7700OIO2, 7700PIO2, 7700RIO2, 7700WIO2, 7700YIO2, 7730BLU5, 7730GRN5, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5, 7730FLY, 7730MOD, 7730ALS and 7730IALS. Recall # Z-1912-2009
CODE
Lot Numbers: (2008) 245F through 366F and (2009) 001K through 149K
RECALLING FIRM/MANUFACTURER
Vital Signs, Inc., Totowa, NJ, by letter dated June 30, 2009. Firm initiated recall is ongoing.
REASON
Not compatible: The luer connector on the Intraosseus needle provided does not fit securely on the luer connection of the IV Extension Set in the module.
VOLUME OF PRODUCT IN COMMERCE
23,429 units
DISTRIBUTION
Nationwide, Canada, United Arab Emirate, Venezuela, Guam, Korea and United Kingdom
___________________________________
PRODUCT 
ACT3020 Advanced Cutting technology (ACT) Twist Drill 3.0mm(D) X 20mm(L).. Made in Switzerland. Twist drill for preparation of osteotomy during dental implant surgical drilling procedure. Recall Z-1947-2009
CODE
Lot # 860172 
RECALLING FIRM/MANUFACTURER
Recalling Firm: BIOMET 3i LLC, Palm Beach Gardens, FL, by telephone, fax and letter, dated June 30, 2009.
Manufacturer: Dentsply Maillefer, Ballaigues, Switzerland. Firm initiated recall is ongoing.
REASON
Some of the packages of ACT3020, drills may actually contain an ACT3220 drill.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
Nationwide, Korea, Netherlands, Taiwan, United Kingdom
___________________________________
PRODUCT 
Celsite Access Port Model ST305P. The Celsite Access Port model ST305P is a member of the Celsite product line of implantable port and catheter systems. Recall # Z-1961-2009
CODE
Lot Numbers: H3238310 and I0059950
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Interventional Systems, Plymouth, MN, by letter dated June 22, 2009.
Manufacturer: B.Braun Celsa Medical, Chasseneuil, France. Firm initiated recall is ongoing.
REASON
B. Braun Interventional Systems was notified by B. Braun Medical France, the manufacturer of the Celsite Access port that they had received 11 reports of polyurethane (type P) catheter disconnections. B. Braun Medical France has decided to recall all Celsite ports supplied with the affected catheter lot. To date, B. Braun Interventional Systems (US) has not received any reports of catheter disconnections. Nevertheless, B. Braun Interventional Systems (BIS) has decided to recall the above identified Celsite port systems, which were manufactured with the affected catheter lot, as a precautionary measure.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04. Recall # Z-1965-2009
CODE
Lot Number: A07D02B
RECALLING FIRM/MANUFACTURER
Theken Spine LLC, Akron, OH, by telephone on August 26, 2008. Firm initiated recall is ongoing.
REASON
Failure to label the product properly. Additionally, 15 pieces were reworked and the expiration date was misprinted as 2011-04 instead of the actual date of 2010-04.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
1) Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients. Recall # Z-1994-2009;

2) Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients. Recall # Z-1995-2009
CODE
1) Serial Numbers: 5200343 5213853 6078828 6086647 4472924 4472925 4664493 4664494 4664495 4667153 4667154 4667155 4667156 4667157 4667158 4667159 4667160 4667161 4667162 4667163 4667164 4667165 4667166 4667167 4667168 4667169 4667170 4667171 4686625 4686626 4686627 4686628 4686629 4686632 4818712 4818713 4919915 6019724 6021710 6021719 6021720 6021721 6021723 6021724 6021726 6021727 6021728 6021729 6021731 6021734 6022892 6022894 6022895 6022899 6022913 6022914 6022915 4474270 4474271 4474272 4474273 4474274 4474275 4474276 4474278 4474279 4474280 4475208 4475209 4475210 4475211 4501837 4477170 4220901 4477163 4477164 4477165 4477166 4477167 4477171 4477172 4477173 4477174 4477175 4477176 4477177 4477178 4477179 4477181 4477182 4477183 4686630 4686631 4686633 4022924 4022925 4286331 4286332 4477169 4474277 6024987 6026814 6026815 6026816 6056122 6056127 6056128 6056129 6056130 6056131 6056132 6056133 6056143 6056151 6061289 6061291 6078795 6094682 6094683 6094684 6094685 6094686 6094687 6094708 6047448 6047492 6064261 6068684 6068904 6072656 6072661 6072662 6072663 6072665 6072666 6072667 6072671 6081978 6081981 6081986 6081987 6081988 6081990 6081991 6081992 6081993 6024986 6026803 6026817 6043512 6043513 6043514 6043517 6043521 6043522 6043523 6043525 6043527 6043528 6043529 6043530 6043531 6045149 6048560 6048562 6048564 6048565 6048566 6048567 6056144 6056145 6056146 6056148 6056152 6056153 6056157 6061300 6061308 6061309 6067551 6071851 6071852 6071853 6071854 6021739 6025282 6025285 6025286 6025289 6038998 6040158 6040174 6040175 6041237 6041240 6043926 6043954 6064262 6064264 6064265 6064268 6064272 6064280 6064283 6064286 6064292 6068701 6068707 5193558 6026810 6026811 6026813 6043516 6043518 6043519 6067535 6067557 6106238 6106259 6106261 6106273 6109063 6109066 6109068 6094675 6094676 6094677 6094678 6094679 6094680 6103456 6045217 6045225 6045226 6045227 6048549 6048558 6056137 6061293 6097899 6034107 6036892 6105213 6105214 6105216 6105218 6105221 6105223 6105225 6047437 6047441 6047444 6047450 6047452 6047456 6047457 6047460 6064270 6064271 6064273 6064278 6097924 6026806 6026809 6097013 6067532 6067533 6067536 6067554 6067555 6109133 6109147 6043947 6043967 6043515 6056123 6056124 6056125 6056126 6056141 6056142 6056150 6034105 6034118 6068879 6068881 6068883 6068885 6068888 6068906 6068915 6068924 6072245 6021713 6024705 6028031 6028052 6041222 6081999 6061290 6094681 5213856 5213858 5213862 5216681 5219299 5219302 5188822 5191233 5191236 5191237 5191240 5191242 5193481 5193550 5193559 5197177 5197178 5197197 5197915 5200361 5200389 5200391 5216679 6024979 6024980 6024981 6024982 6024983 6024984 6024985 6024988 6071855 6071857 6071858 6071859 6071860 6071862 6071863 6071864 6078808 6078809 6078810 6078812 6078813 6078816 6078823 6078824 6078829 6086655 6034116 6034120 6036885 6036917 6036934 6038954 6038956 6038957 6038958 6038987 6064257 6068902 6068912 6068914 6068920 6072247 6082009 6082015 6082033 6083406 6083418 6083421 6083431 6083436 6083440 6083445 6083448 6083449 6083450 6083452 6083456 6026804 6026805 6061287 6061294 6061297 6061298 6086636 6086638 5188879 5191235 5191238 5193535 5200348 5200382 5216674 5216686 6056134 6061301 6078798 6078799 6078801 6078821 6018852 6022904 6023362 6023366 6023368 6023375 6023377 6023381 6024715 6024716 6024717 6024723 6024724 6024728 6024729 6083411 6083420 95001137 5191247 6095174 6097898 6097900 6006403 6007930 6019536 6019537 6019540 6019550 6021707 6021717 6021718 6021735 6021736 6021737 6022587 6022890 6023357 6082016 6034139 6036926 6038945 6097913 6103457 6103458 6105220 6105227 6105228 6105233 6105234 6105235 6105236 6105238 6105240 6105242 6105243 6026807 6026808 6045208 6045210 6045211 6045212 6045213 6045214 6045215 6045216 6045218 6045219 6045220 6045221 6045223 6048550 6048551 6048554 6087692 6087706 6087711 6087714 6087715 6087720 6091612 6091622 6094667 6106239 6106262 6106269 6106271 6109074 6025268 6026696 6026697 6026698 6026701 6028037 6028045 6028048 6028049 6028050 6034127 6034134 6034138 6036935 6036937 6038942 6038959 6038968 6038977 6038979 6038985 6038997 6040169 6041261 6043927 6043937 6043943 6043946 6043948 6043953 6043970 6067769 6067772 6026812 6043524 6043526 6045209 6048568 6056119 6056120 6056121 6056154 6056155 6056156 6056158 6042820 6042821 6042822 6042823 6050766 6050769 6050770 6050772 6050773 6050775 6050777 6050779 6051937 6052006 6052009 6064224 6085509 6085511 6085512 6095401 6095403 6095405 6095417 6095418 6095423 6095424 6095425 6095775 6095777 6095778 6095786 6095790 6097008 6103387 6103391 6103392 6103393 6103394 6103395 6103398 6103399 6103400 6023370 6024730 6036890 6036894 6036896 6036903 6095169 6095170 6095171 6095181 6095182 6097892 6063552 6063554 6067534 6067537 6067538 6067539 6067543 6067544 6067545 6067553 6071856 6071861 6078818 6086649 6094674 6036895 6036897 6036898 6041216 6041232 6041242 6041257 6043920 6043922 6043928 6043933 6043934 6043935 6043936 6043938 6043939 6043940 6043942 6043944 6043945 6043966 6043968 6043973 6043976 6043978 6043979 6047433 6047434 6064241 6064253 6072668 6072672 6072675 6072698 6072699 6072705 6081977 6095141 6095143 6095154 6095180 6097889 6097894 6097897 6097904 6097908 6068700 6086629 6086630 6086631 6086634 6086637 6094664 6071871 6071875 6078802 6078804 6078805 6067548 6072253 5188859 5193542 5197198 5200359 5200379 5200392 5216684 6025280 5188881 5191239 5193508 5197190 5200349 5200366 5213854 5213855 5213857 5216689 5219288 5219297 6071865 6071867 6071868 6071869 6071870 6071872 6071873 6071876 6071877 6078803 6078825 6078827 6086656 6086657 6015580 6015581 6015582 6015583 6015584 6015589 6018405 6018406 6018409 6018412 6018434 6019525 6019526 6019528 6019530 6019531 6068893 6068925 5216677 5219291 5219306 6047479 6047489 6082001 6083434 6087684 6087696 6087698 6087699 6087700 6087701 6087702 6087704 6087705 6087707 6087709 6087710 6087719 6087723 6087724 6087725 6087726 6087727 6089222 6089223 6089505 6089506 6089507 6089508 6089509 6089510 6089511 6089512 6089514 6089515 6089516 6089518 6089520 6089521 6089522 6089523 6089526 6089527 6089530 6089533 6089535 6089537 6089557 6021738 6021740 6023356 6024731 6024732 6024734 6025271 6025273 6025281 6025283 6025284 6026708 6026716 6026718 6026721 6028041 6028056 6034121 6034122 6034126 6034132 6034157 6036883 6036887 6036939 6036940 6038948 6038994 6039001 6040156 6040157 6040161 6040164 6040165 6040166 6040167 6040171 6040172 6040176 6040177 6040178 6040179 6040180 6040182 6040183 6040184 6040185 6040186 6040188 6040190 6040191 6040192 6040193 6040194 6040195 6040197 6041205 6041206 6041207 6041208 6041211 6041218 6041223 6041231 6041248 6041249 6041252 6041258 6041259 6043925 6043941 6043950 6043962 6043965 6078792 6086646 6086648 6097917 6103422 6103434 6103439 6103441 6103442 6103446 6103447 6103448 6103452 6024727 6068868 6068870 6068910 6068913 6078800 6078811 6078814 6078815 6078817 6078819 6064294 6083414 6097926 6103410 95001937 95002143 6051935 6051936 and 6052000;

2)  Serial Numbers: 5128889 5128890 5128891 5128892 5128893 5128894 5128895 5128896 5128897 5128898 5128899 5128900 5128901 5128902 5128903 5128904 5128905 5128906 5128907 4477168 4664492 4664501 4664502 4664503 4664504 4895486 4941851 4933633 4933634 4933635 5123856 5123857 5123858 5123859 5123860 6091772 6091793 6091798 6091808 6091810 6091812 6091815 4677835 4686814 4686815 4801836 4933640 4933641 4501834 4501835 4677816 4851329 4851330 4851331 4851332 4851333 4851334 4851335 4851336 4479683 4895480 4895481 4895482 4895483 5148283 5148284 5148285 5148286 5148287 4477184 4477185 4477186 4477187 4477188 4477189 4477190 4477191 4477192 4477193 4477194 4477195 4477196 4477198 4477199 4477200 4477201 4477972 485135 4290001 4695833 4695834 4695835 4695836 4851358 4851359 4851360 4933632 5186416 5186417 5186418 5128888 5195464 6063039 6063073 6063074 6063075 6063078 6063170 6063171 6063172 6063173 6063176 6063177 6063178 6063104 6063107 6091814 6098549 6091788 6033273 6029184 6033292 6034325 6071339 6098570 6098572 6098635 6098636 6080649 6080652 6024822 6080714 6080726 6080737 6086854 6086857 6086862 6091801 6091806 6108988 6026830 6026832 6080728 6080731 6080733 6080743 6080748 6080756 6080762 6009191 6108972 6108975 6063072 6086922 6086933 6091754 6091697 6091699 6091705 6091713 6091714 6108949 6108980 6108981 6032063 6034393 6034394 6034408 6080648 6080651 6087043 6087044 6087046 6087047 6091693 6091824 6098543 6098551 6098683 6098684 6108924 6056086 5218184 6017219 6071349 6080736 6080750 6108991 6071424 6086924 6086926 6086927 6086935 6086948 6098658 6003166 6009180 6009181 6009182 6009183 6009184 6009185 6009186 6009187 6009188 6009189 6009192 6009193 6013447 6013450 6013451 6013453 6013454 6013458 6013459 6015390 6015393 6015394 6015395 6028333 6028341 6028346 6032084 6032086 6032087 6032088 6032090 6032093 6032094 6032096 6032097 6032098 6032099 6032101 6032102 6032104 6032091 6034356 6041888 6041899 6041901 6041919 6041921 6041930 6047589 6047590 6047591 6071351 6071353 6071355 6071358 6098672 6098682 6098690 6108923 6108926 6108950 6108953 6108965 6017274 6026822 6028316 6032069 6032112 6032116 6032118 6033246 6034335 6034337 6034340 6034341 6034342 6034346 6034347 6034359 6056043 6056047 6056048 6056051 6063053 6086881 6086898 6086900 6086902 6086919 6091741 6108968 6108969 6108970 6108973 6017276 6017278 6024825 5224920 6056097 6063046 6063047 6063050 6063051 6063052 6063055 6063056 6063065 6063100 6063179 6071365 6071366 6071368 6071370 6071371 6071373 6071374 6071375 6071376 6071377 6071378 6071379 6071380 6071381 6071383 6071384 6071385 6071387 6071389 6071391 6071392 6071393 6071394 6071395 6071401 6071402 6071404 6071406 6071407 6071408 6071413 6071429 6076860 6076861 6076863 6033255 6041868 6041895 6041915 6041917 6098562 6098563 6098564 6098568 6098571 6098585 6098586 6098589 6098591 6098594 6098602 6098606 6098624 6098625 6098626 6098627 6098628 6098629 6098631 6098632 6098633 6098653 6098656 6098662 6098664 6029194 6029195 6029207 6029209 6091773 6091785 6091786 6091787 6091789 6091790 6091792 6091794 6091795 6091796 6091799 6091802 6091804 6091805 6091807 6091816 6091817 6091818 6091819 6091820 6091821 6091822 6091828 6098552 6098553 6063092 6098565 6098581 6098582 6098584 6098588 6098590 6098592 6098593 6098597 6098600 6098603 6098604 6091777 6063081 6063084 6063101 6063102 6063103 6080751 6080766 6080770 6091734 6091740 6091742 6091748 6091770 6098691 6108982 6108992 6034355 6080637 6080639 6080664 6080666 6080673 6080675 6091726 6091728 6091730 6091737 6091743 6091744 6091745 6091746 6091747 6056117 6063066 6063114 6086904 6086906 6108947 6108948 5211153 6034403 6086973 6087001 6087026 6087033 6087040 6032076 6071433 6091765 6091780 6091784 6098673 6032075 6032077 6063111 6071316 6071326 6071327 6071328 6071329 6071332 6071333 6071334 6071335 6071336 6071337 6071341 6071343 6071434 6071435 6071436 6071437 6071438 6098670 6098671 6098675 6098677 6098678 6098679 6086938 6086974 6086975 6086976 6086978 6086994 6047570 6056110 6056116 6063049 6063174 6086941 6091685 6091722 and 6091729
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems Information Tecnology, Wauwatosa, WI, by letter dated February 6, 2006.   
Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. Firm initiated recall is ongoing.   
REASON
GE Healthcare (Datex-Ohmeda) S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software had an issue where the Heart Rate (HR) was displaying as ---(3 dashes) when the monitor was used continuously for 49 days without a cold start. A missed alarm or missed HR value could cause a delay in recognition of a cardiac event that may result in a serious injury that is permanent or life threatening. There were no reported patient injuries or illnesses for the use of this device in conjunction with this device correction.
VOLUME OF PRODUCT IN COMMERCE
1,380 units
DISTRIBUTION
Italy, Australia, Austria, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Israel, Jordan, Lithuania, Italy, Macedonia, Malaysia, Mexico, Netherland, Nicaragua, Norway, Poland, Portugal, Puerto Rico, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Syria, Turkey, United Arab Emirates, United Kingdom, Venezuela
___________________________________
PRODUCT 
Ultra-Thin LightMat Surgical Illuminator, Disposable one time use. Model Number: UA2550, Exp Date: 2012-05. Product is packaged in individual sterile pouch w/5 pouches per box. The LightMat is intended for the illumination of surgical procedures, particularly where deep cavities or adjacent tissues limit outside light in the surgical field. Recall # Z-1998-2009
CODE
Lot Number: I01161
RECALLING FIRM/MANUFACTURER
Lumitex, Inc., Strongsville, OH, by letter dated July 2, 2009. Firm initiated recall is ongoing.
REASON
Adhesive which is used to attach LightMat to retractor may not have been tested to Medical standards. The vendor provided an adhesive strip that did not conform to Lumitex specifications. The adhesive strip provided may not have met Lumitex requirements to be medical grade, EtO compatible, and biocompatible.
VOLUME OF PRODUCT IN COMMERCE
59 boxes/5 individual pouches containing 1 unit
DISTRIBUTION
CA, FL, KS, MA, ME, MI, NC, NM, NV, NY, OH, and TX
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PRODUCT 
1) Roche Coaguchek XS System, Coaguchek XS Professional Care Kit; Catalog/Model Number 04837975001. Coaguchek XS System and Coaguchek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication. Recall # Z-2002-2009;

2) Roche Coaguchek XS System, Coaguchek XS PST Kit; Catalog/Model Number 04837738001. Coaguchek XS System and Coaguchek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication. Recall # Z-2003-2009;

3) Roche Coaguchek XS System, Coaguchek XS Plus Care Kit; Model Number 05021537001. Coaguchek XS System and Coaguchek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication. Recall # Z-2004-2009
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Operations, Inc., Indianapolis, IN, by letter dated July 22, 2009.
Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.
REASON
The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.
VOLUME OF PRODUCT IN COMMERCE
210,000 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT 
Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The Jet Ventilation Catheter allows a safe and atraumatic transtracheal access for oxygenation/ventilation. Recall # Z-2010-2009
CODE
Lot Numbers: P0207409, P0209509, P0211009, P0214009, P0215609, P0301609, P0303109, P0304909, P0306209, P0307909, P0312309, P0400209, P0402409, P0404409, P0405909, P0408509, P0410009, P0412209, P0414209, P0416909, P0506509, P0506509R09, P0507609, P0509709, P0515009, P0602309, P0602809, P0604009, P0604209, P0607009, P0607009, P0607009R09, P0608809, P0612309, P0613709, P0615809, P0617309 and P0619209
RECALLING FIRM/MANUFACTURER
Recalling Firm: Instrumentation Industries, Inc., Bethel Park, PA, by letter dated July 9, 2009.
Manufacturer: Vbm Medizintechnik Vertriebs Gmbh, Sulz A.N., Germany. Firm initiated recall is ongoing.
REASON
User instructions not updated to correspond with product change.
VOLUME OF PRODUCT IN COMMERCE
396 units
DISTRIBUTION
Nationwide
________________________________
PRODUCT 
HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part #811905, Bottle part #1905LB. SteriChek Residual Peroxide Reagent Strips provide a convenient means of measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid. Recall # Z-2016-2009
CODE
Lot Number: A8350; and Lot Numbers: 8350 and 8345
RECALLING FIRM/MANUFACTURER
Hach Co., Ames, IA, by letter dated April 21, 2009 and by telephone between April 22 – 23, 2009. Firm initiated recall is complete.
REASON
Some of the reagent strip bottles contain the incorrect strips.
VOLUME OF PRODUCT IN COMMERCE
275 kits
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

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PRODUCT 
Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP). In vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
Catalog Number DF34. Recall # Z-1930-2009
CODE
Lot Numbers: CE8324 exp 11/19/2008, BA8349 exp 12/14/2008, FB9003 exp1/3/2009, BC9017 exp1/17/2009, EC9021 exp1/21/2009, DB9032 exp2/1/2009, and DC9045 exp2/14/2009
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter on April 15, 2008. Firm initiated recall is complete.
REASON
Falsely elevated results in EDTA plasma samples.
VOLUME OF PRODUCT IN COMMERCE
25,760 cartons
DISTRIBUTION
Nationwide, Austria, Bosnia, Czech Republic, Hungary, Slovakia, Serbia, Denmark, Estonia, Latvia, Lithuania, Norway, Sweden, Belgium, Cyprus, Canary Islands, France, Great Britain, Germany, Ireland, Italy, Netherlands, Poland, Russia, Portugal, Saudi Arabia, Spain, South Africa, Switzerland, Turkey, Yemen, Bahamas, Brazil, Canada, Mexico, Australia, Bangladesh, China, Hong Kong, Japan, Malaysia, Pakistan, and Taiwan

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II

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PRODUCT 
1) Osborn, Spectam (Spectinomycin) Water Soluble Concentrate, Anti-Infective, For Animal Use Only, NADA 038-661, Product No 1SPE001, Net Contents 1000 g (35.27 Oz). Recall # V-007-2010;

2) EXPANDED RECALL: Brand of Lincomycin-Spectinomycin soluble powder, Water Soluble Powder, For use in Chickens only, Antibacterial and Antimycoplasmal. Packaged under the following 2 labels: 1. Agripharm Lincomycin S 50, item number 1LIN022; 2. Bimeda SpecLinx-50, Item Number 1LIN009. This packet contains: Lincomycin hydrochloride Equivalent to lincomycin 16.7 grams, Spectinomycin dihydrochloride pentahydrate, Equivalent to spectinomycin 33.3 grams Total Antibiotic Activity 50.0 grams. Net Weight: 75 g (2.65oz) ANDA 200-380. Recall # V-008-2010
CODE
1) Lot # 54850051;
2) Lot #’s 5436022 (Exp 07/10) and 54360027 (Exp 03/11)
RECALLING FIRM/MANUFACTURER
Bimeda, Inc., Le Sueur, MN, by letter dated May 5, 2009 and August 16, 2009. Firm initiated recall is ongoing.
REASON
Lots were discovered to have high mold counts due to a problem with a particular lot of raw ingredient used to make the products.
VOLUME OF PRODUCT IN COMMERCE
679 Expanded Recall: 14,939
DISTRIBUTION
AL, CA, CO, GA, IA, ID, IN, KS, MI, MN, MO, NC, NE, OH, PA, TN, TX, WI

END OF ENFORCEMENT REPORT FOR NOVEMBER 18, 2009

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