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U.S. Department of Health and Human Services

Safety

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Enforcement Report for June 2, 2010

  June 2, 2010                                                                                        10-21

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT 
1) Spike ORIGINAL Magic Gourmet Natural Seasoning. Sold in the following sized packages: 1. Net. Wt. 3 oz. UPC 0-75820-00000-4; 2. Net Wt. 7 oz., UPC 0-75820-20408-2; 3. Net Wt. 14 oz, UPC 0-75820-20616-1; 4. Net Wt. 5 lb. UPC 0-75820-30030-2. Recall # F-2134-2010;

2) Spike VEGIT Magic Gourmet Natural Seasoning. Sold in the following sized packages: 1. Net Wt. 2 oz. UPC 0-75820-00002-8; 2. Net Wt. 4 oz. UPC 0-75820-20806-6; 3. Net Wt. 8 oz. UPC 0-75820-21012-0. Recall # F-2135-2010;

3) Spike VEGE-SAL Magic Gourmet Natural Seasoning. Sold in the following sized packages: 1. Net Wt. 4 oz. UPC 0-75820-00001-1; 2. Net Wt. 10 oz. UPC 0-75820-15410-3; 3. Net Wt. 20 oz. UPC 0-75820-15222-2. Recall # F-2136-2010;

4) Spike HOT 'n SPICY Magic Gourmet Natural Seasoning. Net Wt 2.5 oz. UPC 0-75820-00005-9. Recall # F-2137-2010;

5) Spike TENDERIZER Magic Gourmet Natural Seasoning. Modern Products. Net Wt. 3-3/4 oz. UPC 0-75820-00003-5. Recall # F-2138-201;

6) Spike ONION Magic Gourmet Natural Seasoning. Modern Products. Net Wt. 2-1/2 oz. UPC 0-75820-00008-0. Recall # F-2139-2010;

7) Gayelord Hauser Instant All Natural Vegetable Broth Modern Products. Sold in the following sized packages: 1. Net Wt. 4 oz. UPC 0-75820-17804-8; 2. Net Wt. 8 oz. UPC 0-75820-18008-9. Recall # F-2140-2010
CODE
1) Date codes / Lot #: 9J19, 9J20, 9J21, 9K12, 9K13,9K16, 9K30, 9L01, 9L03, 9L16, 9L17, 9L21, 9L28, 9L29, 9L30, 10A12, 10A13 10B10, 10B11, 10B12, 10B15, 10B18, 10B25, 10B26;

2) Code Dates / Lot #: 9K02, 9L16, 9L30, 10A12, 10A19, 10B11, 10B12;

3) Code Dates / Lot #: 9J29, 9K02, 9K03, 9K17, 9K19, 9L09, 9L29, 10A13, 10B11, 10B18;
4) Code Dates / Lot #: 10A19, 10B15;

5) Code Dates / Lot #: 9K03, 10B25;

6) Code Date / Lot #: 10B15;

7)  Code Dates / Lot #: 9K09, 9K10, 9L08, 10A14, 10B11
RECALLING FIRM/MANUFACTURER
Modern Products, Inc., Mequon, WI, by press release and letter dated March 25, 2010. FDA initiated recall is ongoing.
REASON
Recall was initiated for spice products that were made with Hydrolyzed Vegetable Protein (HVP) which was recalled by Basic Food Flavors due to potential Salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
111,857 lbs
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
1) Seasoning Salt in 5 pound boxes, Item number 808530. Recall F-2151-2010;

2) Perfect Pepper Seasoning in 5 pound boxes, Item number 808399. Recall # F-2152-2010;

3) Perfect Pepper Dip Mix in 5 pound boxes, Item number 278115. Recall # F-2153-2010;

4) Vegetable Dip Mix in 5 pound boxes, Item number 278112. Recall # F-2154-2010;

5) Southwest Dip Mix in 5 pound boxes, Item number 278109, Recall # F-2155-2010
CODE
1) Manufacturing dates 1/4/2010 and 2/2/2010;
2) Manufacturing date 1/4/2010;
3) Manufacturing date 12/7/2009;
4) Manufacturing dates 1/4/2010 and 2/2/2010;
5) Manufacturing date 2/2/2010
RECALLING FIRM/MANUFACTURER
Dutch Valley Food Distributors, Inc., Myerstown, Pa, by press release on March 9, 2010 and March 16, 2010 and by letter dated March 9, 2010. FDA initiated recall is ongoing.   
REASON
The products were manufactured using spices/pepper recalled by Mincing Overseas Spice Company because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
3,245 lbs
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
Watkins Crab Snack & Dip Seasoning. Made in U.S.A. Packaged as follows: in glass jar, #02054, Net Wt. 4.6 oz (132g) or Single Serving, #71707, Net Wt. 27 g (0.9 oz) which can be part of Sampler Assortment #88020 (4 single servings per assortment). Recall # F-2199-2010
CODE
Lot #39429, 40270, 40261
RECALLING FIRM/MANUFACTURER
Watkins, Inc., Winona, MN, by telephone beginning on March 26, 2010 and by press release on March 31, 2010. FDA initiated recall is ongoing.
REASON
Product was manufactured using Hydrolyzed Vegetable Protein that was recalled by Basic Food Flavors because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
306 – 4 oz units +1,383 individual units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Austinuts Honey Mustard Pretzel, Net Wt 16 oz. Recall # F-2200-2010
CODE
Lot number 61150/0280
RECALLING FIRM/MANUFACTURER
Austinuts Wholesale, Inc., Manor, TX, by press release on March 10, 2010. FDA initiated recall is complete.
REASON
Product was manufactured using Hydrolyzed Vegetable Protein that was recalled by Basic Food Flavors because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
12 bags
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT 
Zatarain's Original Dirty Rice, 8 oz package, Item #Z09535, UPC 7142909535. Recall # F-2141-2010
CODE
BEST BY JAN19 12 H
RECALLING FIRM/MANUFACTURER
McCormick & Co., Inc., Sparks Glencoe, MD, by press release on April 1, 2010. Firm initiated recall is ongoing.
REASON
The product was incorrectly packed into a retail package which does not declare wheat and barley in the ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
11,168 cases
DISTRIBUTION
FL, MI, VA
___________________________________
PRODUCT 
1) Mama Lycha Queso Duroblando 12 oz. cheese. Item #6017. Recall # F-2144-2010;

2) Mama Lycha Queso Duroblando Molido (Bulk) cheese. Item #6019. Recall # F-2145-2010;

3) Mama Lycha Queso Duroblando Molida 18/12 oz. Item #1620. Recall # F-2146-2010
CODE
1) Expiration dates of 5/18 - 6/24/10;
2) Expiration Dates: 7/8 - 8/9/10;
3) Expiration dates 7/12-8/9/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gotera, Inc. DBA Mama Lycha, Houston, TX, by fax on May 4, 2010.
Manufacturer: Lacteos Factory, Miami, FL. FDA initiated recall is ongoing.
REASON
Cheese product may be contaminated with Staph aureus.
VOLUME OF PRODUCT IN COMMERCE
9,764.7 lbs
DISTRIBUTION
TX, AR, IL, GA, FL, MD, OK, LA, NE, KS
___________________________________
PRODUCT 
1) 50% Orange Drink Base 1-10, 50 gal drum, Item #5062OR. Recall # F-2147-2010;

2) 100% Orange Drink Base 1-5, 50 gal drum, Item #5069OR. Recall # F-2148-2010;

3) 100% Juice Blend Drink Base 1-6 Orange 50 gal drum, Item #5072OR. Recall # F-2149-2010;

4) 50% Orange Drink Base 115 gal tote; Item #6063OR. Item #6063OR. Recall # F-2150-2010
CODE
1) Lot #s: 120801, Pack Date, 04/29/08; 198801, Pack Date, 07/16/08; 206801, Pack Date, 07/24/08; 255803, Pack Date, 09/11/08; 262802, Pack Date, 09/18/08; 304801, Pack Date, 10/30/08; 312803, Pack Date, 11/07/08; 350801, Pack Date, 12/15/08; 354801, Pack Date, 12/19/08; 050901, Pack Date, 02/19/09; 078902, Pack Date, 03/19/09; 203901, Pack Date, 07/22/09; 211901, Pack Date, 07/30/09; 223902, Pack Date, 08/11/09; 282901, Pack Date, 10/09/09; 308902, Pack Date, 11/04/09; 365901, Pack Date, 12/31/09; 004001, Pack Date, 01/04/10 & 049001, Pack Date, 02/18/10;

2) Lot #s: 205801, Pack Date, 07/23/08; 238802, Pack Date, 08/25/08; 283802, Pack Date, 10/09/08; 309802, Pack Date, 11/04/08; 352801, Pack Date, 12/17/08; 036901, Pack Date, 02/05/09; 058902, Pack Date, 02/27/09; 208901, Pack Date, 07/27/09; 217902, Pack Date, 08/05/09; 239901, Pack Date, 08/27/09; 273901, Pack Date, 09/30/09; 302901, Pack Date, 10/29/09; 338901, Pack Date, 12/04/09 & 012001, Pack Date, 01/12/10;

3) Lot #s: 137801, Pack Date, 05/16/08; 141801, Pack Date, 05/20/08; 217801, Pack Date, 08/04/08; 220803, Pack Date, 08/07/08; 234801, Pack Date, 08/21/08; 240803, Pack Date, 08/27/08; 276801, Pack Date, 10/02/08; 290801, Pack Date, 10/16/08; 290802, Pack Date, 10/16/08; 303802, Pack Date, 10/29/08; 309801, Pack Date, 11/04/08; 318801, Pack Date, 11/13/08; 330801, Pack Date, 11/25/08; 357801, Pack Date, 12/22/08; 008901, Pack Date, 01/08/09; 022901, Pack Date, 01/22/09; 030901, Pack Date, 01/30/09; 055901, Pack Date, 02/24/09; 057902, Pack Date, 02/26/09; 085903, Pack Date, 03/26/09; 099901, Pack Date, 04/09/09; 118901, Pack Date, 04/28/09; 131901, Pack Date, 05/11/09; 138901, Pack Date, 05/18/09; 138901, Pack Date, 05/18/09; 223901, Pack Date, 08/11/09; 245901, Pack Date, 09/02/09; 266901, Pack Date, 09/23/09; 294901, Pack Date, 10/21/09; 327901, Pack Date, 11/23/09; 337901, Pack Date, 12/03/09; 008001, Pack Date, 01/08/10; 019001, Pack Date, 01/19/10; 055001, Pack Date, 02/24/10; 070001, Pack Date, 03/11/10 & 090001, Pack Date, 03/31/10;

4) Lot #s: 204801, Pack Date, 07/22/08; 210801, Pack Date, 07/28/08; 231801, Pack Date, 08/18/08; 235801, Pack Date, 08/22/08; 246801, Pack Date, 09/02/08; 248801, Pack Date, 09/05/08; 261801, Pack Date, 09/17/08; 266801, Pack Date, 09/22/08; 267801, Pack Date, 09/23/08; 282801, Pack Date, 10/08/08; 282802, Pack Date, 10/08/08; 288801, Pack Date, 10/14/08; 291801, Pack Date, 10/17/08; 303801, Pack Date, 10/29/08; 308801, Pack Date, 11/03/08; 315801, Pack Date, 11/10/08; 322801, Pack Date, 11/17/08; 323801, Pack Date, 11/18/08; 336801, Pack Date, 12/01/08; 340801, Pack Date, 12/05/08; 364801, Pack Date, 12/29/08; 005901, Pack Date, 01/05/09; 012901, Pack Date, 01/12/09; 023901, Pack Date, 01/23/09; 026901, Pack Date, 01/26/09; 033901, Pack Date, 02/02/09; 040901, Pack Date, 02/09/09; 044901, Pack Date, 02/13/09; 048901, Pack Date, 02/17/09; 054901, Pack Date, 02/23/09; 061901, Pack Date, 03/02/09; 071901, Pack Date, 03/12/09; 071902, Pack Date, 03/12/09; 076902, Pack Date, 03/17/09; 082901, Pack Date, 03/23/09; 092901, Pack Date, 04/02/09; 100901, Pack Date, 04/10/09; 111901, Pack Date, 04/21/09; 114901, Pack Date, 04/24/09; 124901, Pack Date, 05/04/09; 126901, Pack Date, 05/06/09; 132901, Pack Date, 05/12/09; 219901, Pack Date, 08/07/09; 232901, Pack Date, 08/20/09; 236901, Pack Date, 08/24/09; 246901, Pack Date, 09/03/09; 257901, Pack Date, 09/14/09; 258901, Pack Date, 09/15/09; 271901, Pack Date, 09/28/09; 278901, Pack Date, 10/05/09; 289901, Pack Date, 10/16/09; 296901, Pack Date, 10/23/09; 310902, Pack Date, 11/06/09; 317901, Pack Date, 11/13/09; 345901, Pack Date, 12/11/09; 355901, Pack Date, 12/21/09; 006002, Pack Date, 01/06/10; 020001, Pack Date, 01/20/10; 021001, Pack Date, 01/21/10; 042001, Pack Date, 02/11/10; 068002, Pack Date, 03/09/10; 071001, Pack Date, 03/12/10; 078001, Pack Date, 03/19/10 & 092001, Pack Date, 04/02/10
RECALLING FIRM/MANUFACTURER
Juice Pac Inc., Bowling Green, KY, by letters on May 7, 2010 and May 11, 2010. FDA initiated recall is ongoing.
REASON
The firm determined it had manufactured four separate drink base products since at least July 2008 that contained an ingredient that contained FD&C Yellow 5. The firm’s labels for the four drink base products manufactured between July 2008 and May 4 2010 did not reflect the presence of FD&C Yellow 5
VOLUME OF PRODUCT IN COMMERCE
2,024/50 gallon drums & 1,046/115 gallon totes
DISTRIBUTION
AL, GA, KY, PA, TN, VA
___________________________________
PRODUCT 
Sea Delight Tuna Steaks. Product of Malaysia, Wild Caught. Packing Date 12/19/09, Best Use By 12/18/11 4oz; Best By 11/25/11. 8oz Net Weight 10 lbs Keep Frozen and Store at 18 C, Thaw Under Refrigeration, Remove From Vacuum Package Before Thawing, Do Not Re-freeze after Defrosted Catch Area: FAO 71. Recall # F-2156-2010
CODE
Lot number: 109
RECALLING FIRM/MANUFACTURER
Sea Delight, LLC, Miami, FL, by letter on April 23, 2010. Firm initiated recall is ongoing.
REASON
Product has elevated histamine levels.
VOLUME OF PRODUCT IN COMMERCE
161 cases (10 lbs per case)
DISTRIBUTION
MI, FL

___________________________________
PRODUCT 
1) Beef Type Flavor, Sales #602935, Lot #5810379874, 50 lb box, Ambient 10-30 C, Mfr. Date 1/22/2010. Recall # F-2157-2010;

2) Garlic Seasoning (WONF), Sales #684562, Lot #5910372036, 100 lb box Ambient 10-30 C, Mfr. Date 1/15/2010. Recall # F-2158-2010
CODE
1) Lot #5810379874;
2) Lot #5910372036
RECALLING FIRM/MANUFACTURER
Givaudan Flavors, Corp., Cincinnati, OH, by letters on March 1, 2010. FDA initiated recall is ongoing.
REASON
Givaudan has been informed that Dry Powder and Paste HVP (Hydrolyzed Vegetable Protein) products manufactured by Basic Food Flavors, Inc. on or after September 17, 2009 are being recalled. A production lot within this time frame has tested positive for Salmonella and Basic Food Flavors and FDA has found Salmonella within the manufacturing facility.
VOLUME OF PRODUCT IN COMMERCE
1,050 lbs
DISTRIBUTION
MO, MS, Canada
___________________________________
PRODUCT 
1) FN30 Beef Flavor, Sales #7946, 50/55 lbs, Box, AMBIENT <35C (95F) , Mfr. Date(s), 12/6/2009, 2/4/2010, 2/16/2010. Recall # F-2159-2010;

2) SN Seafood Flavor Wonf, Sales #7963, 55 lb, Box, AMBIENT <35C (95F), Mfr. Date(s), 12/12/2009, 2/17/2010. Recall # F-2160-2010;

3) Seafood Base 85, Sales #7967, 55 lbs, Box, AMBIENT <35C (95F) , Mfr. Date(s), 12/11/2009. Recall # F-2161-2010;

4) Roast Flavor for Beef, Sales # 8043, 55 lbs, Box, AMBIENT <35C (95F) , Mfr. Date(s), 2/4/2010. Recall # F-2162-2010;

5) Roast Flavor, Sales #8194, 35 lbs, Box, AMBIENT <35C (95F), Mfr. Date(s), 12/10/2009. Recall # F-2163-2010;

6) RFB-LT for Beef Applications, Sales #8723, 55 lbs, Box, AMBIENT 10-30C (50-85F), Mfr. Date(s), 2/3/2010. Recall # F-2164-2010;

7) 33C Chicken Flavored Base, Sales #8767, , 55 lbs, Box, AMBIENT <35C (95F) , Mfr. Date(s), 10/12/2009, 10/12/2009, 11/25/2009, 12/18/2009, 1/6/2010, 1/7/2010, 1/28/2010. Recall # F-2165-2010;

8) Ham Flavour, Sales #8820, 50 lbs, Box, AMBIENT <35C (95F), Mfr. Date(s), 2/13/2010. Recall # F-2166-2010;

9) Chow Mein Type, Sales #8975, 35 lbs, Box, AMBIENT <35C (95F), Mfr. Date(s), 1/6/2010. Recall # F-2167-2010;

10) Cheese Flavor, Sales #10649, 50 lbs, White HDPE Pail, Refrigerate 2-10C (35-50F), Mfr. Date(s), 12/15/2009. Recall # F-2168-2010;

11) Beef Type Flavor, Sales #220901, 50 lbs, Box, AMBIENT 10-30C (50-85F), Mfr. Date(s), 2/13/2010. Recall # F-2169-2010;

12) Sausage Type Flavor, Sales #294924, 50 lbs, Box, Refrigerate 2-10C (35-50F) , Mfr. Date(s), 1/14/2010, 2/4/2010. Recall # F-2170-2010;

13) Sausage Type Flavor, Sales #294925, 50 lbs, Box, Refrigerate 2-10C (35-50F) , Mfr. Date(s), 12/10/2009, 1/7/2010. Recall # F-2171-2010;

14) Sausage Type Flavor, Sales #347261, 100 lbs, Box, Refrigerate 2-10C (35-50F) , Mfr. Date(s), 1/14/2010. Recall # F-2172-2010;

15) Chicken Flavor WONF, Sales #352402, 100 lbs, Box, Refrigerate 2-10C (35-50F) , Mfr. Date(s), 1/7/2010, 2/20/2010. Recall # F-2173-2010;

16) Beef Type Flavor, Sales #356196, 100 lbs, Box, AMBIENT 10-30C (50-85F) , Mfr. Date(s), 1/6/2010. 1/30/2010. Recall # F-2174-2010;

17) Onion Flavor WONF, Sales #364199, 100 lbs, Box, AMBIENT 10-30C (50-85F) , Mfr. Date(s), 1/6/2010. Recall # F-2175-2010;

18) Flavor, Roast Beef Type , Sales #484688, 100 lbs, Box, AMBIENT 10-30C (50-85F) , Mfr. Date(s), 2/1/2010. Recall # F-2176-2010;

19) Chicken Excl Pioneer, Sales #503484, 100 lbs, Box, AMBIENT 10-30C (50-85F) , Mfr. Date(s), 2/5/2010. Recall # F-2177-2010;

20) Sweet Red Onion Type Flavor, Sales #524191, 50 lbs, Box, AMBIENT 10-30C (50-85F) , Mfr. Date(s), 2/27/2010.  Recall # F-2178-2010;

21) Chicken Type Flavor, Sales #532578, 100 lbs, Box, AMBIENT 10-30C (50-85F) , Mfr. Date(s), 11/25/2009. 11/14/2009. Recall # F-2179-2010;

22) Browned Hamburger Type, Sales #557495, 50 lbs, Box, AMBIENT 10-30C (50-85F) , Mfr. Date(s), 1/26/2010. Recall # F-2180-2010;

23) Beef Type Flavor, Sales #570026, 50 lbs, Box, AMBIENT 10-30C (50-85F) , Mfr. Date(s), 1/9/2010. Recall # F-2181-2010;

24) Beef Blend Type Flavor, Sales #583497, 50 lbs, Box, AMBIENT 10-30C (50-85F) , Mfr. Date(s), 1/30/2010. Recall # F-2182-2010;

25) Savory Type Flavor, Sales #601600, Lot #, 6109349950, 50 lbs, Box, Refrigerate 2-10C (35-50F) , Mfr. Date(s), 11/14/2009. Recall # F-2183-2010

26) Savory Flavor, Sales #610024, 50 lbs, Box, AMBIENT <35C (95F) , Mfr. Date(s), 12/5/2009, 12/22/2009, 01/06/2010, 1/26/2010, 1/30/2010. Recall # F-2184-2010;

27) Pork Flavor WONF, Sales #613802, 50 lbs, Box, Refrigerate 2-10C (35-50F) , Mfr. Date(s), 3/3/2010. Recall # F-2185-2010;

28) Optimum Poultry Type, Sales #625351, 50 lbs, Box, COOL 10-18C (50-65F), Mfr. Date(s), 1/14/2010, 2/4/2010. Recall # F-2186-2010;

29) Vegan Burger Spice, Sales #639558, 50 lbs, Box, AMBIENT 10-30C (50-85F) , Mfr. Date(s), 2/20/2010. Recall # F-2187-2010;

30) Chicken Flavor Seasoning, Sales #657297, 50 lbs, Box, AMBIENT 10-30C (50-85F) , Mfr. Date(s), 1/30/2010. Recall # F-2188-2010;

31) Mushroom Flavor WONF, Sales #663613, 50 lbs, Box, AMBIENT 10-30C (50-85F) , Mfr. Date(s), 1/26/2010, 03/3/2010. Recall # F-2189-2010;

32) Modifier T-3 Flavor, Sales #663813, 50 lbs, Fiber drum, AMBIENT 10-30C (50-85F) , Mfr. Date(s), 1/6/2010. Recall # F-2190-2010;

33) Beef Type Flavor, Sales #694201, 50 lbs, Box, AMBIENT 10-30C (50-85F), Mfr. Date(s), 1/6/2010, 1/28/2010. Recall # F-2191-2010;

34) Mushroom Flavor, Sales #3013275, 55 lbs, Box, AMBIENT 10-30C (50-85F) , Mfr. Date(s), 2/20/2010. Recall # F-2192-2010;

35) Chicken Fat Flavor, Sales #3016542, Lot #, 6110375682, 50 lbs, Box, Refrigerate 2-10C (35-50F), Mfr. Date(s), 1/23/2010. Recall # F-2193-2010;

36) Chicken Flavor, Sales #3020236, 50 lbs, Box, AMBIENT 10-30C (50-85F) , Mfr. Date(s), 1/10/2010, 1/11/2010, 11/19/2009, 12/21/2009, 12/21/2009. Recall # F-2194-2010;

37) Italian Flavor WONF, Sales #7I18859, 50 lbs, Box, AMBIENT 10-30C (50-85F) , Mfr. Date(s), 1/27/2010, 12/11/2009, 1/11/2010, 2/15/2010. Recall # F-2195-2010;

38) Roast Beef Type Flavor, Sales #ED-757-626-8, 50 lbs, Box, AMBIENT 10-30C (50-85F) , Mfr. Date(s), 2/13/2010. Recall # F-2196-2010;

39) Lobster Flavor WONF, Sales #MP-966-797-8, Lot # 6109351641, 6109356069, 6109366806, 50 lbs, Box, AMBIENT 10-30C (50-85F), Mfr. Date(s), 11/16/2009, 12/2/2009, 12/15/2009. Recall # F-2197-2010
CODE
1) Lot # 6109358544, 6110379500, 6110388630;
2) Lot # 6109360199, 6110384296;
3) Lot # 6109360202;
4) Lot # 6110379444;
5) Lot # 6109356932;
6) Lot # 6110383756;
7) Lot # 6109342022, 6109342026, 6109359302, 6109368192, 6110372124, 6110373906, 6110381995;
8) Lot # 6110381054;
9) Lot # 6109367363;
10) Lot # 6309357000;
11) Lot # 6110386157;
12) Lot # 6110372608, 6110382018;
13) Lot # 6109357513, 6109365055;
14) Lot # 6109363461;
15) Lot #, 6109368705, 6110392193;
16) Lot # 6109368723, 6110378674;
17) Lot # 6109365607;
18) Lot # 6110383719;
19) Lot # 6110376121;
20) Lot #, 6110387988;
21) Lot #, 6109358645, 6109346182;
22) Lot #, 6109371064;
23) Lot #, 6109366680, 6109356310;
24) Lot # 6110380408;
25) Lot # 6109349950;
26) Lot # 6109360184, 6109366786, 6109371055, 6110375699, 6110383103;
27) Lot # 6110383591;
28) Lot # 6110372505, 6110382014;
29) Lot # 6110392173, 6110392175, 6110392176;
30) Lot # 6110381050;
31) Lot # 6110372078, 6110387073;
32) Lot # 6109371835;
33) Lot # 6109367365, 6110379433;
34) Lot # 6110386843;
35) Lot # 6110375682;
36) Lot # 6110374595, 6110374597, 6109357683, 6109368659, 6109368662;
37) Lot # 6110376074, 6109353315, 6109370328, 6110383585;
38) Lot # 6110384348;
39) Lot # 6109351641, 6109356069, 6109366806
RECALLING FIRM/MANUFACTURER
Recalling Firm: Givaudan Flavors Corp., Cincinnati, OH, by letters on March 1, 2010.
Manufacturer: Givaudan Flavors Corp., Florence, KY. FDA initiated recall is ongoing.
REASON
Givaudan has been informed that Dry Powder and Paste HVP (Hydrolyzed Vegetable Protein) products manufactured by Basic Food Flavors, Inc. on or after September 17, 2009 are being recalled. A production lot within this time frame has tested positive for Salmonella and Basic Food Flavors and FDA has found Salmonella within the manufacturing facility.
VOLUME OF PRODUCT IN COMMERCE
134,459.30 lbs
DISTRIBUTION
AR, CA, CO, FL, GA, IA, ID, IL, KS, MI, NM, OH, PA, SC, TX, WA, WI and Canada

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
___________________________________
PRODUCT 
Glory Foods Seasoned Southern Style Country Cabbage 15 oz double seamed metal cans. Recall # F-2142-2010
CODE
Lot numbers: 6339X1GCCH, 6340W1GCCH, 6340X1GCCH
RECALLING FIRM/MANUFACTURER
Hirzel Canning Co., Northwood, OH, by letters on January 30, 2007. FDA initiated recall is complete.
REASON
Swollen cans of lot 6339X1GCCH were found on many pallets while loading a truck for shipment. Testing by an outside lab found Facultative Bacillus sp. (Terminal spores) in the swollen cans and heat stable spore-forming Bacillus species in a sample of can cooling water that was consistent with the organism found in the can.
VOLUME OF PRODUCT IN COMMERCE
77,520 cans
DISTRIBUTION
AR

___________________________________
PRODUCT 
Turkey/Swiss Cheese Hoagie Sandwiches, fresh made, then frozen, and thawed. Sold as "Ready to Eat” Sandwiches, Item Number: 19233, UPC: 024683192333. Recall # F-2143-2010
CODE
Lot number: 10048, Expiration date: 11/14/2010
RECALLING FIRM/MANUFACTURER
SK Food Group, Reno, NV, by telephone, e-mail, letter on March 30, 2010. Firm initiated recall is ongoing.
REASON
Sandwiches was thought to be contaminated with salmonella. Subsequent testing found that the organism was non-pathogenic e.coli.
VOLUME OF PRODUCT IN COMMERCE
4,080 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
WiseWays Herbals', Dancing Horses Varicose Vein Support, packaged in an amber glass bottle 30 mL (1 oz). The label applied to the bottle is blue. Directions for use: Shake well. Take 10-30 drops 3 x a day in water. Recall # F-2198-2010
CODE
 Lot number: 1420
RECALLING FIRM/MANUFACTURER
Wiseways Herbals LLC, Worthington, MA, by letter on August 27, 2007. Firm initiated recall is complete.
REASON
Product contaminated with soap.
VOLUME OF PRODUCT IN COMMERCE
14/1 oz bottles
DISTRIBUTION
MA, WI

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT 
Semprex-D Capsules (8 mg acrivastine/60 mg pseudoephedrine hydrochloride), 100 Capsule bottles, Rx only; NDC 53014-404-10. Recall # D-549-2010
CODE
Lots A43528, A43529, Exp. 10/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: UCB Manufacturing, Inc., Rochester, NY, by letters dated March 25, 2010.
Manufacturer: DSM Pharmaceuticals Inc., Greenville, NC. Firm initiated recall is ongoing.
REASON
Impurities/Degradation products.
VOLUME OF PRODUCT IN COMMERCE
36762 units (100 count bottles)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Concentrated Tylenol Infants' Drops, (Acetaminophen), 80 mg, a) 1/2 oz Bottle Dropper (UPC 300450122155 and UPC 350580144183), b) 1 oz Bottle Dropper (UPC 300450122018 and UPC Code 300450122100), OTC, Grape Flavor. Recall # D-550-2010;

2) Concentrated Tylenol Infants' Drops (Acetaminophen), 80 mg, 1 oz Bottle Dropper, OTC, Dye Free, Cherry Flavor, UPC 300450167118 and 300450167019. Recall # D-551-2010;

3) Concentrated Tylenol Infants' Drops(Acetaminophen), 80 mg, a)1/2 oz Bottle Dropper (UPC 300450186157); b) 1 oz Bottle Dropper (UPC 300450186300), OTC, Cherry Flavor. Recall # D-552-2010;

4) Concentrated Motrin Infants' Drops (Ibuprofen), 50 mg, a) 1/2 oz Bottle Dropper (UPC 300450198150), b) 1 oz Bottle Dropper (UPC 300450198013 and UPC 300450198112), OTC, Dye-Free, Original Berry Flavor. Recall # D-553-2010;

5) Concentrated Motrin Infants' Drops, (Ibuprofen), 50 mg, 1/2 OZ Bottle Dropper, OTC, Original Berry Flavor, UPC 300450524157. Recall # D-554-2010;

6) Children's Zyrtec Allergy, (Cetirizine HCl) Allergy, 1 mg, Syrup 1/2 oz Bottle, OTC, Bubble Gum, UPC Code 300450205155. Recall # D-555-2010;

7) Johnson's Baby Relief Kit, OTC, which contains Concentrated Tylenol Infants Drops, 1/2 oz Bottle Dropper, Grape and Concentrated Motrin Infants Drops 1/2 oz Bottle Dropper, Berry, UPC Code 381370026426. Recall # D-556-2010
CODE
1) Lot numbers: a) AAM004, AAM021, ABM030, SDM124, SEM051, SFM027, SHM018, SJM130, SLM105, SMM059, SMM072, SMM152, and SSM040, and AAM062, SDM123, SJM131, SMM005, SPM008, SSM003, and SSM034; b) AAM099, SEM099, SFM003, SJM088, SMM009, SMM082, SSM019, SSM080; and  SDM079, SDM080, SDM081, SDM100, SDM101, SEM047, SJM015, SJM089 and SJM162;

2) Lot numbers: SDM097, SDM129, SDM130, SDM131, SEM046, SHM042, SHM061, SJM057, SJM157, and SMM008; and AAM005, AAM085, AAM120, SDM128, SEM098, SFM004, SFM005, SFM006, SHM024, SHM041, SJM087, SJM189, SLM038, SLM039, SLM110, SLM111, SLM112, SMM068, SMM083, SPM038, SPM065, and SSM018;

3) Lot numbers: a) AAM093, SDM093, SEM050, SEM113, SHM032, SJM049, SLM052, SLM104, SMM043, SMM073, SPM009, SPM059, and SSM061; b) SJM137, SLM113, and SPM039;

4) Lot numbers: a) SCM079, SEM072, SJM081, SMM004, SMM166, and SSM072, b) SDM010, SDM011, SDM037, SDM132, SEM048, SEM079, SEM080, SEM101, SEM120, SEM121, SEM122, SEM123, SHM033, SJM056, SJM090, SLM058, SLM059, SLM060, SMM010, SMM011, SMM066, SMM067, SSM048, SSM067; and  SDM098, SDM099, SEM049, SEM100, SFM007, SFM008, SFM009, SHM062, SJM055, and SJM158;

5) Lot numbers: AAM118, AAM119, SDM031, SDM069, SDM092, SEM071, SJM007, SLM053, SMM003, SMM044, SMM167, SSM012, and SSM062;

6) Lot numbers: SMM153, SPC019, SPC022, SPC023, SPM010, and SPM010A;

7) Lot numbers: 2058J, 2748J, 2808J, 2818J, 3088J, 3098J, 3438J, 3458J, 0129J, 0149J, 0709J, 0719J, 0729J, 0759J, 0969J, 0979J, 0989J, 2059J, 2089J, 2109J, 2119J, and 2449J
RECALLING FIRM/MANUFACTURER
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, by letters on March 29, 2010. Firm initiated recall is ongoing.
REASON
Labeling: Incorrect/Missing Lot No.(s): There is a potential for the product lot number and/or expiration date to become illegible on the bottle label.
VOLUME OF PRODUCT IN COMMERCE
18,707,407 bottles, droppers and 66,560 kits
DISTRIBUTION
Nationwide; Dominican Republic , Trinidad & Tobago, Guatemala, Jamaica, Maite, UAE, and Kuwait

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0349-10
CODE
Unit: 024FF07722 (2 units)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by telephone on December 15, 2008 and by letters dated January 15, 2009 and April 20, 2009. Firm initiated recall is complete.
REASON
Blood products, for which quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY
___________________________________
PRODUCT 
Source Plasma. Recall # B-0530-10
CODE
Units: 6120217900, 6120217310, 6120219544
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Columbia, SC, by, letter on March 17, 2009. Firm initiated recall is complete.
REASON
Blood products, for which physical examination was undocumented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland; IL
___________________________________
PRODUCT 
1) Fresh Frozen Plasma. Recall # B-1028-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1030-10
CODE
1) Unit: 012FW39248;
2) Units: 012FW39248, 012FQ86654
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, by letter dated August 31, 2009 and by facsimile on August 31, 2009.  
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.    
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units   
DISTRIBUTION
NC    
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1174-10
CODE
Unit: 09GX52608
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Omaha, NB, by facsimile on September 8, 2009 and letter dated October 19, 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
MD
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1243-10
CODE
Unit: 16LK44602
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by telephone on January 11, 2008 and letter on January 15, 2008. Firm initiated recall is complete.
REASON
Blood product, which was labeled as negative for the Fyb antigen, but was collected from a donor who subsequently tested positive for the Fyb antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1316-10
CODE
Unit: 2818492
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH, by letter dated July 11, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1317-10
CODE
Unit: 6177584
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by fax on September 12, 2008. 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
TX
___________________________________
PRODUCT 
Source Plasma. Recall # B-1318-10
CODE
Units: 381065814, 381065549, 381064763, 381065401, 381065185, 381063964, 381063762, 381063478, 381063186, 381062919, 381062406, 381062067, 381061315, 381061003, 381060233, 381059864, 381059613, 381059147, 381058284, 381058056, 381057760, 381057225, 381056814, 381055669, 381055407, 381054468, 381054275, 381047019, 381046821, 381046387, 381046166, 381043967, 381043739, 381043297, 381043068, 381041480, 381037532 and 381037503
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Peoria, IL, by fax on January 28, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided unreliable information regarding application of tattoos, were distributed.
VOLUME OF PRODUCT IN COMMERCE
38 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1319-10
CODE
Unit: 71X267861
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on July 5, 2005. 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 
Source Plasma. Recall # B-1320-10
CODE
Unit: TA2018966; TA2019245; TA2020000; TA2020261; TA2020593; TA2020742; TA2055913; TA2058976; TA2061324; TA0008168; TA0012574; TA2003530; TA2017954; TA2018305; TA2018497; TA2018840
RECALLING FIRM/MANUFACTURER
Recalling Firm: DCI Biologicals Texarkana LLC, Gallup, NM, by fax, letter and e-mail on July 23, 2008. 
Manufacturer: DCI Biologicals Texarkana, LLC, Texarkana, AR. Firm initiated recall is complete.  
REASON
Blood products, collected from a donor who provided unreliable information regarding application of tattoos and piercings, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
NC, VA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1321-10
CODE
Unit # 1690684
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH, by letters dated July 17, 2007 and September 5, 2007. 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
OH

___________________________________
PRODUCT 
Source Plasma. Recall # B-1322-10
CODE
Units: 2040083641, 2040083417, 2040080677, 2040080432, 2040077653, 2040077393, 2040068825, 2040066383, 2040052816, 2040052582, 2040051758, 2040051398, 2040050802, 2040050247, 2040049341, 2040048657
RECALLING FIRM/MANUFACTURER
Recalling Firm: PlasmaCare, Inc., Cincinnati, OH, by fax on October 12, 2007.
Manufacturer: PlasmaCare Inc., Columbus, OH. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
NC, CA
___________________________________
PRODUCT 
Source Plasma. Recall # B-1324-10
CODE
Units: TA2002497; TA2002724; TA2003225; TA2004361; TA2143790; TA2144131; TA2145043; TA2145477; TA2146044; TA2146285; TA2146888; TA2147459; TA2148579
RECALLING FIRM/MANUFACTURER
DCI Biologicals Texarkana LLC, Texarkana, AR, by fax, letter and e-mail on July 17, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
NC, England
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1328-10; 
2) Plasma Frozen. Recall # B-1329-10
CODE
1) and 2) Unit: W117009320905
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by telephone on January 22, 2010 and by letter dated January 22, 2010. 
Manufacturer: Blood Centers of The Pacific - North Bay Center, Fairfield, CA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1330-10
CODE
Unit: 72M71087X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Inc., Gainesville, GA, by facsimile on January 18, 2010. Firm initiated recall is complete.  
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-1331-10
CODE
Unit: W088409027667
RECALLING FIRM/MANUFACTURER
Blood Bank Of Hawaii, Honolulu, HI, by letter dated January 7, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
HI
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1332-10
CODE
Unit: W227709341682
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by facsimile on January 13, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1334-10
CODE
Unit: 004GZ05862 (Parts 1, 2, & 3)
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by telephone on December 4, 2009 and by facsimile on December 4, 2009 and December 10, 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
3 units
DISTRIBUTION
MA
___________________________________
PRODUCT 
1) Red Blood Cells. Recall # B-1335-10;
2) Plasma Frozen within 24 hours (FP24). Recall # B-1336-10
CODE
1) Units: KL26509, W088609300606, W088609303912;
2) Units: KL26509, W088609303912
RECALLING FIRM/MANUFACTURER
Providence Health System Southern California, Burbank, CA, by letter dated January 13, 2010. Firm initiated recall is complete.  
REASON
Blood products, collected from a donor who was previously deferred for high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Source Plasma. Recall # B-1338-10
CODE
Unit: 0650400015
RECALLING FIRM/MANUFACTURER
CSL Plasma, Racine, WI, by letter July 17, 2008. Firm initiated recall is complete.
REASON
Blood product, for which physical examination was undocumented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1339-10
CODE
Unit: W117009337904
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by letter and telephone on December 14, 2009.
Manufacturer: Blood Centers of the Pacific - North Bay Center, Fairfield, CA, Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1340-10
CODE
Unit: W0352100074914
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and facsimile on February 10, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria, TX
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1342-10
CODE
Units: W117009223294, W117009223294, W11700922552, W117009226998, W117009226998, W117009226998, W117009225527 and W117009225527
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by telephone on January 19, 2010 and letter dated February 12, 2010.  
Manufacturer: Blood Centers of the Pacific - Shasta Blood Center, Redding, CA. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma. Recall # B-1344-10
CODE
Units:  0360038200, 0360034032, 0360032192, 0360031470, 0360030857, 0360030527, 030028617, 0360028249, 0360027393 and 0360027156
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., South Bend, IN, by letter dated July 3, 2007.  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
10 units
DISTRIBUTION
Spain
___________________________________
PRODUCT 
Source Plasma. Recall # B-1345-10
CODE
Units: 7030617976; 7030617474; 7030616311; 7030615662
RECALLING FIRM/MANUFACTURER
ZLB Plasma Services, San Antonio, TX, by e-mail on October 10, 2008 and December 1, 2009. Firm initiated recall is complete.  
REASON
Blood products, collected from a donor who did not receive a required annual physical, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
IN
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1346-10
CODE
Unit: 2441650
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, by letter dated December 28, 2007. 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
KY
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1348-10
CODE
Unit: W118809502610
RECALLING FIRM/MANUFACTURER
The Blood Alliance, Inc., Jacksonville, FL, by letter dated December 15, 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
FL
___________________________________
PRODUCT 
Source Plasma. Recall # B-1349-10
CODE
Unit: 09MMTH7388
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Missoula, MT, by facsimile on January 8, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had not had an annual physical performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Source Plasma. Recall # B-1350-10
CODE
Unit: 09GNDH1815
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Grand Forks, ND, by facsimile on January 4, 2010. Firm initiated recall is complete.   
REASON
Blood product, collected from a donor who had not had an annual physical performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
__________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1351-10
CODE
Unit: W038309031505
RECALLING FIRM/MANUFACTURER
Mississippi Valley Reg. Bld. Center, Davenport, IA, by letter on December 22, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT 
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1352-10;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1353-10
CODE
1) and 2) Unit: W038309062147
RECALLING FIRM/MANUFACTURER
Mississippi Valley Regional Building Center, Davenport, IA, by facsimile on June 29, 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
NY, CA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1354-10
CODE
Units: W051509146805 and W051509146805
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter on January 21, 2006. Firm initiated recall is complete.
REASON
Blood products, which were labeled leukoreduced, but had an unacceptable white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1356-10;
2) Recovered Plasma. Recall # B-1357-10
CODE
1) and 2) Unit: 016KG36090
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by telephone on August 18, 2009 and by electronic notification on August 19, 2009. Firm initiated recall is complete.
REASON
Blood products, which were not quarantined after receiving post donation information concerning an illness following donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH, CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1359-10
CODE
Unit: 16GR56012
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by facsimile and electronic notification on November 5, 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 
Red Blood Cells Leukocytes Reduced. Recall # B-1360-10
CODE
Unit: 026FW26508
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by facsimile on September 26, 2009 and October 30, 2009.
Manufacturer: The American National Red Cross, Mobile, AL. 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
AL   
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1362-10
CODE
Unit: 29KE67178
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic Region, Norfolk, VA, by telephone on November 19, 2009, by electronic notification on November 19, 2009 and November 24, 2009, and by letter dated November 20, 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
VA 
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1364-10
CODE
Unit: W090709018777
RECALLING FIRM/MANUFACTURER
Blood Bank Of The Redwoods, Santa Rosa, CA, by facsimile and electronic notification on August 13, 2009. Firm initiated recall is complete.  
REASON
Blood product, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland and CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1366-10
CODE
Unit: 6312464
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on October 1, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking the medication finasteride, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria, TX

___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1369-10
CODE
Unit: 72K963089 (Parts 2 & 3)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by facsimile on June 23, 2009. Firm initiated recall is complete.  
REASON
Platelets, inappropriately prepared by splitting the product into three storage bags instead of two, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1370-10
CODE
Unit: 72M595604
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by facsimile on January 25, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1371-10
CODE
Unit # 72M465914
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by facsimile on January 25, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1372-10
CODE
Unit: 72M066208
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by facsimile on January 26, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Fenwal PL 2410 Storage Container, 1000 mL with Tubing Leads; a sterile, nonpyrogenic fluid path and container for storage of up to a maximum of 4.7 x 10-11th platelets; 4 containers per pouch, 7 pouches per case; product code 4R2350. Recall # B-1377-10
CODE
Lot number FA10A26035, expiration January, 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fenwal Inc., Lake Zurich, IL, by telephone on March 26, 2010 and letter on March 29, 2010.
Manufacturer: Baxter Fenwal Division, Haina, Dominican Republic. Firm initiated recall is ongoing.
REASON
Amicus Ancillary PL2410 Plastic Storage Containers, associated with reports of leaks on the heat seals at the end of the tubing leads, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3,052 units
DISTRIBUTION
AL, AZ, CA, FL, GA, IL, MI, MN, NJ, NY, OK, PA, TN WA, WI
___________________________________
PRODUCT 
Bone. Recall # B-1378-10
CODE
Units: 094240301, 094240302, 094240303, 094240304, 094240305, 094240306, 094240307, 094240308, 094240314, 094240315, 094240328, 094240329, 094240330, 094240331, 094240332, 094240334, 094240335, 094240336, 094240337, 094240338, 094240339, 094240340, 094240341, 094240342
RECALLING FIRM/MANUFACTURER
Allosource, Centennial, CO, by email and telephone on February 2, 2010. Firm initiated recall is complete.
REASON
Human tissue allografts, with positive pre-processing cultures for group D Enterococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 grafts
DISTRIBUTION
PA, NJ, CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1380-10
CODE
Unit: 72M250257
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on December 2, 2009. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured in accordance to the manufacturer's instructions for leukocyte reduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1399-10
CODE
Unit: 72M554959
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Mobile, AL, by facsimile on January 4, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1400-10
CODE
Unit: 72M581231
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Mobile, AL, by facsimile on January 4, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
1) Platelets Pheresis Leukocytes Reduced. Recall # B-1471-10
2) Red Blood Cells Leukocytes Reduced. Recall # B-1472-10
CODE
1) and 2) Unit: 17FE08229
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by letter on November 7, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN, PA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1473-10;
2) Fresh Frozen Plasma. Recall # B-1474-10
CODE
1) and 2) Units: 55E55829 and 55E56335
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by letter on April 30, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AR, MO

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________
PRODUCT 
1) Influenza A (H1N1) 2009 Monovalent Vaccine, No Preservative 0.50 ml. Recall # B-1024-10;

2) Influenza A (H1N1) 2009 Monovalent Vaccine, No Preservative Pediatric Dose 0.25 ml. Recall # B-1025-10
CODE
1) Unit: UT037AA exp 4/26/2011;

2) Units: UT023AA exp 3/28/2011, UT023BA exp 3/30/2011, UT023CA exp 4/1/2011, UT023EA exp 4/3/2011, and UT023FA exp 4/5/2011
RECALLING FIRM/MANUFACTURER
Sanofi Pasteur, Inc., Swiftwater, PA, by letter dated February 3, 2010. Firm initiated recall is ongoing.
REASON
Influenza A (H1N1) 2009 Monovalent Vaccine, with antigen content lower than the specification limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
960,295 doses
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
Recovered Plasma. Unit: B-1029-10
CODE
Unit: 012FQ86654
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, by letter dated August 31, 2009 and by facsimile on August 31, 2009.  
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.    
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Influenza A (H1N1) 2009 Monovalent Vaccine, Live, Intranasal. The product is shipped in cartons containing 2 trays each tray contains 5 syringes. NDC 66019-200-01. Recall # B-1189-10
CODE
Lot numbers: 500751P, 500754P, 500756P, 500757P, 500758P, 500759P, 500760P, 500761P, 500762P, 500763P, 500764P, 500765P, 500776P
RECALLING FIRM/MANUFACTURER
Recalling Firm: MedImmune, LLC, Gaithersburg, MD, by letters dated December 22, 2009.
Manufacturer: MedImmune, LLC, Philadelphia, PA. Firm initiated recall is ongoing.
REASON
Influenza A (H1N1) 2009 Monovalent Vaccine, with antigen content lower than the specification limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4,818,740 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Cornea. Recall # B-1239-10
CODE
Units: 12770901, 12770902
RECALLING FIRM/MANUFACTURER
Northeast Pa Lions Eye Bank, Inc., Bethlehem, PA, by letter on March 3, 2010. Firm initiated recall is complete.
REASON
Human corneas, recovered from a donor whose donor eligibility was incomplete and subsequently determined to be suitable, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION
CT, PA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1333-10
CODE
Unit: W142809405927, W142809405931, W142809405924, W142809405925, W142809405922, W142809405939
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tri-Counties Blood Bank dba UBS- Central Coast, Santa Barbara, CA, by telephone on December 1, 2009.
Manufacturer: Tri-Counties Blood Bank dba Community Blood Bank, Inc., Rancho Mirage, CA. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly labeled as being collected from volunteer donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1337-10
CODE
Unit: 004E37435
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by telephone and facsimile on October 29, 2009. Firm initiated recall is complete.
REASON
Blood product, manufactured without the additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1341-10
CODE
Unit: W0352100074914
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and facsimile on February 10, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria, TX
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1358-10
CODE
Unit: 16GR56012
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by facsimile and electronic notification on November 5, 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-1361-10
CODE
Unit: 026FW26508
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by facsimile on September 26, 2009 and October 30, 2009.
Manufacturer: The American National Red Cross, Mobile, AL. 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-1363-10
CODE
Unit: 29KE67178
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic Region, Norfolk, VA, by telephone on November 19, 2009, by electronic notification on November 19, 2009 and November 24, 2009, and by letter dated November 20, 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 # Recall # B-1365-10
CODE
Unit: W090709018777
RECALLING FIRM/MANUFACTURER
Blood Bank Of The Redwoods, Santa Rosa, CA, by facsimile and electronic notification on August 13, 2009. Firm initiated recall is complete.  
REASON
Blood product, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland and CA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1367-10
CODE
Unit: 6312464
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on October 1, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking the medication finasteride, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria, TX
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1368-10
CODE
Units: W039709150101M, W039709150103I  
RECALLING FIRM/MANUFACTURER
Heartland Blood Centers, Aurora, IL, by facsimile on August 18, 2009. Firm initiated recall is complete.
REASON
Blood products, collected in expired collections bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS
­­­___________________________________
PRODUCT 
Source Plasma. Recall # B-1376-10
CODE
Units: HS0221865, HS0222190, HS0223067, HS0223952, HS0224548, HS0225666
RECALLING FIRM/MANUFACTURER
DCI Biologicals Hot Springs, Inc., Hot Springs, AR, by facsimile transmission dated December 23, 2009 and by e-mail dated March 8, 2010. Firm initiated recall is complete.
REASON
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
United Kingdom
___________________________________
PRODUCT 
Prevnar. Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM 197 Protein), 0.5 mL single dose pre-filled syringe (10 per package), NDC 0005-1970-50 (10s) and NDC 0005-1970-49 (Singles). NDC 0005-1970-50 - Prevnar Pneumococcal 7-valent Conjugate Vaccine- 1 carton contains 10 single dose (0.5 mL) pre-filled syringes. NDC 0005-1970-49 - Prevnar Pneumococcal 7-valent Conjugate Vaccine- 1 single dose (0.5 mL) pre-filled syringe. Unit size: 10 x 1 (0.5 mL) single dose pre-filled syringes per carton. Shipping Unit Size: 45 cartons of 10 x 1 (0.5 mL) single dose pre-filled syringes per shipper. US License # 3, 103905. Recall # B-1379-10
CODE
Lots: E25197 (EXP 10/13), E28211 (EXP 10/13), E37556 (EXP 10/13), E38749 (EXP 11/13)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals Inc., Philadelphia, PA, by letters dated March 22, 2010.  
Manufacturer: Wyeth Pharmaceuticals, Inc., Pearl River, NY. Firm initiated recall is ongoing.
REASON
Prevnar, with a potential for syringes with a rubber formulation in the tip caps that was not approved for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
46,155 (cartons of 10)
DISTRIBUTION
Nationwide, Puerto Rico and Guam
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1465-10
CODE
Unit: 7165382
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on September 7, 2007. Firm initiated recall is complete.
REASON
A blood product, which did not meet the acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1466-10
CODE
Units: 6060146; 6060167; 6060291; 6060242
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on August 3, and August 4, 2007. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT 
1) Pointe Scientific Iron/TIBC Reagent Set, for the quantitative determination of serum iron and iron binding capacity, Catalog #s: I7504-60, I7504-400, I7504-SAM, 10-I7504-60. Clinical chemistry reagent for the quantitative determination of iron in serum. Recall # Z-0899-2010;

2) Pointe Scientific Total Iron Reagent Set, for the quantitative determination of serum iron, Catalog #s: I7505-120, I7505-500. Clinical chemistry reagent for the quantitative determination of iron in serum. Recall # Z-0900-2010;

3) Pointe Scientific Iron (Ferrozine) Reagent Set, for the quantitative determination of serum iron, Catalog #s: HI704-300, HI904-1200, HI904-498, HI904-600, HI904-SAM-911, HI904-SAM-917 and 12-HI904-144. Clinical chemistry reagent for the quantitative determination of iron in serum. Recall # Z-0901-2010;

4) Pointe Scientific Iron (Ferrozine) R1 Reagent Set, for the quantitative determination of serum iron, Catalog #: HI404-R1. Clinical chemistry reagent for the quantitative determination of iron in serum. Recall # Z-0902-2010;

5) Pointe Scientific Iron (Ferrozine) R2 Reagent Set, for the quantitative determination of serum iron, Catalog #: HI404-R2. Clinical chemistry reagent for the quantitative determination of iron in serum. Recall # Z-0903-2010;

6) Pointe Scientific, Inc. Iron Buffer Reagent. Catalog #s: 7-I7504-BUF-1000, 7-I7504-BUF-120, 7-I7504-BUF-75, 8-I7504-BUF-500 and 3-I7504-BUF. Clinical chemistry reagent for the quantitative determination of iron in serum. Recall # Z-0904-2010;

7) Pointe Scientific, Inc. Iron Color Reagent, Catalog #s: 7-I7504-COL-15, 7-I7504-COL-5, 7-I7504-COL-60, 8-I7504-COL-15, 8-I7504-COL-60 and 3-I7504-COL. Clinical chemistry reagent for the quantitative determination of iron in serum. Recall # Z-0905-2010;

8) Pointe Scientific Iron Reagent (R2), for the quantitative determination of serum iron,  Catalog #: 8HI904-R2-100. Recall # Z-0906-2010
CODE
All lot numbers containing the numbers 735401 or 816501.
RECALLING FIRM/MANUFACTURER
Pointe Scientific, Inc., Canton, MI, by letter dated November 16, 2009. Firm initiated recall is ongoing.
REASON
Turbidity formation could occur, resulting in invalid test results being reported out.
VOLUME OF PRODUCT IN COMMERCE
1082 sets plus 346 L
DISTRIBUTION
Nationwide, Australia, Austria, Bolivia, Canada, Cyprus, Egypt, Ghana, Greece, Guyana, India, Indonesia, Israel, Jordan, Kenya, Korea, Lebanon, Macedonia, Malaysia, Mexico, Nicaragua, Nigeria, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Trinidad, Turkey, Ukraine and Venezuela
___________________________________
PRODUCT 
Aquilion One Whole Body X-Ray CT Scanner Whole body computed tomography scanning. Recall # Z-0907-2010
CODE
Serial Numbers: 1DA0962006, 1DA0972007, 2DA0792002, 2DA0792004, 2DA07X2005, 2DA07X2008, 2DA07Y2010, 2DA0842023, 2DA0842026, 2DA0862034, 2DA0862036, 2DA0872038, 2DA0882048, 2DA0882049, 2DA0882051, 2DA0882052, 2DA0882053, 2DA08X2061, 2DA08X2063, 2DA08X2067, 2DA08X2070, 2DA08X2071, 2DA08X2072, 2DA08Y2077, 2DA08Y2080, 2DA08Z2092, 2DA0952115, 2DA0962116
RECALLING FIRM/MANUFACTURER
Toshiba American Medical Systems Inc., Tustin, CA, by letter on January 7, 2010. Firm initiated recall is ongoing.
REASON
When W-Volume is performed in Prospective CTA or Target CTA studies with ECG gating, unnecessary intervals may be set before starting the volume scan. As a result, scanning cannot be performed at the appropriate timing of constant enhancement and clinically useful images may not be obtained.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Lifesign Staph Latex Kits, 6 ml For In Vitro Diagnostic Use Catalog Number: 50051. A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media. Recall # Z-1110-2010;

2) Wampole Staph Latex Test, 6.0 ml -120 Test Kit For In Vitro Diagnostic Use Catalog Number: 56D6. A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media. Recall # Z-1111-2010
CODE
1) Lot Number: 1009029 Expiration Date: 06-2012;
2) Lot Numbers: 0919119 and 1110049 Exp. Date 06/03/2012
RECALLING FIRM/MANUFACTURER
NERL Diagnostics Corp., East Providence, RI, by letter on January 15, 2010. Firm initiated recall is ongoing.
REASON
Unreactive Staph latex reagent.
VOLUME OF PRODUCT IN COMMERCE
271 units
DISTRIBUTION
NJ
___________________________________
PRODUCT 
Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Recall # Z-1592-2010
CODE
Lot F0620209
RECALLING FIRM/MANUFACTURER
Galt Medical Corp., Garland, TX, by telephone on February 8, 2010 and letter, dated February 10, 2010. Firm initiated recall is ongoing.
REASON
Potential problem with pouch seal thus affecting sterile product.
VOLUME OF PRODUCT IN COMMERCE
400 pcs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920. Intended to be used to centralize the femoral stem within the intramedullary canal. Intended to be used with bone cement. Recall # Z-1601-2010
CODE
Lot code - L3988
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on March 29, 2010. Firm initiated recall is ongoing.
REASON
Stryker became aware that device labels have incorrectly printed manufacture dates and thus incorrect expiration dates on the product label.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO. Recall # Z-1616-2010
CODE
Part numbers only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH, by letters on April 15, 2010.
Manufacturer: Hitachi Medical Systems, Kashiwa City, Japan. Firm initiated recall is ongoing.  
Japan
REASON
Hitachi determined that the mounting method for a Compensation Coil did not include an appropriate factor of safety, so it is possible that the coil could fall, contacting the patient table and potentially putting a patient at risk.
VOLUME OF PRODUCT IN COMMERCE
56 devices
DISTRIBUTION
Nationwide
____________________________________
PRODUCT 
1) Stryker VISUM LED Surgical Lights (Ceiling Mounted Surgical Light), Catalog numbers: 0682001250, 0682001251. Intended to illuminate the operative site during surgical procedures with high intensity light. Recall # Z-1640-2010;

2) Stryker Equipment Delivery System (EDS); Ceiling Mounted Equipment Booms; Catalog Number: 0682000383, 0682000384, 0682000385(A-D), 0682000386(A-D), 0682000426, 0682000429(A-D), 0682000326, 0682000311, 0682000361, 0682000362, 0682000230, 0682000337, 0682000338, 0682000232, 0682000233, 0682000339, 0682000234, 0682000235, 0682000236, 0682000340, 0682000341, 0682000238, 0682000239, 0682000342, 0682000240, 0682000241, 0682000931, 0682000343, 0682000344, 0682000328, 0682000933, 0682000345, 0682000329, 0682000330, 0682000934, 0682000346, 0682000347, 0682000331, 0682000936, 0682000348, 0682000332, 0682000333, 0682000401, 0682000302, & 0682000327. The booms are ceiling mounted devices. They are available in articulating and non-articulating configurations, in single or tandem (pair) configuration, with different shelves configuration to allow for various load capacities. Intended for use as ceiling-mounted devices for supporting or positioning equipment in the surgical suite and/or delivers gases or electricity to these devices. Recall # Z-1641-2010;

3) Stryker VISUM Halogen Surgical Lights (Ceiling Mounted Surgical Lights), Catalog Number: 0682000106; 0682000107. Intended to illuminate the operative site during surgical procedures with high intensity light. Recall # Z-1642-2010;

4) SwitchPoint Element (SPE) Control System. Control System for audio/video, surgical, and room equipment. Catalog Numbers: 067000220, 067000230, 067000231, 067000232, 067000233. Used for direct control of room equipment, audio/video equipment, and indirect control of surgical equipment in the operating room. Recall # Z-1643-2010;

5) SwitchPoint Infinity (SPI) Control System. Catalog Numbers: 067000220, 067000230, 067000231, 067000232, & 067000233. Used for direct control of room equipment, audio/video equipment, and indirect control of surgical equipment in the operating room. Recall # Z-1644-2010;

6) Ceiling Suspensions (Surgical Light and Flat Panel Suspensions); Catalog Numbers: 0682000863, 06820001009, 0682001010, 0682001076, 0682000864, 0682000857, 0682000858, 0682001077, 0682000865, 0682001011, 0682001078, 0682000866, 0682001012, 0682001080, 0682000867, 0682000959, 0682001079, 0682000850, 0682000851, 0682000852, 0682001269, 0682001567, 0682001569, 0682001570, 06820012691, 06820015671, 06820015691, & 0680015701. The ceiling suspensions are available in different configurations; they can hold monitors (flat panel suspensions), cameras (navigation suspensions arms) or surgical lights. The flat panel could have fixed or adjustable monitor yokes and may be single or dual arm configuration. Each ceiling suspension could hold a maximum of two surgical lights and either one camera or one monitor. There may be multiple ceiling/boom suspensions in an operating room. Intended for use as ceiling-mounted devices for supporting or positioning surgical lights, cameras, and/or monitors. Recall # Z-1645-2010
CODE
Product installed Between January 1, 2008 and August 31, 2009.
RECALLING FIRM/MANUFACTURER
Stryker Communications Corp., Flower Mound, TX, by letter, dated April 15, 2010. Firm initiated recall is ongoing.
REASON
Installation records are incomplete.
VOLUME OF PRODUCT IN COMMERCE
270 SwitchPoint Infinity, 9 SwitchPoint Element, and 608 Booms
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
Blackstone Medical Inc.,Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070. Non Sterile. Part number 62-0070. Recall # Z-1653-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blackstone Medical, Inc., Wayne, NJ, letters on March 29, 2010.  
Manufacturer: Kmedic, Kenosha, WI, Firm initiated recall is ongoing.
REASON
The Hallmark Anterior Cervical Plate Bender may have a non conformity causing difficulty accepting 3-4 level plates or to not accept 3-4 level plates that are intended to be additionally contoured.
VOLUME OF PRODUCT IN COMMERCE
112 units
DISTRIBUTION
Nationwide, and Australia
___________________________________
PRODUCT 
Therakos CellEx Photopheresis System; Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument. Recall # Z-1654-2010
CODE
CLXUSA (US): Lot X120, Exp 12/10; X123, Exp 1/2011; Lot Y106, Exp 2/1/11. CLSECP (For European Union), Lot X119, Exp 12/2014; Lot X123; Exp 1/2015
RECALLING FIRM/MANUFACTURER
Therakos, Inc., Raritan, NJ, by letters and telephone on March 29, 2010, March 31, 2010, April 12, 2010 and May 7, 2010. Firm initiated recall is ongoing.  
REASON
Higher than normal blood leaks on THERAKOS CELLEX Procedural Kits that is intended for use with the THERAKOS CELLEX Photopheresis System.
VOLUME OF PRODUCT IN COMMERCE
280 units in US (each unit contains 3 kits)
DISTRIBUTION
Nationwide, Canada and Germany
___________________________________
PRODUCT 
Elekta XiO Radiation Treatment Planning System. Recall # Z-1655-2010
CODE
Release 4.50.00 and above
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letters on April 6, 2010, April 12, 2010 and April 20, 2010. Firm initiated recall is ongoing.
REASON
Under certain circumstances, XiO will over-estimate dose in the region where the backup jaw is inside the MLC opening.
VOLUME OF PRODUCT IN COMMERCE
The release is being used by 34 customers that also have an Elekta linear accelerator
DISTRIBUTION
Nationwide, Canada, Australia, Spain, Italy, the Netherlands, United Kingdom, Taiwan, Malaysia, France, Ireland, and Israel
___________________________________
PRODUCT 
1) GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ, Cardiovascular Imaging System (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Recall # Z-1659-2010;

2) GE Healthcare, Innova 3100 IQ: GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Recall # Z-1660-2010;

3) GE Healthcare, Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Recall # Z-1661-2010
CODE
1) Lot # 0000009C2M0037 0000009C2M0007 00000008C2M001 0000009C2M0032 0000009C2M0154 0000009C2M0065 0000009C2M0072 0000009C2M0078 0000009C2M0084 0000009C2MOO84 0000009C2M0085 0000009C2M0143 0000009C2M0136 0000009C2M0163 0000009C2M0100 0000009C2M0162 0000009C2M0117 0000009C2M0167 0000009C2M0093 0000009C2M0166 0000009C2M0171 0000009C2M0187 0000009C2M0144 0000009C2M0106 0000009C2M0199 0000009C2M0200 0000010C2M0005 0000009C2M0024;

2) Lot # 0000008C2M0006 0000008C2M0003 0000009C2M0029 0000009C2M0014 0000009C2M0028 0000009C2M0057 0000009C2M0049 0000009C2M0013 0000009C2M0040 0000009C2M0025 0000009C2M0023 0000009C2M0041 0000009C2M0021 0000009C2M0046 0000009C2M0033 0000009C2M0058 0000009C2M0053 0000009C2M0056 0000009C2M0060 0000009C2M0150 0000009C2M0062 0000009C2M0009 0000009C2M0030 0000009C2M0064 0000009C2M0054 0000009C2M0042 0000009C2M0068 0000009C2M0059 0000009C2M0010 0000009C2M0016 0000009C2M0074 0000009C2M0096 0000009C2M0088 0000009C2M0090 0000009C2M0104 0000009C2M0077 0000009C2M0063 0000009C2M0148 0000009C2M0101 0000009C2M0067 0000009C2M0157 0000009C2M0156 0000009C2M0175 0000009C2M0111 0000009C2M0120 0000009C2M0128 0000009C2M0127 0000009C2M0131 0000009C2M0130 0000009C2M0147 0000009C2M0097 0000009C2M0110 0000009C2M0118 0000009C2M0192 0000009C2M0119 0000009C2M0160 0000009C2M0177 0000009C2M0205 0000009C2M0209 0000010C2M0011 0000009C2M0071 0000009C2M0178 0000009C2M0185 0000009C2M0082 0000009C2M0081 0000009C2M0126 0000009C2M0122 0000009C2M0180 0000009C2M0197 0000009C2M0109 0000009C2M0112 0000009C2M0115 0000010C2M0002 0000010C2M0006 0000009C2M0139;

3) Lot # 0000009C2M0012 0000008C2M0005 0000009C2M0019 0000009C2M0017 0000009C2M0008 0000009C2M0015 0000009C2M0027 0000008C2M0002 0000009C2M0020 0000009C2M0048 0000009C2M0038 0000009C2M0050 0000009C2M0022 0000009C2M0051 0000009C2M0052 0000009C2M0011 0000009C2M0045 0000009C2M0086 0000009C2M0034 0000009C2M0073 0000009C2M0080 0000009C2M0066 0000009C2M0087 0000009C2M0070 0000009C2M0055 0000009C2M0061 0000009C2M0047 0000009C2M0091 0000009C2M0075 0000009C2M0031 0000009C2M0102 0000009C2M0094 0000009C2M0095 0000009C2M0103 0000009C2M0121 0000009C2M0069 0000009C2M0141 0000009C2M0135 0000009C2M0123 0000009C2M0159 0000009C2M0098 0000009C2M0146 0000009C2M0018 0000009C2M0153 0000009C2M0168 0000009C2M0145 0000009C2M0107 0000009C2M0142 0000009C2M0203 0000009C2M0114 0000009C2M0129 0000009C2M0170 0000009C2M0169 0000009C2M0182 0000009C2M0044 0000009C2M0125 0000009C2M0190 0000009C2M0201 0000009C2M0152 0000009C2M0140 0000009C2M0184 0000010C2M0001 0000009C2M0039 0000009C2M0035 0000009C2M0036 0000009C2M0043 0000009C2M0132 0000009C2M0151 0000009C2M0164 0000009C2M0172 0000009C2M0196 0000009C2M0207 0000009C2M0183 0000009C2M0206 0000009C2M0113 0000009C2M0105 0000009C2M0191 0000009C2M0174 0000009C2M0137 0000009C2M0133 0000009C2M0134 0000009C2M0138 0000009C2M0161 0000009C2M0181 0000009C2M0198 0000010C2M0016 0000009C2M0089 0000009C2M0204 0000009C2M0079 0000009C2M0186 0000009C2M0165 0000009C2M0076
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated March 23, 2010.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.  
REASON
A potential software failure related to the Worklist functionality has been identified on a subset of Innova 2100IQ, 3100IQ and 4100IQ systems. When using the Worklist function to import patient data to Innova, there are two scenarios that will cause the next exam to fail and the inability to recall acquired sequences.
VOLUME OF PRODUCT IN COMMERCE
195 units
DISTRIBUTION
Nationwide, Venezuela, United Kingdom, Turkey, Thailand, Taiwan, Province of China, Sweden, Spain, Russian Federation, Romania, Poland, Philippines, Norway, Netherlands, Morocco, Republic of Korea, Kazakhstan, Japan, Italy, Islamic Republic of Iran, Indonesia, India, Germany, France, Finland, Egypt, China, Chile, Canada, Brazil, Belgium, Belarus, Australia, and Argentina

___________________________________
PRODUCT 
InSound Medical, Inc, Lyric in-canal hearing aid. Recall # Z-1681-2010
CODE
All devices manufactured between 12/10/2009 and 12/24/2009. Expiration dates 12/10/2010 through 12/24/2010.
RECALLING FIRM/MANUFACTURER
InSound Medical, Inc., Newark, CA, by letter on February 1, 2010. Firm initiated recall is ongoing.
REASON
Manufacturing error could result in electrolyte leakage from the product's battery.
VOLUME OF PRODUCT IN COMMERCE
2019 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: a) ASK-01451-BMH; b) ASK-05041-CHC; c) ASK-05041-CHC1; d) ASK-05041-CHM; e) ASK-05041-HMC; f) ASK-05041-QV; g) ASK-07041-BMH; h) CN-05041-LW; i) MSO-01451-UCL; j) MTO-01451-RH; k) PL-05041; l) PR-04041-HPX; m) PR-05041; n) PR-05041-HP; o) PR- 05041-HPX; p) PR-05041-LW; q) PR-05041-MW; r) PR-05041-T; s) PR-05042; t) PR-05541-HPX; u) PR-07041-PTSP; and v) RJ-01451-W. Recall # Recall # Z-1682-2010
CODE
a) Lot numbers RF8060214 and RF8096394; b) Lot numbers RF8109279 and RF9056727; c) Lot numbers RF9069677 and RF9098408; d) Lot numbers RF8057827 and RF8068899; e)  Lot numbers RF8068662, RF8083994, RF8108545, RF9043625, RF9056403, RF9085278, and RF9098580; f)  Lot number RF9097395; g) Lot numbers RF9031839, RF9098784, and RL8108648; h) Lot numbers RF8069608, RF9056127, RF9070920, and RL9019402; i) Lot numbers RF9057410, RF9084460, RL8118758, and RL9029477; j) Lot number RL9019228; k) Lot numbers RF8071766 and RF9109677; l) Lot numbers RF8072920 and RF8109646; m) Lot numbers RF8056742, RF8068423, RF8069651, RF8071677, RF8095208, RF8095832, RF8108465, RF9028902, RF9043449, RF9056132, RF9085152, and RF9086357; n) Lot numbers RF8072840, RF8083506, RF8084926, and RF8107907; o) Lot numbers RF8071099, RF8072981, RF9015967, RF9057607, and RF9097057; p) Lot numbers RF8057252, RF8072743, RF8083529, RF8108466, RF8110585, RF9031472, RF9044054, RF9060502, and RF9097058; q) Lot numbers 8057253, RF8060216, RF8095834, RF8108467, RF8110586, RF9016412, RF9031473, RF9044055, RF9069045, RF9071244, RF9085152, RF9086354, RF9100412, and RF9109679; r) Lot numbers RF8068845 and RF8107962; s) Lot numbers RF8068846, RF8107963, RF8122680, RF9016413, RF9044057, and RF9073297; t) Lot number RF8124014; u) Lot numbers RF8068850, RF8071679, RF8107965, RF8110358, RF9042708, and RF9072922; and v) Lot numbers RF8068664, RF8096774, RF8123596, and RF9060298
RECALLING FIRM/MANUFACTURER
Arrow International Inc., Reading, PA, by letter dated March 29, 2010. Firm initiated recall is ongoing.  
REASON
Tight fit in sheath. Arrow has received complaints of the PICC catheter fitting too tightly in the "kit supplied" peelable sheath. In some cases, clinicians have been unable to insert the catheter through the peelable sheath during the insertion procedure. If the catheter will not pass through the sheath, the clinician is required to place a guide wire back into the sheath, remove the sheath, and place another sheath that the catheter will pass through. This may delay the procedure and/or increase the need for a repeat procedure. Risks associated with delay and/or repeat procedure may include bleeding and infection.
VOLUME OF PRODUCT IN COMMERCE
6,719 units
DISTRIBUTION
Nationwide, Australia, Brazil, Canada, New Zealand, Hong Kong, Malaysia, and Chile
__________________________________
PRODUCT 
1) Juxta-Lite compression wrap Large Short 28cm Length with Anklet Catalog 23025017. Recall # Z-1684-2010;

2) Juxta-Lite compression wrap Medium Short 28cm Length with Anklet Catalog 23024017. Recall # Z-1685-2010;

3) Juxta-Lite compression wrap XL Short 28cm Length with Anklet Catalog 23026017. Recall # Z-1686-2010;

4) Juxta-Lite compression wrap XL Full Calf Short 28cm Length with Anklet Catalog 23026117. Recall # Z-1687-2010;

5) Juxta-Lite compression wrap Large Full Calf Short 28cm Length with Anklet Catalog 23025117. Recall # Z-1688-2010;

6) Juxta-Lite compression wrap XXLShort 28cm Length with Anklet Catalog 23027017. Recall # Z-1689-2010;

7) Juxta-Lite compression wrap XL Long 33cm Length with Anklet Catalog 23036017.
Recall # Z-1690-2010;

8) Juxta-Lite compression wrap XL Full Calf Long 33cm Length with Anklet Catalog 23036117. Recall # Z-1691-2010;

9) Juxta-Lite compression wrap Medium Short 28cm Length with Separate Small AFW Catalog 23124017. Recall # Z-1692-2010;

10) Juxta-Lite compression wrap Large Short 28cm Length with Separate Small AFW Catalog 23125017. Recall # Z-1693-2010;

11) Juxta-Lite compression wrap XLShort 28cm Length with Separate Small AFW Catalog 23126017. Recall # Z-1694-2010;

12) Juxta-Lite compression wrap XL Full Calf Short 28cm Length with Separate Small AFW Catalog 23126117. Recall # Z-1695-2010;

13) Juxta-Lite compression wrap Medium Short 28cm Length with Separate Medium AFW Catalog 23134017. Recall # Z-1696-2010;

14) Juxta-Lite compression wrap Large Short 28cm Length with Separate Medium AFW Catalog 23135017. Recall # Z-1697-2010;

15) Juxta-Lite compression wrap XL Full Calf Short 28cm Length with Separate Medium AFW Catalog 23136117. Recall # Z-1698-2010;

16) Juxta-Lite compression wrap XXL Short 28cm Length with Separate Medium AFW Catalog 23137017. Recall # Z-1699-2010;

17) Juxta-Lite compression wrap XL Full Calf Long 33cm Length with Separate Small AFW Catalog 23226117. Recall # Z-1700-2010;

18) Juxta-Lite compression wrap XL Long 33cm Length with Separate Medium AFW Catalog 23236017. Recall # Z-1701-2010;

19) Juxta-Lite compression wrap XL Full Calf Long 33cm Length with Separate Medium AFW Catalog 23236117. Recall # Z-1702-2010
CODE
All units sold between 2/1/10 and 4/14/10.
RECALLING FIRM/MANUFACTURER
Circaid Medical Products Inc., San Diego, CA, by letter dated April 20, 2010. Firm initiated recall is ongoing.
REASON
Some systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension applied. The system should have 1.25 inches of space. The correct spacing (1.25") is necessary to achieve the measured tension ranges. The incorrect spacing may result in the inability to achieve the correct tension level or discomfort from overtightened bands.
VOLUME OF PRODUCT IN COMMERCE
372 units
DISTRIBUTION
Nationwide, Japan, Canada, Netherlands

___________________________________
PRODUCT 
S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head.
Recall # Z-1703-2010
CODE
Lot # 035D10188
RECALLING FIRM/MANUFACTURER
3m Imtec Corp., Ardmore, OK, by telephone on May 14, 2010 and by letter dated May 14, 2010. Firm initiated recall is ongoing.
REASON
Product has Incorrect size Labeling. Actual length is 13mm. One label is correct, and one states 10mm.
VOLUME OF PRODUCT IN COMMERCE
189 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR JUNE 2, 2010

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