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U.S. Department of Health and Human Services

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Enforcement Report for July 9, 2008

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

July 9, 2008
08-27

 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Homemade Brand Special Recipe Wildberry Parfait Ice Cream in 56-oz. laminated cartons. Product is additionally labeled as "Mixed Berry Swirl in Berry Ice Cream with Whipped Topping", Recall # F-411-8
CODE
Each 56 oz. carton is stamped "32007"
RECALLING FIRM/MANUFACTURER
United Dairy Farmers Inc., Norwood OH, by telephone and e-mail on April 1, 2008. Firm initiated recall is ongoing.
REASON
Product contains undeclared egg white.
VOLUME OF PRODUCT IN COMMERCE
22,332 56 oz laminated cartons
DISTRIBUTION
IL, IN, KY, MI and OH
___________________________________
PRODUCT
Preserved Rose Plum, Foods Farmer’s Grange Series, Net Wt: 128g --- Product of China, UPC 6 920404 307496 --- Nutrition Facts Serving Size I(50g), Servings Per Container 2 --- The product is packaged in a sealed, plastic bag, Recall # F-412-8
CODE
Production Code Q/NFSZ01-2004
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tiffany Food Corp., Brooklyn, NY, by "Consumer Alert" on March 14, 2008 and by letters dated March 17, 2008.
Manufacturer: Guangdong Farmer's Grange Food Industry Co., Ltd., Jieyang City, Guangdong, China. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (308 ppm) and unapproved cyclamates (803 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY, NJ, IL, MA, NC, VA, GA, MI
___________________________________
PRODUCT
Private Selection Light Mint Chocolate Chip Ice Cream in 1.75 quart containers, Recall # F-413-8
CODE
Sell by Dec 03 08 8070; Sell by Dec 03 08 8080
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kroger Co, Cincinnati, OH, by press release and e-mail on April 7, 2008.
Manufacturer: Kroger Texas LP, Fort Worth, TX. Firm initiated recall is ongoing.
REASON
The product may contain undeclared egg and wheat.
VOLUME OF PRODUCT IN COMMERCE
1,444 cases of 4/56 oz laminated cartons
DISTRIBUTION
AL, AR, GA, KS, KY, LA, MS, MO, NE, SC, TN and TX

___________________________________
PRODUCT
Blount Signature Soups New England Clam Chowder, Net wt. 20 oz. cup. Refrigerated Item Number: 72020, UPC: 77958 72020, Recall # F-414-8
CODE
Lot: 0424086D, Use or Freeze By: 06/23/2008
RECALLING FIRM/MANUFACTURER
Blount Fine Foods, Fall River, MA, by telephone and press release on May 6, 2008. Firm initiated recall is complete.
REASON
Product may contain undeclared shrimp.
VOLUME OF PRODUCT IN COMMERCE
59 cases (8 x 20 oz. cups)
DISTRIBUTION
CT, MA
___________________________________
PRODUCT
Silk® Soymilk, chocolate flavor, in 11oz. single serve plastic bottles, UPC 2529360028, packaged in 12 pack clear shrink wrap., Recall # F-415-8
CODE
Use by date of 05 07 08
RECALLING FIRM/MANUFACTURER
Recalling Firm: WhiteWave Foods Co., Broomfield, CO, by press release and letter on April 23, 2008.
Manufacturer: WhiteWave Foods Co., Mount Crawford, VA. Firm initiated recall is complete.
REASON
Product contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
123,852 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT 
Pear concentrate (52 gallons) in a double lined 55 gallon steel drum labeled: Pear Concentrate Brix: 70.0 Net Wt: 585 Lbs Drum # Gross Wt: 625 Lbs, Recall # F-410-8
CODE
Lots: 101507A-M1, 010907-C1, 110107-M5
RECALLING FIRM/MANUFACTURER
Valley Processing, Inc., Sunnyside, WA, by telephone on May 9, 2008 and May 15, 2007, and by letters on May 12 and May 15, 2008. Firm initiated recall is complete.
REASON
Pear concentrate contains levels of inorganic arsenic at greater levels than 23ppb for single strength pear juice.
VOLUME OF PRODUCT IN COMMERCE
lot 010907-C1=97 drums; lot 101507A-M1=100 drums; lot 110107-M5=117 drums
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Kellogg's All-Bran Bran Buds high fiber cereal, made with psyllium, in 17.7 oz. cartons; UPC: 3800001302, Recall # F-416-8
CODE
Lot FEB 23, 2009/KBB026
RECALLING FIRM/MANUFACTURER
Kellogg USA, Inc., Battle Creek, MI, by telephone and letters dated June 23, 2008. Firm initiated recall is ongoing.
REASON
Product may contain non-ferrous metal shavings.
VOLUME OF PRODUCT IN COMMERCE
28,800
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Thanh Thanh Anchovy Dip, 18.5 oz. (524g); UPC #95423 00116, Recall # F-417-8;
b) Saigon Fish Sauce, 20 L; Product of Thailand, Recall # F-418-8
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Thanh Thanh Foods, LLC, Arlington, TX, by telephone and letter beginning on March 6, 2006.
Manufacturer: Heritage Family Specialty Foods, Inc., Grand Prairie, TX. Firm initiated recall is ongoing.
REASON
Product was manufactured using an imported anchovy fish sauce that was not processed under conditions in compliance with Seafood HACCP regulations. Additionally, this anchovy fish sauce may have been manufactured using anchovies 5" or longer, posing a potential for C. botulinum contamination.
VOLUME OF PRODUCT IN COMMERCE
17,636 bottles
DISTRIBUTION
TX, LA and CA
___________________________________
PRODUCT
Foster Farms Dairy Dry Sweetcream Buttermilk, Recall # F-419-8
CODE
“DEC 13 342 LOT 34
RECALLING FIRM/MANUFACTURER
Foster Farms Dairy, Modesto, CA, by telephone on March 27, 2008. Firm initiated recall is ongoing.
REASON
One lot of Dry Sweetcream Buttermilk powder found positive for Salmonella by a private laboratory was distributed.
VOLUME OF PRODUCT IN COMMERCE
4,500 lbs
DISTRIBUTION
IL
___________________________________
PRODUCT
a) Aunt Jemima Buttermilk Complete Pancake & Waffle Mix, packaged in a 2 lb. box, 12 boxes per case,
UPC 30000 05300 and 5 lb. box, 6 boxes per case, UPC 30000 43272, Recall # F-420-8;
b) Aunt Jemima Original Complete Pancake & Waffle Mix; packaged in a 2 lb. box, 12 boxes per case,
UPC 30000 05070, Recall # F-421-8;
c) Aunt Jemima Original Pancake & Waffle Mix; packaged in a 2 lb. box, 12 boxes per case,
UPC 30000 05040, Recall # F-422-8
CODE
a) Best Before Feb 13 09 H, Feb 14 09 H, Feb 15 09 H, Feb 16 09 H; Best Before Feb 08 09 H, Feb 09 09 H;
b) Best Before Feb 13 09 H, Feb 14 09 H, Feb 15 09 H;
c) Best Before Feb 08 09 H
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pepsi-QTG, Chicago, IL, by press release on March 4, 2008.
Manufacturer: The Quaker Oats Co., Danville, IL. Firm initiated recall is ongoing.
REASON
The pancake mix may have potential salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
1, 526 cases – 2 lb. boxes and 448 cases – 5 lb. boxes
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
Methadone HCI Oral Solution, 20mg, Recall # D-232-2008
CODE
VistaPharm Lot # 135100 Whitney Lot # 5364 L
RECALLING FIRM/MANUFACTURER
Whitney Labs, Ormond Beach, FL, by telephone on March 14, 2008. Firm initiated recall is ongoing.
REASON
Misbranded; bottles labeled as containing 20mg Methadone HCI actually contains 260 mg Methadone HCI.
VOLUME OF PRODUCT IN COMMERCE
143 bottles
DISTRIBUTION
AL, NC, NH, FL

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Guanfacine Tablets, USP 1 mg, 100 and 500 count bottles, NDC 52152-118-04 , NDC 52152-118-02; 100 count bottles, NDC 0603-3774-21; 100 count bottles, NDC 0904-5579-60,
Recall # D-234-2008
CODE
Lots: 60366A1 Apr-08 60583A1 Jun-08 60583A2 Jun-08 60746A1 Aug-08 60746A2 Aug-08 60955A1 Nov-08 60955A2 Nov-08 70012A1 Jan-09 70012A2 Jan-09 70230A1 Mar-09 70230A2 Mar-09 70329A1 Apr-09 70499A1 Jun-09 70634A1 Jul-09 70634A2 Jul-09 70943A1 Nov-09 70943A2 Nov-09 80042A1 Jan-10 80106A1 Feb-10
RECALLING FIRM/MANUFACTURER
Actavis Totowa LLC, Totowa, NJ, by letters on April 30, 2008. Firm initiated recall is ongoing.
REASON
Exceeded impurity specification.
VOLUME OF PRODUCT IN COMMERCE
18 lots
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Guanfacine Tablets, USP 2 mg, 100 and 500 count bottles, Rx only, NDC 52152-119-04 - 500 tablets; NDC 52152-119-02 - 100 tablets, Recall # D-235-2008
CODE
Lots: 60317A1 Apr-08 60317A2 Apr-08 60509A1 Jun-08 60509A2 Jun-08 60956A1 Nov-08 60956A2 Nov-08 70011A1 Jan-09 70011A2 Jan-09 70491A1 Jun-09 70491A2 Jun-09 70635A1 Jul-09 70635A2 Jul-09 70944A1 Nov-09 70944A2 Nov-09 80101A2 Feb-10 80101A1 Feb 10
RECALLING FIRM/MANUFACTURER
Actavis Totowa LLC, Totowa, NJ, by letters on April 30, 2008. Firm initiated recall is ongoing.
REASON
Exceeded impurity specification.
VOLUME OF PRODUCT IN COMMERCE
16 lots
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, 0.5mg/3mg, Sterile Unit Dose Vials, For Inalation Only, packaged as 6 pouches of 5 (3 ml) vials each (30 unit-dose vials) NDC 0093-6723-73 and 12 pouches of 5 (3 ml) vials (60 unit-dose vials) NDC number 0093-6723-74, Recall # D-236-2008
CODE
Lot number W21181 exp 9/2009 and Lot number W21501 exp 10/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, North Wales, PA, by letter on May 21, 2008.
Manufacturer: IVAX Pharmaceuticals U.K., Ltd. Cheshire, UK. Firm initiated recall is ongoing.
REASON
Failed pH Specification
VOLUME OF PRODUCT IN COMMERCE
2,123,450 vials
DISTRIBUTION
LA, NC, NJ, NV, OH, and PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Human allografts consisting of aortic and pulmonary valves, and pulmonary patch grafts, Recall # B-1016-08
CODE
042443HV01; 042443HV02
RECALLING FIRM/MANUFACTURER
Lifenet, Virginia Beach, VA, by letters on October 16, 2007 and November 5, 2007. Firm initiated recall is complete.
REASON
Human tissues from donors, tested using diagnostic test kits rather than FDA licensed or cleared screening tests for hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc total), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
HyperRHO" S/D Mini-Dose, Rho(D) Immune Globulin (Human), Solvent/Detergent Treated, 10 single dose disposable syringes with attached needles, NDC 13533-631-06, Recall # B-1423-08
CODE
Lot 26N7XX1, Expiration Date 29 JUN2009
RECALLING FIRM/MANUFACTURER
Talecris Biotherapeutics, Inc., Clayton, NC, by letter on/about April 18, 2008. Firm initiated recall is ongoing.
REASON
One lot of HyperRHO S/D, Mini Dose currently tested less than the full potency of 250 IU/dose, was distributed.
VOLUME OF PRODUCT IN COMMERCE
21070 vials
DISTRIBUTION
CA, CT, FL, IA, IN, MO, NC, NJ, NY, NV, SC, TN, TX, VA, WA, WY `
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1537-08;
b) Recovered Plasma, Recall # B-1538-08
CODE
a) and b) N07255
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by electronic notification on August 14, 2007 and by letter dated September 21, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeld-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA and Switzerland
___________________________________
PRODUCT
a) Platelets, Recall # B-1539-08;
b) Fresh Frozen Plasma, Recall # B-1540-08
CODE
a) and b) N28174
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by letter dated July 20, 2007. Firm initiated recall is complete.
REASON
Blood products collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1564-08
CODE
150189277 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock Center, Lubbock, TX, by letters dated September 22, 2006, November 13, 2006 and June 7, 2007. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1565-08
CODE
150178334
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock Center, Lubbock, TX, by letter dated September 28, 2006. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1566-08
CODE
158324601
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock Center, Lubbock, TX, by letter dated January 26, 2007. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Human allografts consisting of aortic and pulmonary valves, and pulmonary patch grafts, Recall # B-1015-08
CODE
03-4665HV-01 03-4665HV-02 03-4665HV-03 03-4665HV-04 04-0124HV-01 04-0124HV-02 04-0213HV-01 04-0213HV-02 04-0352HV-02 04-0352HV-03 04-0434HV-02 04-0434HV-03 04-0469HV-02 04-1066HV-01 04-1183HV-01 04-1183HV-02 04-1195HV-01 04-1195HV-02 04-1202HV-01 04-1202HV-02 04-1202HV-03 04-1202HV-04 04-1295HV-02 04-1295HV-03 04-1295HV-04 04-1485HV-02 04-1525HV-01 04-1856HV-02 04-2065HV-02 04-2158HV-01 04-2158HV-02 04-2295HV-01 04-2295HV-02 04-2895HV-02 04-2935HV-01 04-2935HV-02 04-2935HV-03 04-3027HV-02 04-3395HV-02 04-3593HV-01 04-3593HV-02 04-3593HV-03 04-3752HV-02 04-3752HV-03 04-3853HV-02 04-4249HV-01 04-4249HV-02 04-4941HV-02 04-4941HV-03 04-5187HV-02 04-5377HV-02 05-0035HV-02 05-0097HV-02 05-0227HV-02 05-0458HV-02 05-0641HV-02 05-0856HV-02 05-0856HV-03 05-1072HV-01 05-1072HV-02 05-1551HV-02 05-1923HV-02 05-2227HV-01 05-2741HV-01 05-2741HV-02 05-2741HV-03 05-2820HV-01 05-2820HV-02 05-2820HV-03 05-2884HV-01 05-2884HV-02 05-2884HV-03 05-2958HV-02 05-2958HV-03 05-3189HV-01 05-3189HV-02 05-3420HV-02 05-3420HV-03 05-3420HV-04 05-3420HV-05 05-3614HV-02 05-4045HV-02 05-4045HV-03 05-4233HV-01 05-4233HV-02 05-4447HV-02 05-4447HV-03 05-5176HV-02 05-5531HV-02 06-0490HV-01 06-0490HV-02 06-0987HV-02 06-1084HV-01 06-1084HV-02 06-1084HV-03 06-1084HV-04 06-1582HV-02 06-1655HV-02 06-2452HV-02 06-2507HV-02 06-2962HV-02 06-2962HV-03 06-3052HV-02 06-3235HV-02 06-3519HV-01 06-3630HV-02 06-3630HV-03 06-3696HV-01 06-3696HV-02 06-3887HV-02 06-6175HV-02 06-6175HV-03 06-6175HV-04 06-6227HV-02 06-6367HV-02 07-1644HV-02 07-1644HV-03 07-1679HV-01 07-1679HV-02 07-1679HV-03 07-2189HV-02 07-3286HV-02 07-3475HV-02
RECALLING FIRM/MANUFACTURER
Lifenet, Virginia Beach, VA, by letters on October 16, 2007 and November 5, 2007. Firm initiated recall is complete.
REASON
Human tissues from donors, tested using diagnostic test kits rather than FDA licensed or cleared screening tests for hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc total), were distributed.
VOLUME OF PRODUCT IN COMMERCE
123 tissues
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Red Blood Cells Irradiated, Recall # B-1563-08
CODE
Unit: 1001844
RECALLING FIRM/MANUFACTURER
The Queen’s Medical Center, Honolulu, HI, by telephone on October 25, 2005 and by facsimile on October 27, 2005. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
HI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1567-08
CODE
Unit: 003KM39601
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA, by telephone on August 17, 2007 and by letter dated August 24, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a discordant result for body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
1) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX060603CD; Recall # Z-1246-2008;
2) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX060403CD; Recall # Z-1247-2008;
3) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX060803CD; Recall # Z-1248-2008;
4) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX070403CD; Recall # Z-1249-2008;
5) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX070603CD; Recall # Z-1250-2008;
6) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX080403CD; Recall # Z-1251-2008;
7) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX080401CD; Recall # Z-1252-2008;
8) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX080803CD; Recall # Z-1253-2008;
9) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX080601CD; Recall # Z-1254-2008;
10) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX100401CD; Recall # Z-1255-2008;
11) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX090603CD; Recall # Z-1256-2008;
12) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX070803CD; Recall # Z-1257-2008;
13) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX100601CD; Recall # Z-1258-2008;
14) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX060303CD; Recall # Z-1259-2008;
15) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX090401CD; Recall # Z-1260-2008;
16) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX 070303CD; Recall # Z-1261-2008;
17) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX060401CD; Recall # Z-1262-2008;
18) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX090601CD; Recall # Z-1263-2008;
19) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX100403CD; Recall # Z-1264-2008;
20) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX060601CD; Recall # Z-1265-2008;
21) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX080303CD; Recall # Z-1266-2008;
22) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX070401CD; Recall # Z-1267-2008;
23) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX060801CD; Recall # Z-1268-2008;
24) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX070203CD; Recall # Z-1269-2008;
25) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX100603CD; Recall # Z-1270-2008;
26) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX070601CD; Recall # Z-1271-2008;
27) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX100801CD; Recall # Z-1272-2008;
28) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX080301CD; Recall # Z-1273-2008;
29) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX090403CD; Recall # Z-1274-2008;
30) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX080801CD; Recall # Z-1275-2008;
31) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX060203CD; Recall # Z-1276-2008;
32) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX070801CD; Recall # Z-1277-2008;
33) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX080203CD; Recall # Z-1278-2008;
34) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX100303CD; Recall # Z-1279-2008;
35) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX090301CD; Recall # Z-1280-2008;
36) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX070301CD; Recall # Z-1281-2008;
37) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX100301CD; Recall # Z-1282-2008;
38) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX100903CD; Recall # Z-1283-2008;
39) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX060301CD; Recall # Z-1284-2008;
40) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX100803CD; Recall # Z-1285-2008;
41) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX090803CD; Recall # Z-1286-2008;
42) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX090303CD; Recall # Z-1287-2008;
43) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX100201CD; Recall # Z-1288-2008;
44) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX090801CD; Recall # Z-1289-2008;
45) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX090201CD; Recall # Z-1290-2008;
46) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX060201CD; Recall # Z-1291-2008;
47) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX100203CD; Recall # Z-1292-2008;
48) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX090203CD; Recall # Z-1293-2008;
49) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX070201CD; Recall # Z-1294-2008;
50) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX100901CD; Recall # Z-1295-2008;
51) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;
Model Number: EX080603CD; Recall # Z-1296-2008
CODE
1) Lot Numbers: FR6F0111 (Exp 2008/06), FR6G0120 (Exp 2008/08), FR6G0121 (Exp 2008/08),
FR6H0135 (Exp 2008/08), FR6H0182 (Exp 2008/08) and FR6H0192 (Exp 2008/08);
2) Lot Numbers: FR6G0118 (2008/07), FR6G0119 (2008/08), FR6H0137 (Exp 2008/08),
FR6H0194 (Exp 2008/08) and FR6H0203 (Exp 2008/08);
3) Lot Numbers: FR6G0122, (Exp 2008/07), FR6G0123 (Exp 2008/08), FR6H0193 (Exp 2008/08)
and FR6H0201 (Exp 2008/08);
4) Lot Numbers: FR6G0124 (Exp 2008/08), FR6G0125 (Exp 2008/07) and FR6H0181 (Exp 2008/08);
5) Lot Numbers: FR6G0126 (Exp 2008/07), FR6G0127 (Exp 2008/08) and FR6H0200 (Exp 2008/08);
6) Lot Number: FR6G0129;
7) Lot Number: FR6G0131;
8) Lot Number: FR6G0132;
9) Lot Number: FR6GG0133;
10) Lot Numbers: FR6G0134 (Exp 2008/08), FR6H0179 (Exp 2008/08) and FR6H0197 (Exp 2008/08);
11) Lot Number: FR6H0173 (Exp 2008/08);
12) Lot Numbers: FR6H0139 (Exp 2008/08) and FR6H0199 (Exp 2008/08);
13) Lot Number: FR6H0140;
14) Lot Number: FR6H0141;
15) Lot Number: FR6H0142;
16) Lot Number: FR6H0150 ;
17) Lot Number: FR6H0151;
18) Lot Number: FR6H0152;
19) Lot Number: FR6H0153;
20) Lot Number: FR6H0154;
21) Lot Number: FR6H0155;
22) Lot Number: FR6H0156;
23) Lot Number: FR6H0157;
24) Lot Number: FR6H0158;
25) Lot Number: FR6H0159;
26) Lot Number: FR6H0160;
27) Lot Number: FR6H0161;
28) Lot Number: FR6H0162;
29) Lot Number: FR6H0163;
30) Lot Number: FR6H0164;
31) Lot Number: FR6H0165;
32) Lot Number: FR6H0166;
33) Lot Number: FR6H0167;
34) Lot Number: FR6H0168;
35) Lot Number: FR6H0169;
36) Lot Number: FR6H0170;
37) Lot Number: FR6H0172;
38) Lot Number: FR6H0174;
39) Lot Number: FR6H0175;
40) Lot Number: FR6H0176;
41) Lot Number: FR6H0178;
42) Lot Number: FR6H0184;
43) Lot Number: FR6H0185;
44) Lot Number: FR6H0186;
45) Lot Number: FR6H0187;
46) Lot Number: FR6H0188;
47) Lot Number: FR6H0189;
48) Lot Number: FR6H0190;
49) Lot Number: FR6H0191;
50) Lot Numbers: FR6H0198;
51) Lot Number: FR6H0204, RFR6H0206
RECALLING FIRM/MANUFACTURER
Edwards Lifesciences LLC, Irvine, CA, by letter on December 5, 2007. Firm initiated recall is ongoing.
REASON
Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised.
VOLUME OF PRODUCT IN COMMERCE
401 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Voxar 3D software; and Impax 5.0 and Impax 5.2 PACs with integrated MediCAD software. The softwares are used to provide digital X-ray images for pre-surgical orthopedic planning, Z-1307-2008
CODE
Hectec MediCAD: ETSAN; VOXAR 3D: L72JO; and Impax 4.5 or 5.0 or 5.2 Client /OT3000: A component of Order Codes: 60+00021533, 60+00021534, 60+00022471, 60+00022472, 60+00015451, 60+00015453, 60+00021535 and 60+00024519
RECALLING FIRM/MANUFACTURER
AGFA Corp., Greenville, SC, by letters on February 17, 2007. Firm initiated recall is ongoing.
REASON
Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient.
VOLUME OF PRODUCT IN COMMERCE
879 units
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; Recall # Z-1314-2008
CODE
Lot Numbers: 7G29699, 7G30740, 7G31418, 7H22693, 7H24608, 7J30626, 7J32192 and 7K30871. Lot numbers 7L27391, 8A33519 and 8A37099 are also affected, however they have not been distributed.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ConvaTec, Skillman, NJ, by letter on March 7, 2008.
Manufacturer: Convatec, A Bristol-Myers Squibb Co., Greensboro, NC. Firm initiated recall is ongoing.
REASON
Mislabeled: The carton label reads "For post-surgical use following a urostomy procedure." It should read "For post-surgical use following a colostomy or ileostomy procedure."
VOLUME OF PRODUCT IN COMMERCE
9,299 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
___________________________________
PRODUCT
Neo-Sulfalyte, neomycin/sulfamethazine/electrolyte bolus, each bolus contains 250-mg. neomycin, 2,000-mg. sulfamethazine, 38-mg. potassium acetate, 11-mg. magnesium chloride hexahydrate, 11-mg. calcium chloride dihydrate, 209-mg. sodium chloride, and 229-mg. sodium acetate trihydrate, packaged in 50-bolus bottles, 12 per case, Recall # V-211-2008
CODE
Lot # 2724786, Exp. 8/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc. Of Canada, Kirkland, Canada, by telephone on May 30, 2008 and by letters dated June 5, 2008.
Manufacturer: Pfizer Global Mfg, Lincoln, NB. Firm initiated recall is ongoing.
REASON
OOS for neomycin potency (low)
VOLUME OF PRODUCT IN COMMERCE
1,441/50-bolus bottles
DISTRIBUTION
Canada
 

END OF ENFORCEMENT REPORT FOR JULY 9, 2008

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