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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.
June 11, 2008
08-24
___________________________________
PRODUCT
Turnip Pickles in 10 oz, 20 oz, and 20 pound containers but all labeled as: Turnip Pickle, New wt. 20 oz; UPC 7739735560, Recall # F-392-8
CODE
All containers; no lot numbers are used.
RECALLING FIRM/MANUFACTURER
Jerusalem Foods, Inc., Dearborn, MI, by letter dated April 10, 2008. Firm initiated recall is ongoing.
REASON
Product contains a banned color additive; Red # 19.
VOLUME OF PRODUCT IN COMMERCE
Approx. 937 containers
DISTRIBUTION
IN, KY, MI, NC, OH and PA
___________________________________
PRODUCT
Maggie and Mary's Chicken Dumpling Soup, Flavored with Chicken, Net Wt 5 oz (148g). Ingredients: Dumplings....Dehydrated Chicken...and Turmeric (added to color), Recall # F-395-8
CODE
Retail Box lot Codes: 0730810, 0720810, 0910810,0920811,0920810, 0930810, 0980810 Individual dumpling pouch batch code: 23-04-2009
RECALLING FIRM/MANUFACTURER
North Aire Market, Inc., Shakopee, MN, by press release and by telephone or e-mail on April 8, 2008. Firm initiated recall is ongoing.
REASON
The dumplings in the soup mix may have been exposed to residual traces of almonds which may have been present on machinery used to package a blend containing product earlier. Although no almond traces were found on the machinery, no almond traces were found within any dumpling packages, and there were no reports of illness associated with this, we could not be certain that no exposure occurred and because of this decided it was best to recall the 99 boxes that were determined could have been part of this possible exposure
VOLUME OF PRODUCT IN COMMERCE
99 boxes
DISTRIBUTION
Nationwide
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PRODUCT
Kraft Roasted Red Pepper Italian with Parmesan Dressing and Marinade; the dressing was previously labeled as Kraft Roasted Red Pepper Italian with Parmesan Dressing; the dressing is packed in 16 fl. oz. plastic bottles, 6 bottles per case; UPC 0 21000 70144 5, Recall # F-391-8
CODE
Best When Used By 27 AUG 2008 C was recalled initially. The recall was expanded on 4/3/08 to include the following additional lots: 19 APR 2008 C, 20 APR 2008 C, 07 MAY 2008 C, 08 MAY 2008 C, 16 MAY 2008 C, 03 JUN 2008 C, 04 JUN 2008 C, 02 AUG 2008 C, 03 AUG 2008 C, 06 SEP 2008 C and 07 SEP 2008 C
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kraft Foods, Inc., Northfield, IL, by letter on March 27, 2008 and April 3, 2008. Firm initiated recall is complete.
REASON
Some of the bottles of dressing are spoiling before the best-when-used-by date.
VOLUME OF PRODUCT IN COMMERCE
174,051 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Fresh vacuum packed marlin loins imported by Alfa International Seafood, Inc. , packed in 109 lbs. bulk cartons. This carton contains 9/12 lbs. vacuum packed loins. The carton is labeled in part: PERISHABLE FRESH FISH, NET WT 109 PIECE 9, Recall # F-393-8
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alfa International Seafood, Inc., Miami, FL, by telephone on August 30, 2007.
Manufacturer: FRIGOLAB SAN MATEO PRODUCTO OF MANTA-ECUADOR. Firm initiated recall is ongoing.
REASON
The individual vacuum packed units of product had time-temperature indicators (TTIs), which center was darker than the reference color. This indicated that, the end point has been exceeded, and the product should not be used.
VOLUME OF PRODUCT IN COMMERCE
1,729 lbs.
DISTRIBUTION
FL
___________________________________
PRODUCT
a) Thyro-Tab 0.025mg, 150,000-tablet bulk drums intended for repackaging, Rx only,
Recall # D-220-2008;
b) Levothroid (levothyroxine sodium tablets, USP), 25 mcg, 100- and 1,000-tablet
bottles, RX only; NDC 0456-1320-01 (100-ct.) and NDC 0456-1320-00 (1,000-ct.),
Recall # D-221-2008
CODE
a) Lot HA08207, Exp. April 2008; Lot HC13007, Exp. May 2008;
b) Lot 050701 (100-tab.) and 050702 (1,000-tab), both from bulk lot HA08207, Exp.
April 2008; Lot 060736 (100-tab.) and 070706 (1,000-tab), both from bulk lot
HC13007, Exp. May 2008
RECALLING FIRM/MANUFACTURER
Lloyd Inc of Iowa, Shenandoah, IA, by letters dated April 14. 2007 and April 23, 2008. Firm initiated recall is ongoing.
REASON
Subpotent; (8-month and 9-month stability intervals)
VOLUME OF PRODUCT IN COMMERCE
3,820,252 bulk Thyro-Tab tablets; 17,681/100-tab. bottles and 632/1,000-tab. bottles Levothroid
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Paroxetine Tablets, USP, 20 mg, 100 count bottles, NDC Number: 68382-098-01, Recall # D-222-2008
CODE
Lot MG3179, Exp date 5/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zydus Pharmaceuticals USA Inc., Princeton, NJ, by letters on April 22, 2008.
Manufacturer: Cadila Healthcare Ltd., Ahmedabad, India. Firm initiated recall is ongoing.
REASON
Mislabeled; bottle labeled as containing Paroxetine 20 mg Tablets actually contain Warfarin 4mg Tablets
VOLUME OF PRODUCT IN COMMERCE
14,256 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Multiret Folic 500 Tablets, ferrous sulfate, 525 mg, 6 x 10 film coated tablets, Rx only, --- Also labeled as Multiret Folic 500 Tablets, Amide Pharmaceutical ---- NDC 52152-048-14 and Multi-Ferrous Folic 500 Tablets, NDC 0677-0990-06, Recall # D-223-2008
CODE
NDC 0677-0990-06; Lot 06358A1; Exp. date: Apr.08;
NDC 52152-048-14: Lot numbers: 60358A2, Exp. date: Apr. 08; Lot 60358A3, Exp. date Apr 08; Lot 60358A4, Exp. Apr 08; Lot 60633A1, Exp. Jul 08; Lot 60633A2, Exp. Jul 08; Lot 60823A1, Exp. Sep 08; Lot 60823A2, Exp. Jul 08; Lot 60823A3, Exp. Spe 08; Lot 70065A1, Exp. Jan 09; Lot 70065A2, Exp. Jan 09;
Lot Numbers 70254A1, Exp Mar 09; Lot 70254A2, Exp. Mar 09; Lot 70607A1, Exp Jul. 09; Lot 70819A1, Exp Nov. 09 60358A1 Apr-08 60358A2 Apr-08 60358A3 Apr-08 60358A4 Apr-08 60633A1 Jul-08 60633A2 Jul-08 60823A1 Sep-08 60823A2 Sep-08 60823A3 Sep-08 70065A1 Jan-09 70065A2 Jan-09 70254A1 Mar-09 70254A2 Mar-09 70607A1 Jul-09 70819A1 Nov-09
RECALLING FIRM/MANUFACTURER
Actavis Totowa LLC, Totowa, NJ, by letters on April 30, 2008. Firm initiated recall is ongoing.
REASON
Subpotent; Folic Acid
VOLUME OF PRODUCT IN COMMERCE
15 lots; 169,433 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
PREMPRO® (conjugated estrogens/medroxyprogesterone acetate tablets) 0.3 mg/1.5 mg, Rx only, one carton contains 3 EZ-DIAL® Dispensers of 28 tablets each. One EZ-DIAL® Dispenser (NDC 0046-0938-08) contains 28 cream PREMPRO® Tablets containing 0.3 mg of the conjugated estrogens found in PREMARIN® & 1.5 mg of medroxyprogesterone acetate; NDC 0046-0938-09, Recall # D-218-2008
CODE
Lot: B88216, Exp. 09/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Philadelphia, PA, by letters dated April 2, 2008.
Manufacturer: Wyeth Pharmaceuticals, Inc., Rouses Point, NY. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Specifications
VOLUME OF PRODUCT IN COMMERCE
23,832 cartons of 3 Dispensers
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100 tablet bottles, NDC 67253-263-10 and 1000 tablet bottles, NDC 67253-263-11, Rx only, Recall # D-233-2008
CODE
Lot Number 61895A (100's); Lot Number 61895B (1000's)
RECALLING FIRM/MANUFACTURER
Recalling Firm: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, by letters on May 2, 2008.
Manufacturer: West-Ward Pharmaceutical Corp., Eatontown, NJ. Firm initiated recall is ongoing.
REASON
Exceeded Impurity Specification; 24 month stability.
VOLUME OF PRODUCT IN COMMERCE
3580 bottles of 100, 592 bottles of 1000
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
AUSAB EIA Diagnostic Kit, Hepatitis B Surface Antigen (Human) (subtypes ad and ay) 100 tests per kit; list no. 9600, U.S. License 43, Recall # B-1404-08
CODE
List 9006-24, Lot number 59238M200, exp. June 11, 2008
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Abbott Park, IL, by letters dated April 21, 2008. Firm initiated recall is ongoing.
REASON
Product is showing a higher than expected number of non-reactive values for low level reactive samples during in-house testing using incubation procedure A (40 degrees C for 2 hours).
VOLUME OF PRODUCT IN COMMERCE
1,398 kits
DISTRIBUTION
Nationwide, Canada, Germany and South Korea
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1425-08
CODE
Unit: 5306266
RECALLING FIRM/MANUFACTURER
Presbyterian Intercommunity Hosp. Inc, Whittier, CA, by letter on October 1, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
______________________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1428-08
CODE
Units: X63844 Part 1; and Part 2
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by telephone on January 12, 2007 and letter dated January 26, 2007. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
_______________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1432-08
CODE
Unit: 030GR18155
RECALLING FIRM/MANUFACTURER
American Red Cross, Northeastern, Ashley, PA, by facsimile on January 24, 2008. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1433-08
CODE
Unit: 72C024801
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by facsimile on September 21, 2007. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-1434-08
CODE
Units: 200423597 Part 1; and Part 2
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lafayette, LA, by telephone on October 5, 2007. Firm initiated recall is complete.
REASON
Blood products, which were identified as being contaminated by the BacT/ALERT 3D system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-1435-08
CODE
Unit: 72C392333
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on September 19, 2007. 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
a) Red Blood Cells Leukocytes Reduced, Recall # B-1429-08;
b) Recovered Plasma, Recall # B-1430-08
CODE
a) and b) Units: 029GF66994; 029GF63631
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic Region, Norfolk, VA, by electronic mail on August 2, 2007 and letter on August 7, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred by another donor center, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
VA, CA
___________________________________
PRODUCT
Recovered Plasma Frozen, Recall # B-1431-08
CODE
Unit: 030GR18155
RECALLING FIRM/MANUFACTURER
American Red Cross, Northeastern, Ashley, PA, by facsimile on January 24, 2008. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY, CA
___________________________________
PRODUCT
a) Platelet Pheresis Leukocytes Reduced, Recall # B-1436-08;
b) Platelet Pheresis Leukocytes Reduced Irradiated, Recall # B-1437-08
CODE
a) Unit: 17FX86495 Part 1;
b) Unit: 17FX86495 Part 2;
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, Saint Paul, MN, by letter on May 19, 2005. Firm initiated recall is complete.
REASON
Blood products, collected under conditions where the sterility of the product may have been compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1438-08
CODE
Units: 6931219, 6791099, 6813885
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on July 22, 2007. Firm initiated recall is complete.
REASON
Blood products, positive for the e-antigen but labeled as e-antigen negative, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO
___________________________________
PRODUCT
ADVIA Centaur Tnl-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Recall # Z-0580-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions Diagnostics, Tarrytown, NY, by e-mail on June 7, 2007 and July 5, 2007.
Manufacturer: Siemens Medical Solutions Diagnostics, East Walpole, MA. Firm initiated recall is ongoing.
REASON
Incorrect results: Falsely elevated Troponin values have been reported which are inconsistent with the patient's clinical picture and test negative by other Troponin assays.
VOLUME OF PRODUCT IN COMMERCE
58,818 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
GE Healthcare Proteus XR/a Radiographic System, Model Number 2259976; previously marketed as the Silhouette FC, Recall # Z-0842-2008
CODE
00000010838HL1, 00000011061HL9, 00000011067HL6, 00000011185HL6, 00000012500HL5, 00000012667HL2, 00000013129HL2, 00000013372HL8, 00000013385HL0, 00000013543HL4, 00000013557HL4, 00000013800HL8, 00000014099HL6, 00000014104HL4, 00000014319HL8, 00000014327HL1, 00000014667HL0, 00000014677HL9, 00000015076HL3, 00000015383HL3, 00000015386HL6, 00000015400HL5, 00000015738HL8, 00000015744HL6, 00000015745HL3, 00000015750HL3, 00000015760HL2, 00000016174HL5, 00000016383HL2, 00000016386HL5, 00000016696HL7, 00000016707HL2, 00000016708HL0, 00000016709HL8, 00000016930HL0, 00000016954HL0, 00000016955HL7, 00000017119HL9, 00000017130HL6, 00000017131HL4, 00000017476HL3, 00000017477HL1, 00000017478HL9, 00000017480HL5, 00000017490HL4, 00000017492HL0, 00000017493HL8, 00000017599HL2, 00000017604HL0, 00000017608HL1, 00000017610HL7, 00000017613HL1, 00000017616HL4, 00000017788HL1, 00000017801HL2, 00000018476HL2, 00000018479HL6, 00000018483HL8, 00000019041HL3, 00000019048HL8, 00000019095HL9, 00000019098HL3, 00000019104HL9, 00000019110HL6, 00000019241HL9, 00000019244HL3, 00000019413HL4, 00000019419HL1, 00000019489HL4, 00000019496HL9, 00000019499HL3, 00000019501HL6, 00000019502HL4, 00000019669HL1, 00000019801HL0, 00000019886HL1, 00000019894HL5, 00000019959HL6, 00000020091HL5, 00000020092HL3, 00000020239HL0, 00000020243HL2, 00000020374HL5, 00000020967HL6, 00000021064HL1, 00000021197HL9, 00000021201HL9, 00000021204HL3, 00000021343HL9, 00000021344HL7, 00000021349HL6, 00000021552HL5, 00000021911HL3, 00000021921HL2, 00000021938HL6, 00000021953HL5, 00000022033HL5, 00000022333HL9, 00000022337HL0, 00000022412HL1, 00000022477HL4, 00000022600HL1, 00000022795HL9, 00000022931HL0, 00000023116HL7, 00000023122HL5, 00000023126HL6, 00000023412HL0, 00000023415HL3, 00000024386HL5, 00000024483HL0, 00000024588HL6, 00000024939HL1, 00000024940HL9, 00000025426HL8, 00000025475HL5, 00000025476HL3, 00000025477HL1, 00000025572HL9, 00000027104HL9, 00000027867HL1, 00000028057HL8, 00000028453HL9, 00000028524HL7, 00000028845HL6, 00000029098HL1, 00000029145HL0, 00000029502HL2, 00000029550HL1, 00000029634HL3, 00000029640HL0, 00000029969HL3, 00000030108HL5, 00000030113HL5, 00000030229HL9, 00000030232HL3, 00000030236HL4, 00000030633HL2, 00000030848HL6, 00000030920HL3, 00000030921HL1, 00000030976HL5, 00000031172HL0, 00000031175HL3, 00000031565HL5, 00000031702HL4, 00000031811HL3, 00000031928HL5, 00000031929HL3, 00000031930HL1, 00000032309HL7, 00000032311HL3, 00000032317HL0, 00000032319HL6, 00000032322HL0, 00000032850HL0, 00000032912HL8, 00000032916HL9, 00000032919HL3, 00000032920HL1, 00000033330HL2, 00000033388HL0, 00000033391HL4, 00000033408HL6, 00000033437HL5, 00000033509HL1, 00000033679HL2, 00000033681HL8, 00000033682HL6, 00000033727HL9, 00000033731HL1, 00000033884HL8, 00000033970HL5, 00000033971HL3, 00000033983HL8, 00000033984HL6, 00000034218HL8, 00000034420HL0, 00000034469HL7, 00000034470HL5, 00000034520HL7, 00000034644HL5, 00000034694HL0, 00000034762HL5, 00000034764HL1, 00000034913HL4, 00000034938HL1, 00000035052HL0, 00000035101HL5, 00000035159HL3, 00000035191HL6, 00000035244HL3, 00000035246HL8, 00000035247HL6, 00000035329HL2, 00000035445HL6, 00000035544HL6, 00000035547HL9, 00000035632HL9, 00000035641HL0, 00000036038HL8, 00000036068HL5, 00000036071HL9, 00000036100HL6, 00000036126HL1, 00000036128HL7, 00000036265HL7, 00000036362HL2, 00000036363HL0, 00000036431HL5, 00000036624HL5, 00000036625HL2, 00000036674HL0, 00000036698HL9, 00000036702HL9, 00000036882HL9, 00000036983HL5, 00000037104HL7, 00000037123HL7, 00000037351HL4, 00000037352HL2, 00000037353HL0, 00000037396HL9, 00000037596HL4, 00000037919HL8, 00000038423HL0, 00000038771HL2, 00000038772HL0, 00000039125HL0, 00000039581HL4, 00000039612HL7, 00000040366HL7, 00000040493HL9, 00000040728HL8, 00000040865HL8, 00000041290HL8, 00000041291HL6, 00000041511HL7, 00000041768HL3, 00000042367HL3, 00000042649HL4, 00000042650HL2, 00000042651HL0, 00000042701HL3, 00000042880HL5, 00000043029HL8, 00000043184HL1, 00000043265HL8, 00000043665HL9, 00000043727HL7, 00000043747HL5, 00000043751HL7, 00000044548HL6, 00000045475HL1, 00000045651HL7, 00000015925HL1, 00000019969HL5, 00000024476HL4, 00000027957HL0, 00000030025HL1, 00000030028HL5, 00000032711HL4, 00000035548HL7, 00000036428HL1, 00000036883HL7, 00000020371HL1, 00000021582HL2, 00000031922HL8, 00000033316HL1, 00000042706HL2, 00000020735HL7, 00000022513HL6, 00000022926HL0, 00000024376HL6, 00000031909HL5, 00000040521HL7, 00000041017HL5, 00000011544HL4, 00000014336HL2, 00000016171HL1, 00000016545HL6, 00000017123HL1, 00000017483HL9, 00000023189HL4, 00000028833HL2, 00000030875HL9, 00000030924HL5, 00000031916HL0, 00000031918HL6, 00000032909HL4, 00000033730HL3, 00000033974HL7, 00000034268HL3, 00000036165HL9, 00000042001HL8, 00000016177HL8, 00000031554HL9, 00000036626HL0, 00000013383HL5, 00000014323HL0, 00000019485HL2, 00000020232HL5, 00000010836HL5, 00000019679HL0, 00000023546HL5, 00000023547HL3, 00000030926HL0, 00000041996HL0, 00000042388HL9, 00000042537HL1, 00000011063HL5, 00000015391HL6, 00000017138HL9, 00000021058HL3, 00000030918HL7, 00000040086HL1, 00000010328HL3, 00000013375HL1, 00000014335HL4, 00000015065HL6, 00000015081HL3, 00000015747HL9, 00000016371HL7, 00000016701HL5, 00000017125HL6, 00000017481HL3, 00000019482HL9, 00000019486HL0, 00000019678HL2, 00000019680HL8, 00000019788HL9, 00000020081HL6, 00000020224HL2, 00000021639HL0, 00000022032HL7, 00000023118HL3, 00000023181HL1, 00000024432HL7, 00000029259HL9, 00000031908HL7, 00000031914HL5, 00000032231HL3, 00000032897HL1, 00000033724HL6, 00000033725HL3, 00000033968HL9, 00000034260HL0, 00000034459HL8, 00000034462HL2, 00000034783HL1, 00000035377HL1, 00000035378HL9, 00000036563HL5, 00000037254HL0, 00000038190HL5, 00000016175HL2, 00000019042HL1, 00000013796HL8, 00000011182HL3, 00000032313HL9, 00000012475HL0, 00000020222HL6, 00000029743HL2, 00000033726HL1, 00000020732HL4, 00000020737HL3, 00000012674HL8, 00000021551HL7, 00000031689HL3, 00000010651HL8, 00000015757HL8, 00000022520HL1, 00000015082HL1, 00000015153HL0, 00000021644HL0, 00000013373HL6, 00000015158HL9, 00000022606HL8, 00000022607HL6, 00000024489HL2, 00000024590HL2, 00000024671HL0, 00000024689HL2, 00000030446HL9, 00000030460HL0, 00000030927HL8, 00000036429HL9, 00000015387HL4, 00000039893HL3, 00000039895HL8, 00000039962HL6, 00000040002HL8, 00000040072HL1, 00000040164HL6, 00000040167HL9, 00000022402HL2, 00000036266HL5, 00000036914HL0, 00000037252HL4, 00000013564HL0
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, by a Field Modification Instruction and visit beginning December 2007.
Manufacturer: GE Hangwei Medical Systems Co LTD, Beijing Econ & Tech Dev Zone, China. Firm initiated recall is ongoing.
REASON
The warning label that is required by 21 CFR 1020.30(j) was not on the control console of the Proteus XR/a Radiographic X-ray System, Model 2259976.
VOLUME OF PRODUCT IN COMMERCE
400 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator,
Catalog Number: 255100; Product Number: M0062551000, Onset Medical,
Recall # Z-0905-2008;
b) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator,
Catalog Number: 255101; Product Number: M0062551010, Recall # Z-0906-2008;
c) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator,
Catalog Number: 255102; Product Number: M0062551020, Recall # Z-0907-2008;
d) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator,
Catalog Number: 255103; Product Number: M0062551030, Recall # Z-0908-2008;
e) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator,
Catalog Number: 255104; Product Number: M0062551040, Recall # Z-0909-2008;
f) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/46, Ureteral dilator,
Catalog Number: 255105; Product Number: M0062551050, Recall # Z-0910-2008;
g) Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator,
Catalog Number: 255106; Product Number: M0062551060, Recall # Z-0911-2008;
h) Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator,
Catalog Number: 255107; Product Number: M0062551070, Recall # Z-0912-2008;
i) Pathway Balloon Expandable Ureteral Access Sheath- 12/15/46, Ureteral dilator,
Catalog Number: 255108; Product Number: M0062551080, Recall # Z-0913-2008
CODE
a) Lot numbers: W03-1606, W03-1649, W03-1700, W03-1702, W03-1924,
W03-2077, W03-2143, W03-2277, W03-2283;
b) Lot numbers: W03-1527, W03-1579, W03-1587, W03-1595, W03-1623, W03-1644,
W03-1753, W03-1786, W03-1787, W03-1813, W03-1832, W03-1938, W03-2108,
W03-2110, W03-2139, W03-2271, W03-2278, W03-2279, W03-2280, W03-2535,
W03-2589;
c) Lot numbers: W03-1613, W03-1747, W03-1805, W03-1945, W03-2111, W03-2272,
W03-2484, W03-2577;
d) Lot numbers: W03-1473, W03-1474, W03-1909, W03-2055, W03-2112, W03-2144,
W03-2232, W03-2284, W03-2232, W03-2391, W03-2464, W03-2579;
e) Lot numbers: W03-1482, W03-1491, W03-1508, W03-1524, W03-1740, W03-1917,
W03-2107, W03-2113, W03-2214, W03-2216, W03-2236, W03-2239, W03-2240,
W03-2285, W03-2354, W03-2410, W03-2446, W03-2457, W03-2483, W03-2580;
f) Lot numbers: W03-1464, W03-1767, W03-2106, W03-2215, W03-2241, W03-2242,
W03-2275, W03-2470, W03-2566;
g) Lot numbers: W03-2337, W03-2359, W03-2392, W03-2553, W03-2554, W03-2590;
h) Lot numbers: W03-2339, W03-2342, W03-2362, W03-2382, W03-2409, W03-2431,
W03-2434, W03-2436, W03-2439, W03-2479, W03-2482, W03-2550, W03-2555,
W03-2581, W03-2591;
i) Lot Number: W03-2341, W03-2357, W03-2395, W03-2578
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on November 29, 2007.
Manufacturer: Onset Medical Corporation, Irvin, CA. Firm initiated recall is ongoing.
REASON
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
VOLUME OF PRODUCT IN COMMERCE
1,998 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
AMO VISX STAR Excimer Laser System 0030-4864 Chair component of the System 0030-2381. Each chair also has a serial number, which is the same as the serial number assigned to the system it is part of, Recall # Z-1139-2008
CODE
Serial Numbers: 2129 2146 2181 2197 3028 3030 3031 3036 3480 3624 5346 5635 3751 3863 5345 5088 3113 5065 3938 2158 2177 2204 2205 3254 3387 3397 3754 3937 5030 5122 3023 3194 3435 3456 3732 3830 5027 5283 5313 5334 5382 5456 5566 5606 5643 3037 3122 3130 3233 3246 3874 5006 5021 5032 5125 5224 5415 5671 3574 5306 5695 3816 2200 3029 3284 3293 3528 3536 3697 3712 3731 3802 3840 3927 5012 5014 5034 5064 5079 5151 5153 5154 5175 5231 5267 5287 5307 5317 5410 5559 5573 5656 5720 5779 3884 5649 3314 3974 5495 3241 and 5127
RECALLING FIRM/MANUFACTURER
VISX Incorporated, a Subsidiary of AMO Inc., Santa Clara, CA, by letter on December 13, 2007. Firm initiated recall is ongoing.
REASON
Firm received two complaints (including one injury complaint) associated with the movement of the VISX chair while in the patient loading ("fully swung out" unlocked) position under an IntraLase FS laser.
VOLUME OF PRODUCT IN COMMERCE
1,853 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, Recall # Z-1140-2008
CODE
Serial Numbers: 1864742, 1869148, 1869619, 1870824, 1870825, 1872061, and 1875317.
RECALLING FIRM/MANUFACTURER
Recalling Firm: B & K Medical Systems, Inc., Wilmington, MA, by letter on January 23, 2008.
Manufacturer: B-K Medical A/S, Herlev, Denmark. Firm initiated recall is ongoing.
REASON
Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
MA, MI, PA, TX, and OR
___________________________________
PRODUCT
a) CalMed Pericardial Sump, with 1/8"/0.3175 cm Connector Single Use Only.
Do Not Reuse. Catalog Number REF SU-20601; Recall # Z-1175-2008;
b) CalMed Pericardial Sump, with 1/4"/0.635 cm Connector, Single Use Only. Do Not
Reuse; Catalog Number REF SU-20602; Recall # Z-1176-2008;
c) CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. Catalog
Number REF SU-20802; Recall # Z-1177-2008
CODE
a) Lot Number S03482;
b) Lot Numbers: S040846 S040754 S040914 S041006 S041122 S050061NS S050232
S050233 S050329 S050335NS S050416NS S050538NS S050741 S050759NS
S050766NS S050858 S050923NS S050943NS S051041 S051130 S051151
S051175 S051275NS S051318NS S051356NS S051402NS S051490 S051511
S051560NS S051582NS S051596NS S051677ES S051844NS S051881 S051906ES
S051925 S052007NS S052142NS S052193NS S052295 S052338NS S060045
S060092NS S060202 S060285 S060401NS S060402NS S060454NS;
Lot No. S060492NS S060683NS S060965NS S061010NS S061226 S061434
S061441NS S061513NS S061695NS S061760NS S061838NS S061916 S062015NS
S062055NS S062132 S070135NS S070252NS S070324 S070482NS S070501NS
S070633 S070820NS S070870NS S070882 S070998 S071002NS S071456NS
S071457NS S071458 S071459NS S071460NS S071534 S071606 S071607 S071688
S071731NS S071766 S071989 S072100NS S072121NS, and S072133NS;
c) Lot Numbers: S040870 S041515 S050537 S050907 S050919 S051982 S052118
S052325 S060056 S060158 S060909 S060924 S070307 S071047 S071462NS
S071463 S071620 S071754 and S071985
RECALLING FIRM/MANUFACTURER
California Medical Laboratories, Inc., Costa Mesa, CA, by letters on January 24, 2008. Firm initiated recall is ongoing.
REASON
Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.
VOLUME OF PRODUCT IN COMMERCE
31,124 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Presource Standard Sterile OR Scissors; straight scissors, S/B, 5.5", made in Pakistan; individually packaged in rigid styrene roll stock with a tyvek top, 50 units per case; Catalog #SSI-0003; Recall # Z-1178-2008
CODE
Mfg Date 10/15/07, Order no. 247610
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, McGaw Park, IL, by letter dated February 12, 2008.
Manufacturer: Convertors De Mexico, S.A. De C.V., Ciudad, Juarez, Mexico. Firm initiated recall is ongoing.
REASON
The product has the potential of being non-sterile.
VOLUME OF PRODUCT IN COMMERCE
16 cases
DISTRIBUTION
KS, MO
___________________________________
PRODUCT
a) U19 Socketed Integrated Circuit ("U19 IC") on the logic board of Alaris Pump
modules (aka. Medley Pump modules), Model 8100 built on or before September 8,
2005. Recall # Z-1710-2008
b) Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System
modules built on or before March 26, 2004: (1) Alaris PC point-of-care unit ("PC
Unit") (Model 8000)* (a.k.a. Medley PC Unit), (2) Alaris Pump Module (Model
8100) (a.k.a. Medley Pump Module), (3) Alaris Syringe Module (Model 8110)
(a.k.a. Medley Syringe Module), (4) Alaris PCA Module (Model 8120) (a.k.a.
Medley PCA Module), (5) Alaris SpO2 Module (Models 8210) (a.k.a. Medley
SpO2 Module) with Nellcor technology, and (6) Alaris SpO2 Module (Models
8220) (a.k.a. Medley SpO2 Module) with Masimo technology,
Recall # Z-1711-2008;
c) U9 Socket Integrated Circuit ("U9 IC") on the display board of the following
Alaris System modules built on or before October 4, 2005: (1) Alaris Syringe
module (Model 8110) (a.k.a. Medley Syringe module) (2) Alaris PCA module
(Model 8120) (a.k.a. Medley PCA module), Recall # Z-1712-2008
CODE
The firm’s website has a list of the serial numbers for the affected devices: http://www.cardinal.com/alarisnotice/
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health 303 Inc., dba Alaris Products, San Diego, CA, by letter on April 10, 2008.
Manufacturer: Cardinal Health 303 dba Cardinal Health, San Diego, CA. Firm initiated recall is ongoing.
REASON
a) A channel error on an affected Alaris System module will stop an active infusion
(or monitoring) with an audible and visual alarm. Channel errors due to failures of
the U19 Socketed Integrated Circuits (U19 IC) on the logic board of the Alaris Pump
module ("Pump module"). The user will be required to replace the affected module.
b) A channel error on an affected Alaris System module will stop an active infusion
(or monitoring) with an audible and visual alarm. Channel errors with the Alaris
System due to the Inter-Unit Interface (IUI) connectors on all Alaris System modules
(manufactured on or before March 26, 2004). Grey Inter-Unit Interface Connectors
("IUI") on the following Alaris System modules built on or before March 26, 2004:
(1) Alaris PC point-of-care unit ("PC Unit") (Model 8000)* (a.k.a. Medley PC Unit),
(2) Alaris Pump Module (Model 8100) (a.k.a. Medley Pump Module),
(3) Alaris Syringe Module (Model 8110) (a.k.a. Medley Syringe Module),
(4) Alaris PCA Module (Model 8120) (a.k.a. Medley PCA Module),
(5) Alaris SpO2 Module (Models 8210) (a.k.a. Medley SpO2 Module) with Nellcor
technology, and
(6) Alaris SpO2 Module (Models 8220) (a.k.a. Medley SpO2 Module) with Masimo
technology. The user will be required to replace the affected module.
c) A channel error on an affected Alaris System module will stop an active infusion (or
monitoring) with an audible and visual alarm. Channel errors due to failure of the U9
Socketed Integrated Circuits (U9 IC) on the display board of the Alaris Syringe
Module ("Syringe module") and Alaris PCA module ("PCA module") for modules
manufactured on or before October 4, 2005. The user will be required to replace the
affected module.
VOLUME OF PRODUCT IN COMMERCE
a) 85,286
b) 77,515
c) 8,286
DISTRIBUTION
Nationwide and Internationally
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS I
___________________________________
PRODUCT
a) 12% Equinator Integrity Horse Pellets, Bulk, Recall # V-044-2008;
b) 12% Equinator Integrity Horse Pellets, 50 lb bag, Recall # V-045-2008
CODE
a) Order # 141424;
b) Order # 141418, Stamped Dec 07, 2007
RECALLING FIRM/MANUFACTURER
Central Connecticut Cooperative Farmers Association, Manchester, CT, by telephone on December 20, 2007 and December 21, 2007. Firm initiated recall is complete.
REASON
Horse feed contaminated with medication not approved for horses was distributed.
VOLUME OF PRODUCT IN COMMERCE
5320 lbs bulk + 11/50 lb bags = 5870 lbs total
DISTRIBUTION
CT
___________________________________
PRODUCT
a) Reliance Hay Stretcher Pelleted Horse Feed. The product is sold in a 50 lb bag,
Recall # V-207-2008;
b) Select 12P Pelleted Hose Feed. The product is sold in 50 lb bags,
Recall # V-208-2008;
c) Sheep Feed Pellets. The product is sold in 50 lb bags, Recall # V-209-2008
CODE
a) Lot: G8015;
b) Lot: G8018;
c) Lot: G7360
RECALLING FIRM/MANUFACTURER
Southern States dba Cooperative Milling, Inc., Gettysburg, PA, by telephone on March 28, 2008. Firm initiated recall is ongoing.
REASON
Elevated aflatoxin levels
VOLUME OF PRODUCT IN COMMERCE
1,142 bags
DISTRIBUTION
DE, MD, NH, NJ, NY, PA and VA
END OF ENFORCEMENT REPORT FOR JUNE 11, 2008
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