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U.S. Department of Health and Human Services

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Enforcement Report for August 1, 2007

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. 

August 1, 2007
07-31

 

RECALLS AND FIELD CORRECTIONS:  FOODS AND COSMETICS - CLASS I

___________________________________
PRODUCT
Sentinel Shark Cartilage 750mg, UPC 28245 00313 6, Recall # F-449-7
CODE
Lot number 064951, expiration date 07 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Action Labs, Inc., Anaheim, CA, by letters starting on May 23, 2007 and by press release on June 6, 2007.
Manufacturer: NBTY Inc., Bohemia, NY. Firm initiated recall is complete.
REASON
Testing performed recently at NBTY, Inc. (the manufacturer) shows that the recalled capsules have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1190 bottles of 60 capsules each
DISTRIBUTION
CA and Hong Kong

RECALLS AND FIELD CORRECTIONS:  FOODS AND COSMETICS - CLASS II

___________________________________
PRODUCT
Rugby Oral Electrolyte Solution, Unflavored, in one liter polypropylene bottles, Recall # F-447-7
CODE
UN61292 and UN61294
RECALLING FIRM/MANUFACTURER
Unico Holdings, Inc., Lake Worth, FL, by e-mail and letters on March 22, 2007 and March 28, 2007. Firm initiated recall is ongoing.
REASON
Products may be contaminated with Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
5,712 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT
a) ShiR Fresh Anticavity Fluoride Toothpaste, Mint Flavor, Net Weight 9 oz., labeled ingredients
    include: Sodium Monofluorophosphate 0.70%, Glycerin, Sorbitol. Made in China,
    Recall # D-845-2007
b) ShiR Fresh Anticavity Fluoride Toothpaste, Ice ShiR Mint Flavor, Net Weight 6.4 oz.,
    labeled ingredients include: Sodium Monofluorophosphate 0.70%, Glycerin, Sorbitol. 
    Made in China, Recall # D-846-2007;
c) ShiR Fresh Anticavity Fluoride Toothpaste, Cool ShiR Mint flavor, Kids Mint,
    Net Weight 6.4 oz., labeled ingredients include: Sodium Monofluorophosphate 0.70%,
    Glycerin, Sorbitol. Made in China, Recall # D-847-2007
CODE
a) Lots: 777A, 777B, 777C, 777D;
b) Lot: 2471A;
c) Lot: 2471B
RECALLING FIRM/MANUFACTURER
Gold City Enterprise, LLC, Aventura, FL, by press release, letter and telephone on June 9, 2007.
REASON
Toothpaste from China contains the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
155,880 tubes
DISTRIBUTION
FL
___________________________________
PRODUCT
OXYCODONE and ASPIRIN Tablets USP 4.5 mg -0.38 mg ** -325 mg Tablet 100 tablets RX only, Recall # D-849-2007
CODE
Batch# M920110 Lot# L6E0600A Exp Date 9/07; Batch# M947980 Lot# L6E0602B Exp Date 12/07; Batch# M975710 Lot# L6G0851A Exp Date 3/08 and Batch# 992490 Lot# L6K1209A Exp Date 4/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, Zanesville, OH, by letters on July 9, 2007.
Manufacturer: Watson Laboratories Inc., Corona, CA. Firm initiated recall is ongoing
REASON
Product may not meet aspirin dissolution specifications through the labeled expiration dates.
VOLUME OF PRODUCT IN COMMERCE
4,700 tablets
DISTRIBUTION
CA and MA

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT
Little Teethers by Little Remedies, Homeopathic Teething Tablets, 150 count bottles, OTC, Active Ingredients: Belladona 3x HPUS (0.0003% alkaloids), Calcarea Phosphorica 3x HPUS, Chamomilla 3x HPUS, Coffea Cruda 3x HPUS. --- NOTE: this product is homeopathic and is to be taken orally, specifically sublingual or dissolved in a teaspoon of water for administration orally, UPC 7-56184-12090-3, Recall # D-843-2007
CODE
Lots 14789, 14908, 14933, 14966, 15010, 15028
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtech Products, Inc., Irvington, NY, by letters dated June 8, 2007.  
Manufacturer: Washington Homeopathic Products, Inc., Berkeley Springs, WV. Firm initiated recall is ongoing.
REASON
Failed Dissolution; product failed to dissolve instantly as labeled
VOLUME OF PRODUCT IN COMMERCE
1,205 cases (36 – 150 tablet bottles per case)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) fougera Mupirocin Ointment USP, 2%, Net. Wt. 22 grams tubes (NDC 0168-0352-22);
b) Foilpacs (NDC 0168-0352-09), Net Wt. 72 x 0.9 g (1/32 Oz), Rx only, Recall # D-844-2007
CODE
a) Lots: T416 (exp. 8/07), X579 (exp. 7/08), X580 (exp. 11/08), U221(exp. 12/07),
    U323 (exp. 12/07);
b) Lots: T298 (exp. 8/07), T299 (exp. 8/07), U010 (exp. 11/07), U011 (exp. 11/07),
    U239 (exp. 12/07), U345 (exp. 1/08)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Altana Inc., Melville, NY, by letters dated May 2, 2007.
Manufacturer: Altana Inc., Hicksville NY. Firm initiated recall is ongoing.
REASON
The product is subpotent.
VOLUME OF PRODUCT IN COMMERCE
9 g foil packs: 59,832 units; 22 g tubes: 173,805 units
DISTRIBUTION
Nationwide, PR, and Bermuda

___________________________________
PRODUCT
Metadate® ER Tablets (methylphenidate hydrochloride extended-release tablets, USP), 10 mg, 100 Tablets, Rx only, NDC 53014-593-07. --- Please note: There was a labeling change between the packaging of lot 40641 and 41837, so there are 2 labels: one lists Celltech Pharmaceuticals, Inc., (now known as UCB Manufacturing, Inc.); the other lists UCB, Recall # D-848-2007
CODE
Lots 41837 (expiration date 09/08) and 40641 (expiration date 09/08)
RECALLING FIRM/MANUFACTURER
UCB Manufacturing, Inc., Rochester, NY, by letters on July 13, 2007. Firm initiated recall is ongoing.
REASON
Failure to meet dissolution specification.
VOLUME OF PRODUCT IN COMMERCE
1,531 – 100 count bottles
DISTRIBUTION
MA, NJ, NY, PA, VA, NC, TN, KY, OH, MN, ND, IL, MO, CA, HI, WA, Puerto Rico, and St. Thomas
___________________________________
PRODUCT
Nystatin Oral Suspension, USP, 100,000 units per mL, Rx only, 1 pint (473mL) and 60mL bottles, NDC 0603-1453-47, Recall # D-850-2007
CODE
Lot Numbers: L094B07A, L094B07B, L113B07A
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC, Huntsville, AL, by letter on June 20, 2007. Firm initiated recall is ongoing.
REASON
Failed Content Uniformity Requirements.
VOLUME OF PRODUCT IN COMMERCE
41,117 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1298-07
CODE
Unit: 22LZ07820
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey, Philadelphia, PA, by letter on August 22, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1321-07
CODE
Unit: 231534531 (spit product)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on January 15, 2005. Firm initiated recall is complete.
REASON
Blood products, which tested non-reactive for anti-HIV-1, HBsAg, anti- HCV, anti-HBc, anti-HTLV-I, and syphilis, but were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MO, and MT
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1329-07
CODE
Unit: 231539105
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on January 15, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who reported an illness a day after the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MT
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1334-07
CODE
Unit: 04Z29733
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New England Region, Dedham, MA, by fax and follow-up letter on December 13, 2006. 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
NY
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1335-07;
b) Cryoprecipitated, Recall # B-1336-07
CODE
a) and b) Unit: 5598410
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on September 15, 2005 and letter on October 5, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and LA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1345-07
CODE
Unit: 3184945
RECALLING FIRM/MANUFACTURER
Lifesource, Glenview, IL, by telephone on January 19, 22, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1347-07
CODE
Unit: FT07509
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by fax in June 25, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had resided in a malaria endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, B-1348-07
CODE
Units: 32GP21021, 32GP20229, 32GP21583, 32GP20675, 32GP21767, 32GP22041, 32GP22237, 32GP22487, 32GP22983, 32GP23118, 32GP23410, 32GP23507, 32GP23724, and 32GP24209
RECALLING FIRM/MANUFACTURER
American Red Cross, Madison, WI, by letter on March 7, 2003. 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
14 units
DISTRIBUTION
IL, IA, and WI
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1349-07;
b) Platelets, Recall # B-1350-07;
c) Red Blood Cells Leukocytes Reduced, Recall # B-1351-07
CODE
a) and b) Unit: Unit LS97829;
b) Unit: LS95156
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by fax on June 23, 2003. 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
3 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1352-07
CODE
Unit: 9862491 (split product)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on May 5, 2006 and letter on June 7, 2006. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1353-07
CODE
Unit: 9885009
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on July 13, 2006 and letter dated July 14, 2006. 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
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1354-07
CODE
Unit: 9975273 (split product)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on July 1, 2006. 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
FL
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1355-07;
b) Platelets, Recall # B-1356-07
CODE
a) Units: 4443412 and 4444541
b) Unit: 4444541
RECALLING FIRM/MANUFACTURER
Lifesource, Glenview, IL, by telephone on January 10, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had resided in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT
a) Platelets Pooled Leukocytes Reduced, Recall # B-1337-07;
b) Platelets Pooled Irradiated, Recall # B-1338-07
CODE
a) Units: KR17627, KR17643, KR17651, KR17653, KR17654, KR17658, KR17647, KR17648,
    KR17641, KR17645, KR17650, and KR17655;
b) KR17637, KR17630, and KR17652
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by fax on October 1, 2003. Firm initiated recall is complete.
REASON
Blood products, which were stored in inadequate storage conditions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
WI

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS I

___________________________________
PRODUCT
Thoratec TLC-II Portable VAD Driver. Component (pneumatic) driver of Thoratec Ventricular Assist Device system; Catalog number 20010-0000-032, Recall # Z-1108-2007
CODE
All units manufactured or serviced since August, 2005.
RECALLING FIRM/MANUFACTURER
Thoratec Corp., Pleasanton, CA, by letters on June 8, 2007. Firm initiated recall is ongoing.
REASON
Component Failure; Device Failure without warning. Due to premature wear-out of the compressor motor, VAD support for the patient's circulatory system may fail without warning.
VOLUME OF PRODUCT IN COMMERCE
378 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-000, Recall # Z-1109-2007
CODE
Expiration dates January 2007 to October 2009. PVAD serial numbers 10745 or less that were shipped after January 2004. Units shipped prior to January 2004 have exceeded their expiration date.*
RECALLING FIRM/MANUFACTURER
Thoratec Corp., Pleasanton, CA, by letters on March 30, 2007. Firm initiated recall is ongoing.
REASON
Incorrect collet nut assembly (inadvertent use of the incorrect (Black) collet nut) during surgical implantation (wrong size collet nut) to secure the inflow cannula to the PVAD has resulted in patient deaths.
VOLUME OF PRODUCT IN COMMERCE
2,484 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) Baxter Flo-Gard 6201, SIngle Channel, Volumetric Infusion Pump; Product Code # 2M8063,
    Recall # Z-1111-2007;
b) Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Product code # 2M8064,
    Recall # Z-1112-2007;
c) Baxter Colleague Single Channel Volumetric Infusion Pumps; Made in Singapore;
    Product codes 2M8151 and 2M8161 (Colleague CX), Recall # Z-1113-2007;
d) Baxter Colleague Triple Channel Volumetric Infusion Pumps; Made in Singapore;
    Product codes 2M8153 and 2M8163 (Colleague CX Triple), Recall # Z-1114-2007
CODE
a) Serial numbers: 312424FB, 401424FB, 402089FB, 405111FB, 406060FB, 406067FB, 406154FB,
    406155FB, 410334FB, 504036FB, 504053FB, 504061FB, 504378FB, 505328FB, 5090200FB,
    5120672FB, 5120673FB, 6010044FB, 6050216FB, 7090392FB, 72000920, 72002220, 7202164Y,
    7202357Y, 73041636, 73043106, 73044076, 73045746, 73048047, 73048607, 8070182FB,
    93001467, 93007507, 10010241FB, 10100618FB, 10100652FB, 11010414FB, 11030373FB,
    11050043FB, 11050487FB, 11050505FB, 11060149FB, 12060080FB, 13020041FB, 13040040FB,
    13090060FB, 14020080FB, 13050172FB, 14080040FB;
b) Serial numbers: RA00449, RA00771, RA01093, RA01103FA, RA01143, RA01212FA,
    RA01241FA, RA01352, RA01392, RA01471FA, 4020417FA, 4110026FA, 4110599FA,
    4111648FA, 5010398FA, 5010588FA, 5010892FA, 5030542FA, 5031363FA, 5041317FA,
    5041836FA, 5050032FA, 5101954FA, 5111071FA, 5111215FA, 5111217FA, 6020538FA,
    6051302FA, 6110083FA, 6110621FA, 6110976FA, 6112818FA, 6113536FA, 6120726FA,
    6120952FA, 6121014FA, 6121201FA, 6121249FA, 62004506, 62009976, 62013806, 62020266,
    62067349, 62069349, 6208698X, 63106801, 63111022, 63111672, 63157766, 63159996, 63173758,
    7120494FA, 8020914FA, 8030070FA, 8060094FA, 8080471FA, 8090732FA, 8090762FA,
    8111587FA, 8111640FA, 83003592, 83039198, 83044518, 83055250, 83064210, 83069140,
    9030584FA, 9030593FA, 9110819FA, 10091327FA, 10091426FA, 10091428FA, 10110600FA,
    10111225FA, 10111396FA, 10112596FA, 10113463FA, 10113550FA, 10113557FA, 10120142FA,
    11030108FA, 11030281FA, 11030908FA, 11031331FA, 11042552FA, 11042740FA, 11042815FA,
    11051333FA, 11052654FA, 11052741FA, 11052809FA, 11052957FA, 11061064FA, 11070997FA,
    11072099FA, 11081754FA, 11100082FA, 11111119FA, 11120281FA, 11120313FA, 11120327FA,
    11120346FA, 12020834FA, 12010409FA, 12031733FA, 12040163FA, 12041054FA, 12060362FB,
    12060972FA, 12061359FA, 12061727FA, 12070800FA, 12080863FA, 12090274FA, 12100402FA,
    12101819FA, 12102195FA, 12102656FA, 12102742FA, 12102862FA, 12120472FA, 12121033FA,
    13010030FA, 13010283FA, 13070260FA, 13070316FA, 13080047FA, 13100967FA, 13101196FA,
    13110190FA, 14010668FA, 14050871FA, 14071117FA, 14071128FA, 14071153FA, 14071166FA,
    14091581FA, 14091796FA, 14020391FA, 14020002FA, 15013155FA, 15013208FA, 15050126FA,
    15050608FA;
c) Serial numbers: 7060630CS, 7091003CS, 7100074CS, 7101610CS, 7101754CS, 7101947CS,
    7102029CS, 7102043CS, 7102056CS, 7102976CS, 7103384CS, 7103450CS, 7103737CS,
    7104534CS, 7110708CS, 7111160CS, 7114751CS, 8025117CS, 8033038CS, 8034055CS,
    8036103CS, 8036952CS, 8037288CS, 8037418CS, 8037767CS, 8038576CS, 8050639CS,
    8062446CS, 8101582CS, 8123500CS, 9011294CS, 9011382CS, 9040234CS, 9050235CS,
    9052543CS, 9052860CS, 9052868CS, 9061024CS, 9060401CS, 9081657CS, 10040692CS,
    10050631CS, 10085122CS, 10085344CS, 10091612CS, 10115681CS, 10120093CS, 11011891CS,
    11031040CS, 11051239CS, 11051470CS, 11051590CS, 11060100CS, 11060787CS, 11081213CS,
    11081462CS, 11081472CS, 11081845CS, 11081965CS, 11082074CS, 11102879CS, 12010726CS,
    12030030CS, 12030494CS, 12030551CS, 12041070CS, 12060249CS, 12070800CS, 12090958CS,
    12101203CS;
    Serial numbers: 11121847CC, 12030260CC, 12051059CC, 12051216CC, 12060422CC,
    12080903CC, 12090295CC, 12090724CC, 12090977CC, 12091057CC, 12091103CC,
    12091366CC, 12091438CC, 12091453CC, 12091477CC, 12091546CC, 12091587CC,
    12091588CC, 12100411CC, 12100787CC, 12101449CC, 12110501CC, 12110527CC,
    12120051TC, 12120703CC, 12121224TC, 13031136CC, 13031246CC, 13031716CC,
    13040152CC, 13050391CC, 13051061CC, 13051455CC, 13051498CC, 13070100CC,
    13070141CC, 13080637CC, 13081576CC, 13081578CC, 13081588CC, 13081695CC,
    13090217CC, 13090339CC, 13091438CC, 13091479CC, 13091480CC, 13091501CC,
    13091554CC, 13091641CC, 13100008CC, 13100014CC, 13100022CC, 13100029CC,
    13100035CC, 13100059CC, 13100060CC, 13100653CC, 13100733CC, 13100774CC,
    13100781CC, 13100880CC, 13101357CC, 13120100CC, 13120249CC, 13120738CC,
    13121400CC, 14060065CC, 14090320CC, 14100170CC, 14112888CC, 14112908CC,
    14113000CC, 14113068CC, 14113097CC, 14120817CC, 14122281CC, 15030727CC,
    15031819CC;
d) Serial numbers: 8071160CT, 8071419CT, 8071460CT, 8071630CT, 8071676CT, 8110465CT,
    8110774CT, 8120247CT, 9010300CT, 9040241CT, 9050062CT, 9050857CT, 9070981CT,
    9080100CT, 9100108CT, 10010454CT, 10060596CT, 10082498CT, 10105657CT, 10115474CT,
    11050804CT, 11070179CT, 11090085CT, 11090787CT, 11101453CT, 12040018CT, 12080251CT,
    12090380CT, 13070011CT;
    Serial numbers: 11040006TC, 11110369TC, 11110524TC, 11110903TC, 11120155TC, 11120602TC,
    12010132TC, 12010139TC, 12010212TC, 12040347TC, 12040406TC, 12050073TC, 12050471TC,
    12060559TC, 12060592TC, 12070054TC, 12070095TC, 12080203TC, 12080537TC, 12080556TC,
    12090356TC, 12090444TC, 12090324TC, 12090534TC, 12090807TC, 12090808TC, 12100610TC,
    12100434TC, 12100589TC, 12110134TC, 12110279TC, 12120513TC, 12120517TC, 13020058TC,
    13040146TC, 13040567TC, 13050246TC, 13050308TC, 13050876TC, 13050896TC, 13050975TC,
    13060359TC, 13060455TC, 13070124TC, 13070173TC, 13070192TC, 13070224TC, 13070835TC,
    13070868TC, 13080319TC, 13081000TC, 13091208TC, 13091388TC, 13100605TC, 13110651TC,
    13120024TC, 14060090TC, 14060125TC, 14060486TC, 14070276TC, 14070282TC, 14070286TC,
    14070288TC, 14070291TC, 14070328TC, 14070330TC, 14070334TC, 14070337TC, 14070344TC,
    14080003TC, 14080037TC, 14080041TC, 14080046TC, 14080068TC, 14080096TC, 14080117TC,
    14082180TC, 14110267TC, 14110418TC, 14110433TC, 14110446TC, 14110459TC, 14110499TC,
    14110685TC, 14110865TC, 14120461TC, 15040254TC, 15040255TC, 15040404TC
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by telephone on June 21, 2007,
Manufacturer:  Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is ongoing.
REASON
Falsified Repair/Test and Inspection records: Pumps submitted for repair or service may not have been properly repaired or serviced before being returned to the customer.
VOLUME OF PRODUCT IN COMMERCE
534 pumps
DISTRIBUTION
Nationwide and Alaska

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT
a) Gebauer's Pain Ease Mist Spray- Topical Anesthetic Skin Refrigerant -is a vapocoolant
    (skin refrigerant) packed in an aerosol container. Rx only-103.5ml (3.5 fl. oz.) can.
    Product Number 0386-0008-02), Recall # Z-1057-2007;
b) Gebauer's Spray and Stretch Fine- Stream Topical Anesthetic Skin Refrigerant -is intended
    for topical application to skin for use in controlling pain associated with injections and the
    temporary relief of minor sports injuries. Rx only- 3.5 fl. oz. (103.5ml) can. Product
    Number 0386-0004-04, Recall # Z-1058-2007;
c) Gebauer's Instant Ice Mist- is used like ice for the temporary relief and reduction of minor pain
    and swelling from sprains, strains, bruising, contusions or minor sports injuries. 3.5 fl. oz. (103.5ml)
    can. (Product Number: 0386-0010-05), Recall # Z-1059-2007;
d) Gebauer's Instant Ice Medium Stream for temporary relief and reduction of minor pain and
    swelling from sprains, strains, bruising, contusions or minor sports injuries.-3.5 fl. oz. (103.5ml)
    can. (Product Number-0386-0010-01), Recall # Z-1060-2007;
e) Pain Ease Medium Stream -Topical Anesthetic Skin Refrigerant is a vapocoolant (skin refrigerant)
    packed in an aerosol container. Rx only. 103.5ml (3.5 fl. oz.) can. (Product Number-0386-0008-03),
    Recall # Z-1061-2007;
f) Gebauer's Pain Ease Sample Spray -Topical Anesthetic Skin Refrigerant is a vapocoolant
    (skin refrigerant) packed in an aerosol container, Rx only, 30 mL(1.0 fl. oz.) can.
    (Product Number-0386-0008-01), Recall # Z-1062-2007
CODE
a) Lot numbers 4256 expires 08-08; 4257 expires 10-08 and 4258 expires 12/08;
b) Lot Numbers: 8019 expires 08-08; 8020 expires 09-08; 8021 expires 10-08
    and 8022 expires 12/08;
c) Lot number 4009 expires 08-08; 4010 expires 12/08;
d) Lot numbers6015 expires 10-08 and 6016 expires 11/08;
e) Lot numbers 6257 expires 08-08; 6258 expires 09-08 and 6259 expires 10/08;
    6260 expires 11-08 and 6261 expires 12/08;
f) Lot number 9253 expires 11-08
RECALLING FIRM/MANUFACTURER
Manufacturer: Gebauer Company, Cleveland, OH, by letter on April 17, 2007. Firm initiated recall is ongoing.
REASON
Mold contamination
VOLUME OF PRODUCT IN COMMERCE
41,499 aerosol cans
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) ALFA’ II Modular Femoral Revision Stem Porous Coated; Size 6; Length: 200mm;
    Diameter: 18.0mm; Catalog # 651-06-180; component of the ENCORE Hip System;
    Single Use, Sterile; Recall # Z-1063-2007;
b) ALFA’ II Modular Femoral Revision Stem Porous Coated; Size 7; Length 200mm;
    Distal Diameter: 19.5mm; Catalog #651-07-195; component of the ENCORE Hip System;
    Single Use, Sterile; Recall # Z-1064-2007;
c) ALFA’ II Modular Femoral Revision Stem Porous Coated (Bowed); Size 6 Left;
    Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180L; component of the
    ENCORE Hip System; Single Use, Sterile; Recall # Z-1065-2007;
d) ALFA’ II Modular Femoral Revision Stem Porous Coated (Bowed); Size 6 Right;
    Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180R; component of the
    ENCORE Hip System; Single Use, Sterile; Recall # Z-1066-2007
CODE
a) Lot #Y031E;
b) Lot #Y032E and 2770;
c) Lot #Y131E and 2475;
d) Lot #Y132E and 1830A
RECALLING FIRM/MANUFACTURER
Encore Medical, Lp, Austin, TX, by letters on April 14, 2007. Firm initiated recall is complete
REASON
Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
CT, KS and MO
___________________________________
PRODUCT
a) Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-10GPS.
    Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 10 mm,
    250 mm long, Recall # Z-1080-2007;
b) Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System, Catalog ref. 4-12GPS.
    Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 12mm,
    250 mm long, Recall # Z-1081-2007;
c) Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-15GPS .
    Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 15 mm,
    250 mm long, Recall # Z-1082-2007;
d) Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-23DG.
    Sterile, One Time Use, Contents 4 sets 1-guide rod, 23 mm, 250 mm long, dilating,
    Recall # Z-1083-2007;
e) Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-23DGPS .
    Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 23 mm,
    250 mm long, dilating, Recall # Z-1084-2007;
f) Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4S.
    Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, Recall # Z-1085-2007
CODE
a) Lot # 5729973-57578;
b) 5729945-574730, 5730921-596737. 5730466-587239;
c) 5729974-575784;
d) 5729944-574729, 5730453-586568;
e) 5731268-603434, 5731269-603435, 5729947-574732;
f) 5729939-574724
RECALLING FIRM/MANUFACTURER
Recalling: Synovis Surgical Innovation, Saint Paul, MN, by letter on June 19, 2007.
Manufacturer: TMX Engineering & Manufacturing Inc., Santa Ana, CA. Firm initiated recall is ongoing.
REASON
There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside.
VOLUME OF PRODUCT IN COMMERCE
63 boxes (252 units)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200), Recall # Z-1089-2007
CODE
Serial Numbers: AM07030098 AM07030097 AM07030100 AM07030099 AM07030018 AM07020155 AM07020154 AM07020152 AM07020153 AM07030010 AM07030005 AM07030013 AM07030014 AM07030015 AM07030012 AM07030006 AM07030008 AM07030011 AM07030016 AM07030017 AM07030004 AM07030009 AM07030007 AM07030000 AM07030001 AM07030101 AM07030103 AM07030019 AM07020159 AM07020164 AM07020163 AM07020161 AM07020165 AM07020166 AM07020157 AM07020162 AM07020158 AM07020160 AM07020049 AM07020047 AM07020039 AM07020048 AM07020050 AM07020064 AM07030002 AM07030003 AM07030148 AM07030114 AM07020179 AM07020168 AM07020167 AM07030112 AM07020173 AM07020172 AM07020126 AM07030109 AM07020169
RECALLING FIRM/MANUFACTURER
Smiths Medical PM, Inc., Waukesha, WI, by a Safety Action Bulletin on June 5, 2007. Firm initiated recall is ongoing.
REASON
Turn off unexpectedly/ Not turn on : monitors turned off unexpectedly sounding the critical failure alarm. Advisor Vital Signs monitors that were off, would not turn back on.
VOLUME OF PRODUCT IN COMMERCE
57 units
DISTRIBUTION
Internationally
___________________________________
PRODUCT
Medtronic Performer CPB-Universal R2100375. Catalog Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures, Recall # Z-1090-2007
CODE
115, 118, 124, 138, 140, 141, 148, 113, 116, 117, 122,127, 130, 137 103, 109, 132, 135, 105, 107, 108, 110, 131, 133
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Perfusion Systems, Brooklyn Park, MN, by letters dated June 4, 2007. 
Manufacturer: RanD S.r.l., Medolla, MO Italy. Firm initiated recall is ongoing.
REASON
Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB))
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
PA, ND, MN, CA, AL, CO, MI, NY, AZ, OH Sweden, Iceland, Latvia, Germany, Italy, Austria, Belgium, France.
___________________________________
PRODUCT
a) Architect Ausab Reagent list number 1L82-25 has the following components:
    1) Architect Ausab microparticles and
    2) Architect Ausab Conjugate. in vitro diagnostic, Recall #  Z-1096-2007;
b) Architect Ausab Calibrators IVD - list number 1L82-01 has six (6) bottles with the
    following components: 1) Calibrator A and 2) Calibrators B thru F. in vitro diagnostic,
    Recall # Z-1097-2007;
c) Architect Ausab Controls list number 1L82-10 have two bottles with the following components:
    1) Negative Control and 2) Positive Control. in vitro diagnostic, Recall # Z-1098-2007
CODE
a) Lot numbers = 48453Q100 Exp date 03/23/2008, 46687Q100 Exp date 05/01/2007,
    44801Q100 Exp date 02/28/2007, 42577Q100 Exp date 12/05/2006, and
    43270Q100 Exp date 01/06/2007;
b) Lots # 50337Q100 Exp Date 08/21/2007, 48265Q100 Exp Date 06/13/2007,
    45555Q100 Exp Date 03/14/2007, 44594Q100 Exp date 02/28/2007, and
    42585Q100 Exp Date 01/01/2007;
c) Lots # 48253Q101 Exp Date 09/26/2007, 48253Q100Exp Date 06/19/2007,
    45556Q100 Exp Date 03/14/2007, 45557Q100 Exp Date 01/01/2007,
    44595Q100 Exp Date 02/28/2007, and 42586Q100 Exp Date 01/01/2007
RECALLING FIRM/MANUFACTURER
Abbott Diagnostic International, Ltd., Barceloneta, PR, by letter starting May 14, 2007. Firm initiated recall is ongoing.
REASON
During an internal study, the Architect AUSAB assay was found to read preparations of the WHO standard up to 53% higher than the WHO assigned value. This has the potential to cause elevated results and may impact the interpretation for a small percentage of results with grayzone or low-level reactive concentrations and higher proficiency sample results.
VOLUME OF PRODUCT IN COMMERCE
2134 units
DISTRIBUTION
Nationwide and Puerto Rico
___________________________________
PRODUCT
Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60, Recall # Z-1099-2007
CODE
Serial numbers: DO6E0133, DO6E253, DO6E173, DO6E233, DO6E223, DO6E383, DO6G0093, DO6E0043, and DO6E0013
RECALLING FIRM/MANUFACTURER
 Power Medical Interventions, Inc., Langhome, PA, by telephone on May 14, 2007.
REASON
Malfunction. Improper staple formation.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
DC, FL, GA, NY, and Germany
___________________________________
PRODUCT
a) Sunnex Celestial Star MR-16 (lamp holder) Medical Examination Lighting used in
    Model Numbers: CS2050C (ceiling mount), CS2050W (wall mount).
    CS2050D (dual mount) , CS2050M (mobile), Recall # Z-1100-2007;
b) Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in the following:
    Model Numbers: TS2015W (wall mount), TS2015M (mobile) , TS2015W (wall mount) ,
    TS2035M (mobile), Recall # Z-1101-2007
CODE
Units manufactured between May 15, 2006 through October 1, 2006
RECALLING FIRM/MANUFACTURER
Sunnex, Inc., Natick, MA, by letter on March 9, 2007. Firm initiated recall is ongoing.
REASON
Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.
VOLUME OF PRODUCT IN COMMERCE
376 lamps
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc.
    IMUCLONE® aPL IgM ELISA Kit, Product #649M; Recall # Z-1103-2007;
b) american diagnostica inc. IgG Conjugate, 15mL; component of the american diagnostica, inc.
    IMUCLONE® aPL IgG ELISA Kit, Product #649G, Recall # Z-1104-2007
CODE
a) Lot # 040531;
b) Lot # 040414
RECALLING FIRM/MANUFACTURER
Louisville APL Diagnostics, Inc., Seabrook, TX, by telephone on August 10, 2004. Firm initiated recall is complete.
REASON
Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.
VOLUME OF PRODUCT IN COMMERCE
80 kits
DISTRIBUTION
CT
___________________________________
PRODUCT
Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Recall # Z-1110-2007
CODE
Lot #: 7192800
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Perfusion Systems, Brooklyn Park, MN, by visit on April 18, 2007 and by letter on April 24, 2007.
Manufacturer: Medtronic Mexico, S. De R. L. De C. V., Tijuana, Baja California, Mexico. Firm initiated recall is complete.
REASON
Pyrogen Levels detected above specification: The product contains a pyrogen level above Medtronic's internal specifications while the product is labeled as nonpyrogenic.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ThromCat Thrombectomy Catheter System. Catalog number 63000-01, Recall # Z-1115-2007
CODE
Lot #: 57292, exp March 2008
RECALLING FIRM/MANUFACTURER
 Kensey Nash Corp., Exton, PA, by voice mail on May 21, 2007. Firm initiated recall is complete.
REASON
Defective Component (power supply).
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
FL, MO, NJ, and TX
___________________________________
PRODUCT
Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per carton, Recall # Z-1116-2007
CODE
Catalog numbers 604028: Lot numbers 60759210 exp 6/07, 60774338 exp 9/07, 60774339 exp 6/07, 60789198 exp 7/07, 60793228 exp 8/07, 60798079 exp 6/07, 60798080 exp 7/07, 60798858 exp 8/07, 60805581 exp 8/07, 60814631 exp 10/07, 60814632 exp 9/07, 60816722 exp 10/07, 60873702 exp 7/08, 60885381 exp 10/08, 60887358 exp 9/08, 60894377 exp 11/08, 60899729 exp 11/08, 60906657 exp 12/08, 60911647 exp 1/09, and 60916540 exp 3/09. Catalog numbers 604165: Lot numbers 60781356 exp 7/07 and 60798862 exp 10/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letter on June 5, 2007.
Manufacturer: B. Braun Medical, Inc., Cherry Hill, NJ. Firm initiated recall is ongoing.
REASON
Cracks at the Catheter Tip.
VOLUME OF PRODUCT IN COMMERCE
4,695 units
DISTRIBUTION
Japan
___________________________________
PRODUCT
a) Liko Universal Sling Bar 450 Quick Release Hook (QRH) Product Number: 3156085,
    Used with Liko patient lifts, Recall # Z-1117-2007;
b) Liko Universal Sling Bar 450 R2R Product Number: 3156095, Used with Liko patient lifts,
    Recall # Z-1118-2007
CODE
Serial numbers: 1200101 through 1201281
RECALLING FIRM/MANUFACTURER
Recalling Firm: Liko Inc., Franklin, MA, by letter on June 13, 2007.
Manufacturer: Liko AB, Lulea, Sweden. Firm initiated recall is ongoing.
REASON
Sling bar may have a center bolt break at the adapter while in use.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Biomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812, FX3814, FX4308, FX4310, FX4312, FX4314, FX4808, FX4810, FX4812, FX4814, FX4814W, Endosseous Dental Implant, Recall # Z-1119-2007
CODE
Lot numbers: All distributed product regardless of lot numbers
RECALLING FIRM/MANUFACTURER
Biomedicare, Inc., Cypress, CA, by telephone and letters on June 30, 2007. Firm initiated recall is ongoing.
REASON
Lack of validation for sterilization cycle: This recall was initiated because the validation of the sterilization process for these devices has not been completed. As a result, Biomedicare cannot assure the sterility of fixtures distributed to date.
VOLUME OF PRODUCT IN COMMERCE
8,844 units
DISTRIBUTION
AZ, CA, IL, TX, WA, and Turkey

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III

__________________________________
PRODUCT
SPI EASY Abutment. Endosseous dental implant abutment,
#4_03_700 Batch 8007 REF: 1.03.700, Recall # Z-1086-2007
CODE
Lot #: 5121
RECALLING FIRM/MANUFACTURER
Thommen Medical, AG, Waldenburg, Switzerland, by telephone and letter on May 14, 2007. Firm initiated recall is ongoing.
REASON
The undercut on the SPI EASY abutments which engages the stabilization ring of the implant is missing. Although the abutments can still be placed on the implant by the user the parts do not fulfill the quality expectations of the firm.
VOLUME OF PRODUCT IN COMMERCE
83 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) ABL 700 Series blood gas analyzers equipped with Software Version 3.833, Recall # Z-1094-2007;
b) ABL 800 FLEX series blood gas analyzers containing software version 5.24, Recall # Z-1095-2007;
CODE
a) All serial numbers of the ABL 700 series containing software version 3.833;
b) ABL 800 FLEX series blood gas analyzers containing software version 5.24
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake, OH, by Safety Alert Notice on November 13, 2006.
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
REASON
Software anomaly. Protein removing program incorporated in the operating software for Versions: V3.833 and V5.24, of the ABL700 and ABL800 Blood Gas Analyzers, may allow for protein build up on the electrode membranes of blood gas analyzers. This condition can influence analyzer results. When the protein removal program is run too frequently, more than once a week, or when running the protein removal program instead of the cleaning program, this may damage the reference membrane and result in incorrect pH and electrolyte values being reported.
VOLUME OF PRODUCT IN COMMERCE
a) 17 in US;
b) 464 US and Canada
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Cell Search Circulating Tumor Cell Kit (Epithelial) Veridex LLC,
Ref 7900001, Ref 7900000, Recall # Z-1102-2007
CODE
Lot 0036 and Lot 0036A - This is a research use only lot and not for in vitro diagnostic use.
RECALLING FIRM/MANUFACTURER
Veridex, LLC, Warren, NJ, by letter on May 24, June 1, 2007 and June 12, 2007. Firm initiated recall is ongoing.  
REASON
An increased incidence of aggregates was observed in Lot 0036 and 0036A. The presence of aggregates will cause customers to invalidate patient results.
VOLUME OF PRODUCT IN COMMERCE
490 kits
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  VETERINARY MEDICINE - CLASS I

__________________________________
PRODUCT
Ol' Roy Complete Nutrition Dry Dog Food, 55 pound bonus bags, labeled in part, Marketed by Wal-Mart Stores, Inc.,  UPC 605388720764, Recall # V-046-2007
CODE
Lot 04 0735 1, Best by Apr 13 '08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mars Petcare USA, Brentwood, TN, by press release on June 6, 2007. 
Manufacturer: Doane Pet Care Company, Manassas, VA. Firm initiated recall is ongoing.
REASON
Pet food may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1176 bags/55lb 64680 lbs total
DISTRIBUTION
VA, OH, WV, MD, PA, and NC 

END OF ENFORCEMENT REPORT FOR AUGUST 1, 2007

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