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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Devices Advanced Sterilization Products Class II Ongoing Worldwide Distribution - USA (nationwide) Details
Biologics New York Blood Center, Inc. Class III Terminated NY Details
Biologics Northern California Community Blood Bank Class II Terminated CA, NJ, OH, TN Details
Biologics American National Red Cross (The) Class II Terminated CA Details
Biologics Central Kentucky Blood Center, Inc. Class III Terminated KY Details
Biologics American National Red Cross (The) Class III Terminated CA Details
Biologics ZLB Bioplasma, Inc. Class II Terminated Illinois Details
Biologics San Antonio Eye Bank Class II Terminated CA, Saudi Arabia Details
Food Cafe Moto Class II Ongoing All direct consignees located within the state of CA. Details
Biologics Heartland Lions Eye Bank Class II Terminated Corneas were distributed to Jordan Eye Bank, Jordan University Hospital, Queen Rania Street, Amman, Jordan Details
Food Nestle USA Class III Terminated Distributed to distributor and retail in US State of TX. Details
Biologics Delta Blood Bank Class II Terminated CA. Details
Biologics Memorial Blood Centers Class II Terminated MN Details
Biologics Bacterin International Inc. Biologics Division Class III Ongoing Distributed nationwide Details
Biologics Memorial Blood Centers Class II Terminated NC, NJ, MN, WI, OH, CA, MI. Details
Devices Church & Dwight Inc Class II Ongoing Worldwide Distribution. Details
Biologics Metro Blood Services Class III Terminated New Jersey Details
Biologics Seattle Sperm Bank LLC Class II Ongoing Approximately two thirds of product went to Denmark, Australia, Canada, and Mexico. The remaining one third distributed domestically nationwide. Details
Drugs Eagle Pharmaceuticals Inc. Class I Ongoing New Jersey Details
Biologics Haemonetics Corporation Class III Terminated Nationwide Details
Devices Smiths Medical ASD, Inc. Class I Ongoing Worldwide Distribution -- USA, including the state of CA, and country of Canada. Details
Biologics International Sight Restoration, Inc. Class II Terminated Cario, Egypt Details
Food Defense Nutrition Class III Ongoing Distribution was made to IL, MI, MS, AL, CO, MD, TX, GA, NY, KS, AR, FL, NV, WA, CT, UT, VT, PA, LA, TN, NE, MN and OR. Foriegn distribution was made to Canada. Details
Veterinary Hartz Mountain Corp. Class I Ongoing Nationwide Details
Devices Integra LifeSciences Corp. Class II Ongoing Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NM, NJ, NY, NV, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA & WI and internationally to Belgium; Danemark; France; Germany; Israƫl; Italy; Lebanon; Luxemburg; Netherlands; Norway; Portugal; Saudi Arabia; Spain; Switzerland; Turkey & United Kingdom. Details
Veterinary Central Garden & Pet Company Class I Ongoing Nationwide including Puerto Rico. OUS to include: Abu Dhabi, Argentina, Australia, Brazil, Brunei, Canada, China, Costa Rica, Czechoslovakia, Dominican Republic, Dutch Antilles, Finland, Germany, Great Britain, Greece, Guam, Honduras, Hong Kong, Ireland, Israel, Japan, Korea, Kuwait, Mexico, New Zealand, Pakistan, Panama, Russia, Singapore, South Africa, Sweden, Thailand, and Trinidad. Details
Devices Zimmer Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of Singapore, China, Hong Kong,Canada, Australia, Japan, Europe, Germany, India, and Finland. Details
Biologics Arc Blood Services, New England Region Class II Terminated Connecticut; California Details
Biologics American Red Cross Blood Services Class III Terminated Connecticut; New York Details
Biologics Central California Blood Center Class II Terminated Ohio; Maryland; California; New York Details
Biologics Blood Assurance Inc Class II,Class III Terminated Tennessee; Indiana Details
Biologics LifeServe Blood Center Class II Terminated Iowa Details
Veterinary Wellpet Llc Class I Ongoing Nationwide Canada Details
Biologics Gulf Coast Regional Blood Center Class II Terminated Texas Details
Biologics Immucor Inc Class III Ongoing US/Nationwide; Canada, China, Denmark, India, Israel, Japan, Philippines, & Sweden Details
Biologics Biomat USA, Inc. Class III Terminated California Details
Drugs Mallinckrodt Inc. Class II,Class III Ongoing Nationwide Details
Biologics SCC Soft Computer Class II Ongoing New York and Michigan Details
Biologics Plasmacare Inc Class III Terminated California Details
Biologics Plasmacare Inc Class III Terminated California Details
Biologics Plasmacare Inc Class III Terminated California Details
Biologics Plasmacare Inc Class III Terminated California Details
Biologics Plasmacare Inc Class III Terminated California Details
Biologics Plasmacare Inc Class III Terminated California Details
Biologics Plasmacare Inc Class III Terminated California Details
Biologics Plasmacare Inc Class III Terminated California Details
Biologics Plasmacare Inc Class III Terminated California Details
Biologics Plasmacare Inc Class III Terminated California Details
Biologics Plasmacare Inc Class III Terminated California Details
Biologics Plasmacare Inc Class III Terminated California Details
Biologics Plasmacare Inc Class III Terminated California Details
Biologics Plasmacare Inc Class III Terminated California Details
Biologics Plasmacare Inc Class III Terminated California Details
Biologics Plasmacare Inc Class III Terminated California Details
Biologics Plasmacare Inc Class III Terminated California Details
Biologics Plasmacare Inc Class III Terminated California Details
Devices Abbott Point Of Care Inc. Class II Completed USA ( nationwide ) Details
Food J F C International Inc Class II Ongoing Nationwide in the US Details
Drugs Watson Laboratories Inc Class III Ongoing Nationwide. Details
Drugs VistaPharm, Inc. Class II Ongoing Nationwide Details
Biologics LifeSouth Community Blood Centers Inc - Birmingham Region Class II Terminated Alabama Details
Biologics LifeSouth Community Blood Centers Inc - Birmingham Region Class II Terminated Alabama Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated Florida Details
Biologics LifeShare Blood Centers Class II Terminated Texas Details
Biologics Blood Systems Inc/dba United Blood Services Class II Terminated Mississippi; Alabama Details
Devices GE OEC Medical Systems, Inc Class II Terminated Worldwide Distribution - US (nationwide) and the countries of: Canada, France, Japan, and China. Details
Food Itoen (USA) Inc Class III Ongoing Product was released for distribution in HI. Details
Devices Sunrise Medical (US) LLC Class II Ongoing Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela. Details
Food Andante Dairy Class II Ongoing CA, OH and NY to retail stores and restaurants. Details
Biologics Sunquest Information Systems, Inc. Class III Terminated Nationwide Details
Devices Stryker Instruments Div. of Stryker Corporation Class II Ongoing Worldwide Distribution - US Nationwide and the countries of England, France, Netherlands, and Switzerland. Details
Devices Perkinelmer Class II Ongoing Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland, Details
Devices Beekley Corporation Class II Ongoing US Nationwide Distribution Details
Devices Baxter Healthcare Renal Div Class II Ongoing Nationwide Distribution includingArizona, California, Ohio, Pennsylvania and Virginia. Details
Devices ICU Medical, Inc. Class II Completed Nationwide distribution Details
Devices Intuitive Surgical, Inc. Class II Ongoing Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia. Details
Devices Iris Diagnostics Class III Ongoing Nationwide Distribution Details
Food Winn Dixie Stores, Inc. Class II Completed Florida, Georgia, Alabama, Mississippi, Louisiana Details
Devices Exactech, Inc. Class II Ongoing Worldwide Distribution - USA including FL, MO, MA, AL, KY, IN, NC, LA,PA, VA, OH, NY, ME, MI, TX, KS, TN, OK, NJ, WA, CO, GA, CA, MN, IA, OR, and IL and Internationaly to Austria, Luxenbourg, Sweden, Germany, Spain, France, Greece, Italy, Nederland, United Kingdom, Canada, India, Australia, Switzerland, and Sao Palo. Details
Drugs Apotex Inc. Class II Ongoing Nationwide and Puerto Rico Details
Devices Maquet Medical Systems, Usa Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Germany, Denmark, Spain, France, Hong Kong, Ireland, Israel, India, Italy, Japan, South Korea, Netherlands, Poland, Russia, Saudi Arabia, Sweden, Singapore, and Thailand. Details
Drugs Dr. Reddy's Laboratories, Inc. Class II Ongoing Nationwide and Puerto Rico Details
Drugs Zydus Pharmaceuticals USA Inc Class II Ongoing Nationwide Details
Food The Wright Group dba Wright Enrichment, Inc. Class I Ongoing IN Details
Food Spillson's, Ltd. Class I,Class II Ongoing Retail stores, truck stops, Vending facilities in the Monroe Michigan Area. Details
Devices Aesculap Implant Systems LLC Class II Ongoing US Nationwide Distribution - including the states of CO, OH, OK and TX. Details
Drugs West-ward Pharmaceutical Corp. Class II Ongoing All lots were distributed throughout the US. Details
Drugs Axcentria Pharmaceuticals LLC Class III Ongoing Michigan Details
Drugs Cadence Pharmaceuticals Class II Ongoing Nationwide Details
Drugs Bayer HealthCare Pharmaceuticals Inc. Class II Ongoing Kansas and California. Details
Food CHETAK SAN FRANCISCO LLC. Class I Ongoing Northern CA only Details
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