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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics One Lambda Inc Class III Ongoing US states nationwide. International: Canada, U.A.E, Saudi Arabia, Cyprus, UK, France, Germany, Greece, Israel, Italy, S.Africa, Jordan, Kuwait, Lebanon, Poland, Serbia, Croatia, Seria, Montenegro, Austria, Netherlands, Russia, Finland, Spain & Portugal, Turkey, Russia, Finland, Brazil, Argentina, Australia, Qatar, Bangladesh, Korea, China, Chile, Bolivia, Paraguay, Costa Rica, Ecuador, Guatemala, India, Japan, Mexico, Malaysia, New Zealand, Peru Philippines, Pakistan. Details
Biologics American Red Cross Blood Services Class II Terminated Nebraska; Pennsylvania;California Details
Biologics American National Red Cross Class II Terminated Canada. Details
Biologics American Red Cross Blood Services Class II Terminated MO, IL, AL, SC, MI, PR, France Details
Biologics The American National Red Cross South Carolina Region Class II Terminated South Carolina, California Details
Biologics Cangene Corporation - Rh Plasma Center Class II Terminated Canada Details
Biologics Florida's Blood Centers, Inc. Class II Terminated Florida Details
Biologics BioLife Plasma Services L.P. Class II Terminated Austria Details
Biologics Florida Blood Services, Inc. Class II Terminated Florida, Switzerland. Details
Biologics Upstate New York Transplant Services Class III Terminated New York and New Jersey Details
Biologics Florida's Blood Centers, Inc. Class II Terminated Austria. Details
Biologics Florida's Blood Centers, Inc. Class II Terminated Austria Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated North Carolina Details
Devices Spinal Elements, Inc Class III Terminated Distributed in OH and PA. Details
Devices Karl Storz Endoscopy America Inc Class II Terminated Nationwide distribution: USA including states of: IL, CA, WV, TX, SC, WI, NY, PA, NE, NJ, MD, OH, IA, and NC. Details
Biologics American National Red Cross, Penn-Jersey Region Class II Terminated Pennsylvania Details
Biologics South Bend Medical Foundation, Inc. Class II Terminated Indiana Details
Biologics Puget Sound Blood Center and Program Class II Terminated Austria Details
Biologics Talecris Plasma Resources Inc Class II Terminated North Carolina Details
Biologics The Children's Hospital Assoc. Transfusion Medicine Services Class II Terminated Colorado Details
Biologics Mid-South Regional Blood Center Class II Terminated Tennessee Details
Biologics Hemacare Corporation Class II Terminated California Details
Biologics Community Blood Center Of Gtr KC Class III Terminated Missouri Details
Biologics Blood Assurance Inc Class II Terminated Tennessee Details
Biologics Lane Memorial Blood Bank Class II Terminated Oregon Details
Biologics Blood Assurance Inc Class II Terminated Tennessee Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated North Carolina Details
Biologics Bio-Blood Components, Inc. Class III Terminated Tennessee Details
Biologics Blood Systems, Inc. dba United Blood Services Class III Terminated Texas Details
Devices Becton Dickinson & Co. Class II Ongoing Distributed in the states of CA, FL, GA, NJ, and TX. Details
Veterinary Procter & Gamble Co Class III Ongoing Product was shipped to the following states: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MI, MN, MO, NC, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA & WI. Product was also shipped to Canada. Details
Biologics International Biologics LLC Class III Terminated Nevada; Ohio; Texas Details
Devices Stryker Endoscopy Class II Ongoing Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China. Details
Devices Baxter Healthcare Corp. Class II Ongoing Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia. Details
Devices Siemens Healthcare Diagnostics, Inc. Class II Ongoing US Nationwide Distribution including Puerto Rico. Details
Devices Smiths Medical ASD, Inc. Class II Ongoing Worldwide distribution: USA (Nationwide) and countries of: Arab Emirates (AE) Ireland (IE), Albania, Israel (IL), Argentina (AR),Italy (IT) Armenia (AM) , Japan (JP), Austria (AT) Jordan (JO), Bahrain (BH) Kuwait (KW) Belgium (BE), Lebanon (LB), Belarus , Netherlands (NL), Brazil (BR),Nigeria (NG), Bulgaria (BG) , Pakistan (PK), Canada (CA) Poland (PL), China (CN) Romania (RO), Columbia (CO), Russia (RU), Cyprus(CY) , Saudi Arabia (SA) Czech (CZ) , Singapore (SG), Denmark (OK), South Korea (KR), Egypt (EG), Spain (ES), Finland (FI), Sri Lanka (LK),Germany (DE) Turkey (TR) Ghana (GH) , Uganda (UG), Great Britain (GB) Ukraine (UA), Greece (GR) Uruguay (UY), and Hong Kong (HK). Details
Drugs L. Perrigo Co. Class III Ongoing Nationwide Details
Devices Cardinal Health, Medical Products & Services Class I Ongoing Distributed in the states of AR, MS, SC, and TN. Details
Biologics Ortho Clinical Diagnostics Inc Class III Terminated Multiple U.S. States Details
Biologics North Carolina Eye Bank, Inc. (The) Class II Terminated Texas Details
Devices Synthes USA HQ, Inc. Class II Ongoing Nationwide Distribution: USA including states of: IL, IN, MA, MI, MO, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WI Details
Biologics Siemens Healthcare Diagnostics Inc. Class II Ongoing US and Belgium, France, Greece, Italy, Portugal, Spain, Germany, Kenya, Martinique, Austria, Brazil, Canada, Czech Republic, Guadeloupe, Ireland, Israel, Kuwait, Latvia, Mexico, Panama, Peru, Saudi Arabia, Thailand, UK, Uruguay, Vietnam Details
Biologics University Of Miami Miller School of Medicine Tissue Bank Class III Terminated Wisconsin; Florida Details
Biologics The American National Red Cross - Southern Region Class II Terminated Georgia Details
Devices Abbott Diabetes Care, Inc. Class I Ongoing Nationwide Distribution Details
Devices Cypress Medical Products LLC Class II Ongoing US Distribution to the state of VA only. Details
Devices DePuy Mitek, Inc., a Johnson & Johnson Co. Class II Ongoing Worldwide Distribution - USA including KY, NJ and Internationally to Argnetina, Australia, Belgium,Columbia, India, France, Japan, Jordan, Latvija, Israel, Korea, and Great Britain. For questions regarding this recall call 508-977-3813. Details
Veterinary Lloyd Inc. of Iowa Class III Ongoing Distribution was made nationwide, including Puerto Rico, Guatemala and Israel. Specific distribution will be reported. Details
Devices Olympus America Inc. Class II Ongoing Nationwide Distribution - USA Nationwide including the states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, and WY. Details
Devices Symmetry Medical/SSI Class II Ongoing Worldwide Distribution - USA including CA, MS, FL, PA, TN, CO, IL, TX, OH, MI, MA, IL and internationally to Belgium, Canada, Germany, UK Details
Devices Medshape Solutions, INC. Class II Ongoing Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI. Details
Drugs Physicians Total Care, Inc. Class III Completed NC Details
Food Maple View Ice Cream Class I,Class II Ongoing NC Details
Food Winn-Dixie Logistics, Inc. Class II Ongoing AL, GA, FL, MS, and LA Details
Drugs Hospira Inc. Class II Ongoing Nationwide and Puerto Rico Details
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