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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics American National Red Cross (The) Class II Terminated Nationwide (including MO, IL, PR, AR, SC, GA, TN, MI, AL, OK, TX) Details
Biologics BioLife Plasma Services L.P. Class II Terminated Austria Details
Biologics ZLB Bioplasma, Inc. Class II Terminated IL, Switzerland Details
Biologics American National Red Cross (The) Class II Terminated NY Details
Biologics Lane Memorial Blood Bank Class III Terminated OR Details
Biologics New York Blood Center, Inc. Class III Terminated New York Details
Biologics DCI Biologicals Little Rock LLC Class II Terminated United Kingdom Details
Biologics American Red Cross Blood Services Class II Terminated Iowa, Nebraska Details
Biologics American National Red Cross (The) Class II Terminated California Details
Biologics Florida's Blood Centers, Inc. Class III Terminated Florida Details
Biologics Florida's Blood Centers, Inc. Class II Terminated Florida Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated North Carolina Details
Biologics Mercy Hospital St Louis Class III Terminated Missouri Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated Florida Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated Florida Details
Biologics Florida Blood Services, Inc. Class II Terminated Florida Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated North Carolina Details
Biologics Florida's Blood Centers, Inc. Class II Terminated Austria Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated North Carolina Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated North Carolina Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated North Carolina Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated North Carolina Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated NC Details
Biologics BioLife Plasma Services L.P. Class II Terminated California, Austria Details
Biologics Continental Services Group, Inc. Class II Terminated Florida Details
Biologics Continental Services Group, Inc. Class II Terminated Switzerland Details
Biologics American National Red Cross (The) Class II Completed OK, CA, TX, IN Details
Biologics Blood Systems, Inc. Class II Terminated TX Details
Biologics United States Blood Bank, Inc. Class II Terminated Florida Details
Biologics Octapharma Plasma Inc Class III Terminated California Details
Biologics Octapharma Plasma, Inc. Class III Terminated CA, Switzerland Details
Biologics Octapharma Plasma, Inc. Class II Terminated California Details
Biologics The Blood Alliance, Inc. Class II Terminated Florida, Georgia, South Carolina Details
Drugs Brower Enterprises Inc Class I Ongoing Nationwide and Puerto Rico (through the internet). Details
Biologics Blood Assurance Inc Class II Terminated TN and IN Details
Biologics The American National Red Cross - Southern Region Class III Terminated GA Details
Biologics LifeShare Blood Centers Class II Terminated TX Details
Biologics Blood Centers of the Pacific - Irwin Center Class III Terminated CA Details
Devices Sirtex Medical Limited Class III Completed Nationwide Distribution-USA (nationwide) including DC and the states of AZ, CA, CT, GA, ID, IL,KY, LA, MD, ME, MO, MT, NJ, NV, WA, and WV. Details
Biologics Micro Typing Systems, Inc. Class II,Class III Ongoing Canada; Multiple U.S. States Details
Devices Spinal Solutions, LLC Class II Ongoing Nationwide Distribution including NV, WI, MD,and CA. Details
Devices Orthopedic Alliance LLC Class II Ongoing Distributed in Texas. Details
Devices Stellate Systems Class II Terminated Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CT, DE, FL, HI, IA, IN, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NJ, NY, OH, OR, PA, RI, SC, TX, VA, VT, WI, WV, and WY; and the countries of: Argentina, Australia, Bahrain, Brasil, Canada, China, Denmark, Finland, France, Germany, Greece, Haiti, Hong Kong, Hungary, Indonesia, Iran, Israel, Italy, Japan, Korea, KSA, Mexico, Netherlands, Norway, Pakistan, Portugal, Rep. DE Panama, Saudi Arabia, Spain, Switzerland, Taiwan ROC, Thailand, Turkey, and United Kingdom. Details
Food Ozone Confection & Bakers Supply Co. Class II Ongoing Florida, New Jersey, Pennsylvania, Massachusets and New Hampshire and Maryland. Details
Devices Nova Biomedical Corporation Class II Ongoing Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy. Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution - US, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, IL, IN, IA, KY, LA, ME, MD, MA, MI, ,N,MS, MO, NE, NV, NH, NJ, NM, NY,NC, OH, OK,OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI and the countries of TAIWAN, TURKEY, SINGAPORE, SWD EN, PORTUGAL, POLAND, NEW ZEALAND, NORWAY, NETHERLANDS, MALAYSIA, MEXICO, SOUTH KOREA, JAPAN, ITALY, INDIA, ISRAEL GREAT BRITAIN, FRANCE, DENMARK, GERMANY, SWITZERLAND, CANADA, BRAZIL BELGIUM, AUSTRALIA, and ARGENTINA. Details
Devices Alere San Diego, Inc. Class II Ongoing USA Nationawide Distribution Details
Devices DePuy Mitek, Inc., a Johnson & Johnson Co. Class II Ongoing Nationwide Distribution. Details
Devices Ortho-Clinical Diagnostics Class II Ongoing Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela. Details
Devices Teleflex Medical Class II Ongoing Worldwide Distribution - USA and the countries of Singapore, Canada, New Zealand, Germany, Ireland, Japan and Australia. Details
Devices Beckman Coulter Inc. Class II Ongoing Worldwide Distribution - USA, including Canada and Puerto Rico and the states of NJ, TX, CA, UT, KS, MA, NY, MI, GA, VA, IN, WI, IL, OH, NV, NC and PA. and the countries of Australia, Belgium, Czech Republic, Japan, Germany, Brazil, China, Italy, Ireland, Israel, India, Hong Kong, Malaysia, Netherlands, Spain, Switzerland, France, Taiwan, Turkey, United Kingdom and Vietnam. Details
Devices Ortho-Clinical Diagnostics Class III Ongoing Worldwide Distribution- USA (nationwided) and countries of: Australia, Brazil, Canada, Chile, Chao Yang District, Beijing, Columbia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela. Details
Food SIB, Inc. Class II Ongoing retail grocery stores in Indiana and 1 retail store in Illinois Details
Biologics BloodCenter of Wisconsin, Inc Class II Terminated Switzerland Details
Devices Philips And Neusoft Medical Systems Co., Ltd. Class II Ongoing Nationwide distribution: USA including states of: California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico. Details
Devices GE Healthcare, LLC Class II Completed Worldwide Distribution - USA including GA, and NY; and countries of: Canada, Israel, Italy and Switzerland. Details
Devices Accuray Incorporated Class II Ongoing Worldwide Distribution - USA Nationwide including the states of: OH, MO. OK, CA and VA and the countries of: Finland, France, Luxembourg, Poland, Russia, Turkey and Japan. Details
Food All One, Inc. Class II Ongoing Nationwide including: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IN, KY, KS, LA, ME, MD, MI, MO, MS, NC, NJ, NM, NE, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WY. Details
Food Planet Food Class III Ongoing TX Details
Devices Varian Medical Systems, Inc. Oncology Systems Class II Ongoing Worldwide Distribution - USA (Nationwide) and countries of: Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Mexico Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab E, and United Kingdom. Details
Food Royal Foods, Inc. Class III Terminated The two different products were distributed to two different restaurants (one for each) located in Oregon Details
Food La Espanola Meats Inc Class II Ongoing Sold through recalling firm's owned retail market in California. Details
Food Wild Blue Yonder Foods/Waugh Class I Ongoing MA, CT, NJ, PA, NC, SC, FL, MI and TX Details
Food Nexgen Pharma, Inc. Class III Ongoing Distributed to large and small retailers located nationwide as well as two foreign locations (Canada and Netherlands). Details
Food Cedarlane Natural Foods Inc/Frankly Fresh Foods Inc. Class I Ongoing CA Details
Food Jans Enterprises Corp. dba WIRA Corp. Class II Terminated Nationwide in the US Details
Drugs Mylan Pharmaceuticals Inc. Class III Ongoing Nationwide. Details
Food Meijer Distribution, Inc Class II Ongoing Meijer Distribution Centers and Retail Stores: Illinois, Indiana, Kentucky, Michigan, and Ohio Details
Drugs OPMX, LLC Class II Ongoing Nationwide Details
Drugs Sandoz Incorporated Class II Ongoing Nationwide Details
Drugs Axium Healthcare Pharmacy dba Balanced Solutions Compounding Class II Ongoing CO, GA, MI, and Puerto Rico Details
Drugs Qualitest Pharmaceuticals Class II Ongoing Nationwide Details
Drugs Hospira Inc. Class II Ongoing Nationwide and Puerto Rico Details
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