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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Blood Center of Central Iowa (The) Class II Terminated IA Details
Biologics Community Blood Center of the Ozarks Class II,Class III Terminated MO and Austria Details
Biologics New York Blood Center, Inc. Class II,Class III Terminated New Jersey, California, New York, Switzerland Details
Biologics American National Red Cross Class II Terminated California Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Biologics Community Blood Center of the Ozarks Class II Terminated AR Details
Biologics Siouxland Community Blood Bank Class II Terminated IA, SC Details
Biologics American Red Cross Blood Services Class II Terminated Missouri Details
Biologics LifeServe Blood Center Class III Terminated NC; Switzerland Details
Biologics The Blood Alliance, Inc. Class II Terminated Florida Details
Biologics LifeServe Blood Center Class II Terminated Iowa Details
Biologics Community Blood Center Of Gtr KC Class II Terminated KS, MO, IN, Austria Details
Biologics LifeServe Blood Center Class II Terminated Switzerland Details
Biologics LifeServe Blood Center Class II Terminated Iowa Details
Biologics Puget Sound Blood Center Class II Terminated Washington. Details
Biologics Florida's Blood Centers, Inc. Class II Terminated Florida Details
Biologics American National Red Cross (The) Class II,Class III Terminated NE Details
Biologics American National Red Cross (The) Class II Terminated New York Details
Biologics Lane Memorial Blood Bank Class II Terminated Oregon. Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated NC Details
Biologics Talecris Plasma Resources, Inc. Class III Terminated NC Details
Biologics Biomat USA, Inc. Class II Terminated Spain, California. Details
Biologics Talecris Plasma Resources, Inc. Class III Terminated NC Details
Drugs Body Basics Inc Class I Completed Nationwide Details
Food Brand New Energy, LLC Class I Terminated ID, NY, KS, CO, Details
Drugs Hospira Inc. Class I Ongoing Nationwide Details
Drugs The Menz Club, LLC Class I Ongoing Utah Details
Drugs Teva Pharmaceuticals USA, Inc. Class II Ongoing Nationwide Details
Devices Integra LifeSciences Corp. Class II Ongoing Distributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD. Details
Devices Abbott Laboratories, Inc Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally to Internationally distributed to Argentina, Australia, Austria, Bahamas, Brunei, Canada, Chile, Curacao, Denmark, France, Germany, Greece, Ireland, Italy, Lebanon, Mexico, Netherlands, Norway, Oman, Paraguay, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, South Korea, Spain, Switzerland, Turkey, and United Kingdom. Details
Biologics Hoxworth Blood Center UC Medical Center Class II Terminated OH Details
Biologics BloodCenter of Wisconsin, Inc Class II Terminated WI Details
Biologics Kapiolani Medical Center for Women and Children Class III Terminated Hawaii Details
Food Miami Growers Inc. Class II Ongoing NY, NJ, and PA Details
Biologics Community Blood Centers of Florida, Inc. Class II Terminated Michigan; Florida Details
Biologics Bergen Comm Reg Blood Center Class III Terminated New Jersey Details
Biologics American National Red Cross (the) Class II,Class III Terminated South Carolina; California Details
Biologics Meek Blood Center Class III Terminated Texas Details
Biologics Coffee Memorial Blood Center Class II Terminated Tennessee; Korea, Republic Of(South) Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Missouri Details
Drugs Hospira Inc. Class I Ongoing Nationwide Details
Devices Edwards Lifesciences, LLC Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, HI, ID, IN, KS, KY, LA, MA, MI, MN, MO, NC, ND, NM, NV, NY, OH, OK, PA, SD, TN, TX, VA, WA, and WI and country of: Europe. Details
Devices Stryker Howmedica Osteonics Corp. Class I Ongoing USA Nationwide Distribution Details
Drugs Lupin Pharmaceuticals Inc. Class III Ongoing Nationwide Details
Devices Endogastric Solutions Inc Class II Ongoing Nationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA, Details
Food L. K. Bowman, Incorporated Class II Ongoing Product was distributed to one firm in Utah, USA. Details
Devices Roche Diagnostics Operations, Inc. Class II Ongoing Nationwide Distribution. Details
Devices Lifescan Inc Class II Ongoing Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, 10, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NO, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SO, TN, TX, UT, VA, VI, VT, WA, WI,WV, and WY, and the countries of Russia and Ukraine. Details
Devices Bacterin International, Inc. Class II Ongoing USA Nationwide Distribution Details
Devices Nipro Diagnostics, Inc. Class II Completed Nationwide Distribution only in NY. Details
Devices Elana, Inc. Class II Ongoing Distributed in the states of Pennsylvania, Texas, and New York. Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution - (USA) Nationwide Distribution including the states of AL, AR, AZ, CA, FL, GA, IA, IN, LA, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI & WV. and the countries of Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Monaco, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand & United Kingdom Details
Devices Instrumentation Industries Inc Class II Ongoing Worldwide Distribution - USA including AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. Shipped internationally to Canada, Ireland, Hong Kong, the Netherlands, New Zealand, and Thailand. Details
Food La Preferida Inc Class II Ongoing Nationwide (AL, CA, CO, FL, GA, IA, IL, IN, MA, MI, MN, MO, NE, OH, PA, TN, TX, and WI) Details
Devices Ortho-Clinical Diagnostics Class II Ongoing Worldwide Distribution- USA (nationwide) including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Republic of Panama, Singapore, Spain, and Venezuela. Details
Devices Siemens Healthcare Diagnostics, Inc. Class II Ongoing Distributed within the US to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Details
Devices Siemens Healthcare Diagnostics, Inc Class II Ongoing Nationwide Distribution. Details
Devices Lifescan Inc Class I Ongoing USA Nationwide Distribution Details
Food Zumbro River Brand, Inc Class II Ongoing VT and Canada Details
Biologics BD Biosciences, Systems & Reagents Class III Ongoing CA, GA, NC, NY, PA, OR, TX, OK, MO, VA, MI, NJ, CT, UT and to Australia, Canada, Belgium, China, India, South Korea, Taiwan. Details
Devices Maquet Cardiovascular, LLC Class II Ongoing Worldwide Distribution - USA Nationwide and the following countries: Australia, Austria, Belarus, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Iceland, Iran, Ireland, Italy, Jordan, Kazakhstan, Korea, Kuwait, Luxembourg, The Netherlands, Norway, Oman, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and the United Kingdom. Details
Devices Synvasive Technology Inc Class II Ongoing USA Distribution in the state of IN Details
Devices Carefusion Corporation Class II Ongoing Worldwide Distribution USA Nationwide and the countries of Australia and Canada. Details
Devices Smith & Nephew Inc Class II Ongoing Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO. Details
Devices Alere San Diego, Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of Canada, South Africa, Netherlands, Italy, Brazil, Singapore, Russia, Hong Kong, Argentina, South Korea, Philippines, El Salvador, Indonesia, and Trinidad. Details
Drugs Precision Dose Inc. Class II Ongoing Nationwide and Puerto Rico Details
Devices Biomet U.K., Ltd. Class II Ongoing Worldwide Distribution - USA (nationwide), Europe, Japan, Australia, Canada, Singapore, South Africa, and Costa Rica. Details
Devices Vital Images, Inc. Class II Ongoing Worldwide Distribution - USA including AL, AR, CA, CO, IA, MI,MN, MO, NY, NC, OH, OR, PA, TX, and UT. Internationally to AUSTRIA, BELGIUM, CANADA, CHINA, COLOMBIA, GEORGIA, JAPAN, KOREA, MACEDONIA, NETHERLANDS, POLAND, PORTUGAL, RUSSIAN FEDERATION, SINGAPORE, SWEDEN, SWITZERLAND, TURKEY, UKRAINE, UNITED KINGDOM. Details
Devices Toshiba American Medical Systems Inc Class II Ongoing Nationwide Distribution. Details
Devices Sr Instruments Inc Class II Ongoing USA Distribution in the state of Texas. Details
Devices Advanced Sterilization Products Class II Ongoing Nationwide Distribution-USA including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI. Details
Devices Philips Healthcare Inc. Class II Ongoing Worldwide Distribution including USA (nationwide) Details
Devices Accuray Incorporated Class II Ongoing Worldwide distribution, including Nationwide in the US and the countries of Korea, Myanmar, Canada, Belgium, England, Czech Republic, Finland, France, Germany, Greece, India, Italy, Poland, Russia, Spain, Switzerland, Turkey, Columbia, Mexico, Japan and Saudi Arabia. Details
Devices Horiba Instruments, Inc dba Horiba Medical Class II Ongoing Nationwide Distribution. Details
Devices Carefusion Corporation Class I Ongoing Worldwide Distribution - USA (nationwide) and the countries of Australia and China. Details
Devices DeGotzen Class II Ongoing US (nationwide) Details
Food Nestle Puerto Rico Inc Class III Ongoing Product was distributed in Puerto Rico only (wholesalers and distributors). Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing Worldwide Distribution - USA including the states of AL, CA, CO, DC, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WI, WV, and WY. and the countries of Canada and Australia. Details
Food Publix Super Markets, Inc. Class I Ongoing AL, FL, GA, SC, and TN Details
Devices Edwards Lifesciences, LLC Class II Ongoing Nationwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI. Details
Devices GE Healthcare, LLC Class II Completed Worldwide Distribution -- USA, including all states except ME, and the U.S. Virgin Islands; and, the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MALAYSIA, NETHERLAND, NEW ZEALAND, NORWAY, PHILIPPINES,S QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM. Details
Devices Intuitive Surgical, Inc. Class II Ongoing Worldwide Distribution.-USA (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom. Details
Devices Transonic Systems Inc Class II Ongoing Worldwide Distribution - USA Nationwide including the states of AZ, CA, FL, GA, NM, NY, TX, VA and WA and countries of Netherlands, Canada and Russia. Details
Veterinary Wilbur Ellis Co Class III Ongoing Distributed in Oregon Details
Devices Advanced Sterilization Products Class II Ongoing Nationwide Distribution Details
Devices Edwards Lifesciences, LLC Class II Ongoing USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX. Details
Devices Alere San Diego, Inc. Class III Ongoing Nationwide Distribution including TN, WA, UT, KS, KY, MN, GA, MA, PA, NY, VT, and the Dist. of Columbia Details
Food DPI Specialty Foods West, Inc. Class III Ongoing Distributed within the state of California. Details
Food Tristar Food Wholesale Co Inc Class II Ongoing New York Details
Devices Synvasive Technology Inc Class II Ongoing Worldwide Distribution - USA (nationwide) and countries of: Austria, Australia, Belgium, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Panama, Spain, Sweden, Switzerland, Tunisia, United Kingdom and Yemen. Details
Drugs Pfizer Inc. Class II Ongoing Nationwide and PR Details
Food Little Mermaid Smokehouse Class I Ongoing California. Details
Devices Acist Medical Systems Class II Ongoing Nationwide Distribution including the states of AL, AK, AZ, AR, CA, CO, CT, DC, GA, HI, ID, IL, IN, IA, KS, KY, MD,MI, MN, MS, MO, NV, NH, NJ, NM, NY,NC, OR, OK, OH, PA, TN, TX, VA and WA. Details
Devices Hospira Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia. Details
Drugs Actavis South Atlantic LLC Class III Ongoing Nationwide Details
Devices Heritage Labs International LLC Class II Ongoing Nationwide Distribution including the states of AL, CA, GA, IL, IN, KY, MA, MD, NC, NY, OK and VA. Details
Devices GE Healthcare, LLC Class II Completed Worldwide Distribution - Nationwide Distribution including the states of FL, IL, IN, LA, MI, MN, NJ, NM, NY, OH, PR, SC, TX and VA and the countries of Vietnam, Latvia, Italy, Israel, Indonesia, Hong Kong, United Kingdom, Finland, Spain, Czech Republic, Canada, Bahrain and Australia. Details
Food Two Chefs On A Roll, Inc Class II Ongoing CA, WA, AZ, IL, PA Details
Devices GE Healthcare, LLC Class II Completed Worldwide Distribution - USA Nationwide including the states of: AK, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, LA, MD, MI, ,N, ,S, MO, MT, NJ, NM, NY, NC, OH, OK, PA, SC, SD, TN,TX, UT, VA, WA, WI. and the countries of : AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA, BRAZIL, CANADA, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KOREA, LIBYA, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, POLAND, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY and UNITED ARAB EMIRATES. Details
Food Fresh And Easy Class II Ongoing CA, AZ, NV Details
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