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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 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 unknown Details
Biologics Blood Center of Central Iowa (The) Class III Terminated PA Details
Biologics Blood Center of Central Iowa (The) Class II Terminated IA Details
Biologics The American National Red Cross - Southern Region Class III Terminated GA Details
Biologics Blood Systems, Inc. Class II Terminated Switzerland Details
Biologics Blood Center of Central Iowa (The) Class II Terminated IA, CSL (fractionator) Details
Biologics Blood Center of Central Iowa (The) Class II Terminated IL, IA Details
Biologics American National Red Cross (The) Class II Terminated MI Details
Biologics LifeServe Blood Center Class III Terminated New Jersey Details
Biologics LifeServe Blood Center Class III Terminated Iowa Details
Biologics American National Red Cross (The) Class III Terminated California, Idaho. Details
Biologics American National Red Cross (The) Class II Terminated California. Details
Biologics American National Red Cross (The) Class II Terminated Idaho. Details
Biologics DCI Biologicals LLC Class II Terminated England Details
Biologics American Red Cross Blood Services Class III Terminated Kansas Details
Biologics LifeServe Blood Center Class II Terminated Iowa Details
Biologics American National Red Cross Class III Terminated Utah. Details
Biologics American Red Cross Blood Services Class II Terminated Kansas Details
Biologics American Red Cross Blood Services Class II Terminated Kansas Details
Biologics American National Red Cross Class II Terminated Oklahoma, Texas Details
Biologics American National Red Cross (The) Class II,Class III Terminated UT, CA Details
Biologics American National Red Cross (The) Class II Terminated NY Details
Biologics LifeServe Blood Center Class II,Class III Terminated Iowa, Michigan Details
Biologics LifeServe Blood Center Class II Terminated Iowa Details
Biologics American National Red Cross Class II,Class III Terminated California and Oregon. Details
Biologics The American National Red Cross - Southern Region Class II,Class III Terminated CA & GA Details
Biologics The American National Red Cross - Southern Region Class II,Class III Terminated CA & GA Details
Biologics American National Red Cross Class II Terminated Ohio. Details
Food Servatii Inc Class II Terminated Product was distributed to the 11 Servatii retail locations. Details
Biologics American National Red Cross Class III Terminated Washington. Details
Biologics LifeServe Blood Center Class III Terminated Iowa Details
Biologics LifeServe Blood Center Class III Terminated Iowa, Pennsylvania, Switzerland Details
Biologics New York Blood Center, Inc. Class II Terminated NY Details
Biologics Talecris Plasma Resources, Inc. Class III Terminated NC Details
Food Miravalle Food, Inc Class II Ongoing US States: CA, NV, OR, ID, WA, UT, and CO. Details
Biologics Biomat USA, Inc. Class II Terminated Spain, California. Details
Devices CareFusion Corporation Class II Terminated Worldwide Distribution - USA (Nationwide) including CANADA. Details
Biologics Blood Systems, Inc Class II,Class III Terminated CA, MT, WY, MS, CO, SD, TX, NV, AR Details
Biologics CSL Plasma, Inc. Class II Terminated Illinois, North Carolina, and France. Details
Biologics CSL Plasma, Inc Class III Terminated NC, Germany & Switzerland Details
Biologics Talecris Plasma Resources, Inc. Class III Terminated North Carolina Details
Biologics Talecris Plasma Resources, Inc. Class III Terminated NC Details
Biologics Talecris Plasma Resources, Inc Class II Terminated NC Details
Biologics DCI Biologicals LLC Class II Terminated PA; UK, Israel Details
Drugs Hospira, Inc. Class III Terminated NC Details
Devices Siemens Healthcare Diagnostics, Inc. Class III Ongoing Nationwide distribution: USA including Puerto Rico and the states of AL, OH, MO, GA, IL, CT, IA, SC, VA, TX, FL, NY, NC, CA, NM, AZ, CA, MI, NJ, PR, MS, NE, WV, PA, MT, MA, MD, KS, NH, TN, VT, LA, CO, ID, WA, NH, DE and OR. Details
Devices Smiths Medical ASD, Inc. Class II Completed Distributed in the state of NH. Details
Drugs Physicians Total Care, Inc. Class II Completed FL, NC, TX, CO, VA, SC, GA, KS, LA, MO Details
Devices Abbott Laboratories, Inc Class II Ongoing Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA. Details
Devices Cardinal Health Class II Ongoing Worldwide Distribution - USA (Nationwide) and the countries of Australia, Canada and Japan. Details
Biologics Jubilant HollisterStier, LLC Class III Terminated Multiple U.S. States; Philippines, Bermuda, India, Hong Kong, Japan, South Korea, Jamaica, Brazil Details
Drugs West-ward Pharmaceutical Corp. Class II Ongoing GA, AR Details
Devices Mindray DS USA, Inc. d.b.a. Mindray North America Class II Ongoing Distributed in the states of NC and TX. Details
Devices Synthes USA HQ, Inc. Class II Ongoing Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, KS, KY, LA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, TN, TX, VA, VT, WI, WV, and WY. Details
Food Mkg Provisions Inc Class I Ongoing Florida & Maryland Details
Devices Becton Dickinson & Co. Class II Ongoing Worldwide Distribution - USA including CA, FL, IN, IL, KS, NY, OH, OR, PA, TX, and WI and the country of Belgium Details
Devices Biomerieux Inc Class II Completed Distributed only in HI. Details
Biologics University Of Miami Miller School of Medicine Tissue Bank Class III Terminated Florida Details
Biologics University Of Miami Miller School of Medicine Tissue Bank Class III Terminated California Details
Biologics University Of Miami Miller School of Medicine Tissue Bank Class III Terminated Michigan; Nebraska; Florida; California; Kentucky Details
Biologics University Of Miami Miller School of Medicine Tissue Bank Class III Terminated Michigan; Kansas; Florida; Texas Details
Drugs L. Perrigo Co. Class III Ongoing Walmart Distribution Center in Bentonville, AR Details
Devices Biomerieux Inc Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of Algeria, Angola, Argentina, Australia, Austria, Azerbaidjian, Bahrain, Belarus, Belgium, Benin, Bolivia, Bosnia, Brazil, Bulgaria, Burkina Faso, Camaroun, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Democratic Republic of Congo, Demark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Myanmar, Netherlands, Netherlands, Nicaragua, Niger Niamey, Nigeria, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen. Details
Food Kettle Foods, Inc. Class III Terminated Product was distributed to 7 US consignees and 4 Canadian consignees. Details
Food Wholesale Baking, Inc. Class II Ongoing distributed directly to one sole consignee in Oregon Details
Veterinary Hy-Vee Stores Inc Class II Ongoing Distribution was made to 212 retail stores in IA, IL, MO, KS, NE, SD, MN and WI. Details
Drugs Hill Dermaceuticals, Inc. Class III Ongoing Nationwide Details
Devices Vital Images, Inc. Class II Ongoing Worldwide Distribution - All states in continental USA including DC, PR and the countries of ALGERIA, ARGENTINA, ANGOLA, ARMENIA, AUSTRALIA, AUSTRIA, BENGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL BULAGARIA, CAMBODIA, CANADA, CENTRAL AFRICAN REPUBLIC, CHAD, CHILE, CHINA , COLOMBIA, CONGO, CROATIA, CYRPRUS, CZECH REPUBLIC, DENMARK, DJIBOUTI, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GREAT BRITAIN, GEORGIA, GERMANY, GHANA, GREECE, GUAM, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, IVORY COAST, JAPAN, JORDAN, KAZAKHASTAN, KOREA, LEBANON, LITHUANIA, MACEDONIA, MALYASIA, MALI, MAURITIUS, MEXICO, MALDOVA, MOSCOW, NYNMAR, NAMBIA, NAMIRGIA, NEPAL, NETHERLANDS, NEW ZEALAND, NIGER, NIGERIA, NORTHERN IRELAND, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILLIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, RUSSIAN FEDERATION, SAUDI ARABIA, SENEGAL, SERBIA, SEBIA AND MONROBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOMALIA, SOUTH AFRICA, SPAIN, SRI LANKA, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, THE NETHERLANDS, TIBET, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBERKISTAN, VENEZUELA, VIETNAM and YEMEN. Details
Devices Microbiologics Inc Class II Ongoing Worldwide Distribution-USA including the states of CA, IN, MS, NY, OH, PA, and SD, and the countries of AUSTRALIA, AUSTRIA, UNITED ARAB EMIRATES, MALAYSIA, TAIWAN, JAPAN, TURKEY, BELGIUM, COLOMBIA, CANADA, SOUTH AFRICA, and VENEZUELA. Details
Devices Orthohelix Surgical Designs Inc Class II Ongoing Nationwide Distribution including the states of CA, CO, IL, MI, MD, NC, NM, OH, OK, PA, SD, TX, UT, VA, WA and WI. Details
Devices Genetic Testing Institute,inc Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain. Details
Devices Cooper Surgical, Inc. Class II Ongoing Worldwide Distribution -- USA, including the states of NE, MA, FL, TN, CA, ME, SC, CA, NH, OK, TX, NM, MO, NY, PA, and AZ, and countries of Germany, Italy, and Canada. Details
Devices Cooper Surgical, Inc. Class III Ongoing Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand. Details
Food Ultradent Products, Inc. Class III Ongoing USA: AL, CA, GA, IL, IN, MA, MD, MI, NJ, OK, PA, SC, UT; 12 International distributors: Germany, China, France, Spain Details
Devices Biosense Webster, Inc. Class II Ongoing Worldwide Distribution - USA (Nationwide) and countries of: DE, NL, CH, FR, GB, DK. Details
Drugs CareFusion 213, LLC Class II Ongoing Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom Details
Devices CareFusion 213, LLC Class III Ongoing USA Nationwide Distribution Details
Food Whole Foods Market Class I Ongoing TX Details
Drugs Zydus Pharmaceuticals USA Inc Class II Ongoing Nationwide. Details
Food Doctors Best Weight Loss Class I Terminated Canada Details
Devices Advanced Sterilization Products Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of Egypt, Germany, Italy, France, Saudi Arabia, UAE, Japan, Singapore, China, Thailand, Hong Kong, Hungary, Israel, Slovania, Poland, Czech Republic, Taiwan, Sweden, Greece, Korea, Ireland, and United Kingdom. Details
Devices Medtronic Inc. Cardiac Rhythm Disease Management Class II Ongoing Worldwide Distribution-USA including the states of FL, OH, and MN and the countries of Belgium, France Germany, Netherlands, Turkey, and United Kingdom. Details
Food Schwan's Corporate One Building HS/FS Class II Ongoing Continental USA (Schwan's Home Service, Inc., distributed to Residential customers) Details
Devices Medtronic Inc. Cardiac Rhythm Disease Management Class II Ongoing Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Canada, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, El Salvador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Israel, Italy, Jordan, Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Viet Nam. Details
Food Nishimoto Trading Co Ltd Class I Ongoing CA, HI, IL Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing Nationwide Distribution including AL, CA, CO, FL, IA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, ND, NJ, NY, OH, PA, SC, TX, UT, VA, WA, and WI and to Puerto Rico. Details
Devices Toshiba American Medical Systems Inc Class II Terminated USA nationwide. No international. Details
Devices Kimberly-Clark Corporation Class II Ongoing Worldwide Distribution -- USA, including the states of AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NV, NJ, NM, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, Belgium, Hong Kong, Japan, Portugal, and Singapore. Details
Drugs Pfizer Inc. Class III Ongoing Nationwide Details
Food Meijer Distribution, Inc Class II Ongoing Meijer stores in IL, IN, MI, OH, KY Details
Drugs Hospira Inc. Class II Ongoing Nationwide. Details
Food Decoty Coffee Company, Inc Class II Ongoing Mainly in TX, but internet sales were nationwide. Details
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