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U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Food Pacific American Fish Co Inc Class II Ongoing Nationwide in the US Details
Food Atlapac Trading Company Inc Class III Ongoing Distributed to US states. Details
Devices GE OEC Medical Systems, Inc Class I Ongoing Worldwide distribution. Details
Food Meiko Food Company Inc Class II Ongoing Retail supermarket in CA. Details
Food Arctic Zero, Inc. Class I Ongoing Nationwide in US Details
Food Namias dba Chonita Foods Class II Terminated Distributed solely to one customer in AZ. AZ only. Details
Devices Mallinckrodt Inc Class II Completed Worldwide distribution: USA (nationwide) including states of: AZ, CA, CO, GA, IL, KS, KY, LA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI, & WV and countries including: AUSTRALIA, BELGIUM, BRAZIL, CANADA, JAPAN & SINGAPORE. Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of Nationwide and worldwide: ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatamala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam. Details
Biologics LifeSouth Community Blood Centers Inc Class III Terminated AL Details
Biologics Blood Systems Inc Class II Terminated LA Details
Biologics American National Red Cross The Class II Terminated CA Details
Biologics American National Red Cross (the) Class II Terminated NC Details
Biologics Interstate Blood Bank, Inc. of Wisconsin Class II Terminated CA Details
Biologics Community Blood Center of Carolinas Class II,Class III Terminated NC and FL Details
Biologics Community Blood Center of the Ozarks Class II Terminated MO Details
Biologics Community Blood Center, Inc. Class II Terminated Switzerland; WI Details
Biologics American National Red Cross, Greater Ozark-Arkansas Region Class III Terminated AR Details
Biologics American National Red Cross Class III Terminated CA Details
Biologics Community Blood Center of the Ozarks Class II Terminated MO Details
Biologics Talecris Plasma Resources, Inc. Class III Terminated NC Details
Food Duane Reade Inc Class II Ongoing New York, New Jersey Details
Drugs Grandpa Brands Co Class II Ongoing Nationwide Details
Biologics Blood Assurance Inc Class II Terminated Tennessee Details
Biologics Blood Bank Of Hawaii Class II,Class III Terminated Hawaii; Austria Details
Biologics Atlanta Blood Services Class II Terminated Georgia Details
Devices Ortho-Clinical Diagnostics Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraquay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, UK, Northern Europe, France, Germany, Italy, Spain and Portugal. Details
Biologics Inland Northwest Blood Center Class II Terminated Arizona Details
Biologics American National Red Cross (the) Class II,Class III Terminated North Carolina and California Details
Biologics Community Blood Center Class II Terminated Ohio Details
Biologics Community Blood Bank of Erie County Class II,Class III Terminated Pennsylvania; Indiana Details
Biologics South Texas Blood & Tissue Center Class II Terminated Texas Details
Biologics The American National Red Cross - Southern Region Class III Terminated California Details
Biologics Hoxworth Blood Center UC Medical Center Class II Terminated Ohio 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 LifeShare Community Blood Services Class II Terminated Ohio Details
Devices Exactech, Inc. Class II Completed Worldwide Distribution-USA-including the states of CA, MA, OH, and OK, and the countries of Brazil, Colombia, France, Italy, Japan, Luxembourg, and Spain. Details
Biologics LifeSource Class II Terminated Illinois Details
Devices Getinge USA Inc Class II Ongoing Worldwide Distribution - USA including Maryland, Indiana, New Mexico, Massachuesetts, Texas, Kansas and the country of Canada Details
Devices CareFusion 303, Inc. Class I Ongoing US Nationwide Distribution Details
Food B & F, Inc., dba Hanmi, Inc Class II Ongoing Products were directly distributed in Alaska, Oregon and Washington. Details
Biologics American National Red Cross (The) Class III Terminated California Details
Biologics Arc Blood Services, New England Region Class III Terminated Missouri; 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
Food S Bertram Inc. Class II Ongoing Tri-state area of New Jersey, New York and Pennsylvania. Details
Devices Leica Microsystems, Inc. Class II Ongoing Worldwide Distribution - US (nationwide) in the states of: California, Colorado, Florida, Georgia, Illinois, Indiana, Massachusetts, Michigan, Minnesota, New York, Oklahoma, Oregon, Pennsylvania, Texas, Utah, West Virginia, including Puerto Rico, and the countriy of Canada. Details
Devices Tripath Imaging, Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, and WV and the countries of Belgium, Brazil, Canada, China, Columbia, Hong Kong, India, Japan, Korea, Peru, Singapore, Taiwan and Victoria (Australia). Details
Drugs Fougera Pharmaceuticals, Inc. Class III Ongoing Nationwide. 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
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 Ohio 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
Food Clorox Co (The) Class II Ongoing Michigan Details
Food Kettle Foods, Inc. Class II Ongoing 36 customers Worldwide Details
Food Hamchorom Inc. Class II Terminated CA Details
Devices Synthes USA HQ, Inc. Class II Ongoing Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, LA, MD, MN, NJ, NY, OH, PA, TN, TX, and VA. Details
Devices Synthes USA HQ, Inc. Class II Ongoing Nationwide Distribution including GA, PA, SC, TX, and UT. Details
Devices The Anspach Effort, Inc. Class II Ongoing US Nationwide Distribution including the states of: Arizona. and California. Details
Devices OrthoPediatrics Corp Class II Ongoing Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia. Details
Devices Stryker Howmedica Osteonics Corp. Class II Ongoing Worldwide Distribution Details
Devices GE OEC Medical Systems, Inc Class I Completed Worldwide Distribution Details
Devices GE OEC Medical Systems, Inc Class I Completed Worldwide Distribution - US Nationwide Details
Devices Respironics, Inc. Class I Ongoing Worldwide Distribution - USA including AZ, CA, IL, IN, LA, MI, MN, MO, NJ, NY, NC, PA, SC, TN, TX, and WI and the countries of Canada, Denmark, Estonia, Finland, France, Great Britian, India, Italy, Japan, Korea, Saudi Arabia, and Spain. Details
Food East Bay Seafood Co., Inc. Class II Completed IL, MA, NY, RI Details
Food Plenus Group Inc. Class II Ongoing Connecticut, Massachusetts, Maine and Rhode Island Details
Devices Beekley Corporation Class II Ongoing International Distribution including Nationwide(USA), and the countries of Japan and Canada. Details
Devices Bridgepoint Medical Class II Ongoing Worldwide distribution: USA (nationwide) including: AL, AZ, CA, CO, GA, IL, KY, MD, MN, MO, NC, NY, OR, PA, WA, and WI; and countries of: Australia and Sweden. Details
Devices Hill-Rom, Inc. Class II Ongoing Worldwide Distribution - US Nationwide and countries including: Argentina , Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guam, Guyana, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Malaysia, Mauritius, Mexico, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, Turks and Caicos Islands, United Arab Emirates, United Kingdom, United States, US Virgin Islands, Venezuela and Vietnam Details
Devices Stryker Howmedica Osteonics Corp. Class II Ongoing Nationwide Distribution Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing (USA) nationwide including the states of CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI. Details
Food 21st Century Foods, Inc. Class II Terminated CT and MA Details
Devices Philips And Neusoft Medical Systems Co., Ltd. Class II Ongoing Nationwide Distribution -- North Carolina, Ohio, and Texas. Details
Food Cass Clay Creamery AMPI Fargo Division Class I Ongoing MN, WI, ND and IA Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing Worldwide Distribution, including the state of Florida (USA) and the countries of Germany, India, Poland, Thailand, and the Republic of Korea. Details
Devices Westone Laboratories, Inc. Class II Ongoing Worlwide Distribution - US (nationwide) and to countries of: Australia, Belgium, Brazil, Canada, France, Germany, Greece, Hong Kong, Ireland, Japan, Korea, Mexico, Panama, Philippines, Russian Federation, and Singapore, Sweden, Switzerland and Thailand and United Kingdom. Details
Devices AGFA Corp. Class II Ongoing Nationwide Distribution including IN, SC, OH, TX Details
Food Southern Bakeries, LLC Class II Ongoing AL, GA, MS, TN, TX, and WI. Details
Devices Hospira Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of California, Colorado, Connecticut, Florida, Illinois, Kentucky, Maryland, Massachusetts, Minnesota, Oklahoma, Texas, Utah, Virginia, Washington, West Virginia and Wyoming, and the countries of Barbados and Canada. Details
Food Hanmi Incorporated Class II Ongoing The products were distributed to VA, MD, and PA Details
Food Wellements, LLC Class I Ongoing Nationwide and Canada Details
Drugs Stat Rx USA Class III Ongoing Nationwide Details
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