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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics American National Red Cross (The) Class II Terminated MO Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated NE, FL Details
Biologics Community Blood Center of the Ozarks Class II Terminated MO Details
Biologics American National Red Cross (The) Class II Terminated New York Details
Biologics LifeServe Blood Center Class II Terminated Ilinois Details
Biologics American National Red Cross (The) Class II Terminated New York Details
Biologics American National Red Cross Class II Terminated Oregon. Details
Biologics LifeServe Blood Center Class II Terminated Iowa Details
Biologics LifeServe Blood Center Class II Terminated Iowa Details
Biologics American National Red Cross (The) Class II Terminated NY, MD, and PA Details
Biologics LifeServe Blood Center Class II Terminated Iowa Details
Biologics LifeServe Blood Center Class II Terminated Iowa Details
Biologics Community Blood Center of the Ozarks Class II Terminated North Carolina; Missouri; Details
Biologics American National Red Cross Class II Terminated California. Details
Biologics New York Blood Center, Inc. Class III Terminated New York Details
Biologics Biomat USA, Inc. Class III Terminated Spain and California Details
Biologics American National Red Cross (The) Class II Terminated OH, NJ, GA, MO, NC, MI, SC, IN, and CA Details
Food Tropical Nut & Fruit Inc Class I Completed The recalled product was sold in Tropical's Outlet Store in Columbus, OH. Details
Food BA Sweetie Candy Co Class I Completed The product was distributed to one customer in Ohio. Details
Food Giannios Candy Co Inc Class I Terminated The product was distributed in the states of OH, PA, MI, NY. Details
Food Gorant Candies Inc A Division of Carlton Cards Retail Inc Class I Completed Product was distributed to wholesalers and retailers throughout the continental US and to Canada. US states product was distributed to includes: AL, AR, AZ, CA, CT, DE, FL, GA, IA, IL, IN, KY, MA, MD, MI, MS, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI. Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated NC Details
Biologics CSL Plasma, Inc. Class III Terminated Illinois, Germany, and Switzerland. Details
Food Tortilleria Provincia Class II Completed The product was only distributed in the state of Kentucky. Details
Biologics Ethicon, Inc. Class III Ongoing Nationwide and Foreign (Canada, Israel, Singapore, and Switzerland) Details
Drugs Hospira Inc. Class II Ongoing Nationwide Details
Biologics Community Blood Center Class II Terminated OH Details
Biologics LifeSouth Community Blood Centers Inc Class II Terminated AL Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated FL Details
Biologics LifeSouth Community Blood Centers Inc - Birmingham Region Class II Terminated AL Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated AL,FL Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated AL Details
Biologics Lane Memorial Blood Bank Class II Terminated Tennessee; Oregon Details
Biologics Community Blood Centers of Florida, Inc. Class II,Class III Terminated Switzerland; FL Details
Biologics D. D. Eisenhower Army Med. Ctr. - Blood Bank Class II Terminated NJ, FL Details
Biologics Community Blood Centers of South Florida, Inc. Class II,Class III Terminated Switzerland and FL Details
Devices Philips Healthcare Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Canada, Chile, Czech republic, Estonia,France, Germany, Hungary, Inida, Ireland, Italy, Japan, Libyan Arab Jamahari, Mexico, Netherlands, New Zealand, Norway , Oman, Panama, Peru, Poland, Qatar, Reunion, Russia, Saudi Arabia, South Africa, South Korea,Spain, Sweden, Swizerland, Thailand, UAE, and the UK. Details
Drugs Bristol Myers Squibb Manufacturing Company Class II Ongoing LA, TN, CA Details
Devices Beckman Coulter Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Austria, Brazil, China, Czech Republic, France, Germany, Hungary, India, Ireland, Israel, Italy, Korea Republic, Malaysia, Netherlands, Russian Federation, Spain, Switzerland, Taiwan, Turkey, United Kingdom, and Viet Nam. Details
Drugs Hospira Inc. Class II Ongoing Nationwide Details
Devices Becton Dickinson & Company Class III Ongoing Nationwide Distribution Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution - USA including the states of AR, CA, CO, FL, GA, IL IN, IA, LA, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, PA, PR, SC, SD, TN, TX and VA. and the countries of ALGERIA, AUSTRALIA, AUSTRIA, ARGENTINA, BELARUS, CANADA, CHINA, CHILE, EGYPT CZECH REPUBLIC, FRANCE, FINLAND, GERMANY, GABON, HONG KONG, INDIA, IRELAND, ITALY KENYA, KOREA, JAPAN, MEXICO, NIGERIA, PHILIPPINES, PORTUGAL REPUBLIC OF MALTA, RUSSIAN FEDERATION SAUDI ARABIA, SPAIN SWITZERLAND, TURKEY, TAIWAN, TUNISIA, UNTIED KINGDOM and VENEZUELA. Details
Drugs West-ward Pharmaceutical Corp. Class II Ongoing GA Details
Devices Ad-Tech Medical Instrument Corporation Class I Ongoing Worldwide Distribution - USA Nationwide including the states of CA, GA, LA, MA, MD, MI, MN, NH, PA, RI, TX, UT, WI and the countries of: Australia, CANADA, ENGLAND, JAPAN, KOREA, and SWITZERLAND. Details
Devices Synthes USA HQ, Inc. Class II Ongoing Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT. Details
Biologics Florida Lions Eye Bank, Inc. Class III Terminated Nationwide; Jamica; Costa Rica; Egypt, El Salvador, St. Thomas, Venezuela, Ecuador, China and Guatemala Details
Devices Siemens Medical Solutions USA, Inc Class II Terminated 5 devices, all located outside of the United States in Germany. Details
Food Ocean Beauty Seafoods, LLC Class I Ongoing Whole Market Foods in Seattle, WA Details
Food R-Kane Products Inc. Class II Ongoing Nationwide Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution - USA including the states of AL, AT, AZ, BAH, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NV, NY, OH, OR, PA, PR, PR, SC, TN, TX, VA, VT, WA, WI & WV. and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican, Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Gabon, Georgia, Germany, Greece, Guadeloupe, Guinea, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, LAO People's Dem, Rep., Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Malta, Martinique, Mexico, Netherlands, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela & Viet Nam. Details
Food Mkg Provisions Inc Class I Terminated FL and IL Details
Food Deep Foods Inc Class II Ongoing 27 states (Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Louisiana, Massachusetts, Maryland, Maine, Mississippi, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia and West Virginia. Details
Drugs Aaron Industries Inc Class III Ongoing Nationwide Details
Drugs Glenmark Generics Inc., USA Class III Ongoing Nationwide Details
Devices Ethicon Endo-Surgery Inc Class II Ongoing Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and, the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, GERMANY, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KUWAIT, LIBYAN ARAB JAMAHIRIYA, MALAYSIA, MEXICO, NETHERLANDS ANTILLES, NICARAGUA, NICOSIA, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PROVINCE OF CHINA, PUERTO RICO, REPUBLIC OF KOREA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA &, YEMEN. Details
Devices Linvatec Corp. dba ConMed Linvatec Class III Ongoing Worldwide Distribution - USA (nationwide) including the states of: CA, FL, GA, IL, KS, MA, MD, MO, NE, NY, and TX and the countries of: Canada, Germany, Romania, Spain, Palestine, South Africa, France, Sweden and Singapore Details
Food Decoty Coffee Company, Inc Class I Ongoing Mainly in TX but internet sales were nationwide. Details
Devices Salyer Prn Biomedical Class II Ongoing Distributed in the states of MA,CA, and WI. Details
Food Rich Products Corp Class II Ongoing NY, PA, VA, TN, IN, MI, WI, MN, SD, ND, IL, MO, NE, KS, OK, TX, CA, WA Details
Food Rich Products Corp Class II Ongoing CA, CO, TX, UT, SC, NC, WA, NM Details
Devices Atricure Inc Class II Ongoing Nationwide Distribution including the states of MD, PA and TX. Details
Devices Medtronic Inc. Cardiac Rhythm Disease Management Class II Ongoing Worldwide distribution, including USA nationwide, Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Viet Nam. Details
Food Herbalife International Of America Inc Class I Ongoing Worldwide distribution Details
Devices Bard Access Systems Class II Ongoing USA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America. Details
Devices Steris Corporation Class II Ongoing Worldwide Distribution - USA including Canada and the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, SK, TN, TX, UT, VA, VT, WA, WI, and WV. Details
Food Bruce Foods Corp Class I Ongoing VA, MN, IN Details
Devices Churchill Medical Systems, Inc. Class II Ongoing Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH. Details
Drugs Actavis Elizabeth LLC Class III Ongoing Nationwide Details
Drugs RX South LLC DBA RX3 Pharmacy Class II Ongoing Nationwide Details
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