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U.S. Department of Health and Human Services

Enforcement Report - Week of February 20, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Food Altiza Inc. Class I Terminated CA Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Biologics American National Red Cross (The) Class II,Class III Terminated New York, California Details
Biologics American National Red Cross (The) Class III Terminated MO Details
Biologics American National Red Cross (The) Class III Terminated MO, AR, PR, SC, TN Details
Biologics Ogden Medical Center, Inc. Class II Terminated UT Details
Biologics ZLB Bioplasma, Inc. Class III Terminated NC, IL Details
Biologics ZLB Bioplasma, Inc. Class II Terminated NC, Switzerland, Germany Details
Biologics International BioResources, LLC Class III Terminated NC Details
Biologics Community Blood Center of the Ozarks Class II Terminated MO and Austria Details
Biologics ZLB Bioplasma, Inc. Class III Terminated IL, NC Details
Biologics American Red Cross Blood Services Class II Terminated Illinois Details
Biologics American National Red Cross (The) Class II Terminated MI. Details
Biologics Community Blood Center of the Ozarks Class II Terminated MO, Austria Details
Biologics American National Red Cross (the) Class II Terminated Connecticut, New York Details
Biologics American Red Cross Blood Services Class II Terminated Missouri Details
Biologics New York Blood Center, Inc. Class III Terminated N.Y. Details
Biologics LifeServe Blood Center Class III Terminated Iowa Details
Biologics Blood Systems, Inc. Class III Terminated TX Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated Austria, IN Details
Biologics Community Blood Center Of Gtr KC Class II Terminated KS, MO, IN, Austria Details
Biologics Blood Systems, Inc. Class II Terminated NM Details
Biologics American National Red Cross (The) Class II,Class III Terminated NH, VT Details
Biologics American National Red Cross (The) Class II,Class III Terminated NE Details
Biologics Talecris Plasma Resources, Inc. Class III Terminated NV. Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide Distribution. Details
Food He Butt Grocery Company Class I Completed TX Details
Devices Aesculap, Inc. Class II Ongoing Nationwide Distribution including MI, PA and TX. Details
Devices Bacterin International, Inc. Class II Ongoing Nationwide Distribution in TX and GA. Details
Devices GE Healthcare, LLC Class II Ongoing Nationwide Distribution - ALL STATES IN CONTINENTAL USA INCLUDING PR and DC excluding AK, DE, ND, and VT. ALGERIA, AUSTRALIA, ANGOLA, ARGENTINA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CUBA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GHANA, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNG ARIA, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAHSTAN, KENYA, KOREA, KUWAIT, LATIVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MEXICO, MALTA, MOROCCO, NEPAL, NETHERLAND, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PALESTINIAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN THAILAND, TRINIDAD AND TOBAGO,K TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARB EMIRATES , UNITED KINGDOM, URUGUAY. PUERTO RICO Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution and US (nationwide) including DC and the countries of ALGERIA, ARAB EMIRATES, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, GERMANY, INDIA, ISRAEL, ITA LY, JAPAN, JORDAN, KUWAIT, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE SLOVENIA, SOUTH KOREA, SPAIN SWEDEN SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM. Details
Veterinary Cohoons Elevator Inc. Class III Terminated Midland MI area only. Details
Devices GE Healthcare, LLC Class I Ongoing Worldwide Distribution - Worldwide Distribution - USA including AL, AZ, CA, CO, FL,GA, IA, ID, IL, KY, MA, MD, MI, MN, MO, MS, MT, NC, ND ,NE, NM, NV, NY, OH, OR, PA ,TX, VT, WA, WI and WV; and the countries of Australia, Belgium, Canada, China, France, New Zealand, Poland, Saudi Arabia, Switzerland and United Kingdom. Details
Devices Lumenis Limited Class I Ongoing Worldwide Distribution - US Nationwide including: CA, WI, NC, FL, PA, IN, NM, NJ, IA, WA, OH, FL, MD, MA, WY, NY, AZ, NH, MN, TN, OK, KY, TX, AK, MI, VT. Internationally: Japan, Nepal, India, UK, South Korea, Netherlands, Germany, Australia, China, Canada, Turkey, Spain, Italy, Egypt, Mexico, Bulgaria, Utd. Arab, Emir., Poland, Kuwait, Hong Kong, Saudi Arabia, Yemen, Qatar, Czech Republic, New Zealand, Malaysia, Portugal, France, Argentina, Singapore, Romania, Chile, Colombia, Switzerland, Bahrain, Brazil, Serbia/Montenero, Taiwan, Israel, Indonesia, Peru, Pakistan, Nepal, Belarus, Latvia, Sri Lanka, Russian Fed, Thailand, Azerbaijan, Belgium, and Denmark. Details
Drugs Upsher Smith Laboratories, Inc. Class II Ongoing FL, NJ. Details
Devices NAImco Inc dba Richmar Inc Class II Completed Distributed in the states of GA and TN. Details
Veterinary Dairy Manufacturers, Inc Class II Ongoing TX Details
Food Suadel Food Products, Inc. Class I,Class II,Class III Ongoing Puerto Rico only Details
Devices Mizuho OSI Class II Ongoing USA Distribution -- Worldwide Distribution including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, 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, SC, TN, TX, UT, VA, WA, WI, WV and WY., and the countries of Australia, Canada, Egypt, Finland, France, Germany, China, Israel, Italy, Japan, Netherlands, New Zealand, P.R. China, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Taiwan R.O.C.,UAE and UK. Details
Devices Quidel Corporation Class II Ongoing Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK Details
Devices Lockheed Martin Gyrocam Systems, Inc. Class II Ongoing Nationwide Distribution Details
Drugs Hospira Inc. Class II Ongoing Nationwide Details
Devices Philips Healthcare Inc. Class II Ongoing Worldwide Distribution - US Nationwide and the countries of: AUSTRALIA, AUSTRIA, BELGIUM,CANADA, CHILE, DENMARK, FRANCE GERMANY, ICELAND, INDIA, IRELAND,ISRAEL,ITALY, JORDAN, KENYA KUWAIT, LEBANON, MALAYSIA, NAMIBIA, NETHERLANDS, NEW ZEALAND NORWAY,PALESTINE, POLAND,PORTUGAL, SAUDI ARABIA, SINGAPORE SLOVENIA, SOUTH AFRICA, SOUTH KOREA,SPAIN,SWEDEN, SWITZERLAND THAILAND, TRINIDAD AND TOBAGO, UNITED ARAB EMIRATES UNITED KINGDOM Details
Drugs West-ward Pharmaceutical Corp. Class III Ongoing OH Details
Devices CHENICA INC. Class II Ongoing Nationwide Distribution-including the states of Florida, Michigan, South Carolina, California, Texas, Maryland, New York, Tennessee, Virginia, Illinois, Ohio, Massachusetts, Arizona and Washington. Details
Devices Viterion TeleHealthcare Llc Class II Ongoing Worldwide Distribution-USA (nationwide) and the United Kingdom. Details
Devices Mindray DS USA, Inc. d.b.a. Mindray North America Class II Ongoing Nationwide Distribution. Details
Devices St Jude Medical Inc Class I Ongoing Nationwide Distribution-including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TX, VA, WA, and WI. Details
Food Mann Packing Co Inc Class III Ongoing AZ, MN, CA , TX, ND, WI, NE, WA, AL, FL, NV , CO, AL, MO, KY, PA, SC. Details
Devices Fresenius Medical Care Holdings, Inc. Class II Ongoing Nationwide Distribution. Details
Devices Breg Inc Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia. Details
Drugs Lee Pharmaceuticals, Inc Class II Ongoing Nationwide Details
Food Pamela's Products, Inc. Class II Ongoing 36 distributors nationwide in AZ, CA, CO, CT, FL, GA, IA, IL, IN, MD, NJ, NJ, NV, OR, PA, SC, TN, TX, WA. Details
Devices GE Healthcare, LLC Class II Completed Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, FL, GA,IL,IN, IA, KS, KY,LA, MD, MA, MI, M, MO, NE, NE,NJ, NM, NY, NC, OH, OK PA, SC, TN, TX, UT, VA, WI. Internationally to UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, ROMANIA, PORTUGAL, POLAND, PERU, NORWAY, NEW ZEALAND, NETHERLAND, MALAYSIA, LITHUANIA, KUWAIT, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, ICELAND, HONG KONG, GERMANY, FRANCE, FINLAND, EGYPT, DENMARK, CZECH REPUBLIC, COLOMBIA, CHILE, CANADA, BELGIUM BAHRAIN, AUSTRIA, AUSTRALIA. Details
Biologics Ortho Clinical Diagnostics Inc Class III Terminated Colombia Details
Food Hoop Nuts LLC DBA Christophers Nut Co Class I Terminated CA Details
Devices Ultradent Products, Inc. Class III Ongoing Nationwide Distribution Details
Drugs Ranbaxy Inc. Class III Ongoing Nationwide and Puerto Rico Details
Food Tropical Nut & Fruit Co., Inc. Class I Ongoing Distribution Pattern: FL and NC Details
Food Diversified Foods & Seasonings, Inc. Class I Ongoing TN & MS Details
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