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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Food G.L. Food Wholesale Inc Class III Ongoing CA, TX, IL, NV, OR, AZ, MO, NM, WA Details
Food Golden Dharma International Corp Class III Terminated California, New Jersey Details
Food Mandalay Trading Corporation Class III Ongoing CA, NV, NM, WA, GA, NJ, Details
Food Walong Marketing, Inc. Class III Ongoing nationwide Details
Biologics LifeServe Blood Center Class II Terminated Illinois Details
Biologics ZLB Bioplasma, Inc. Class II Terminated IL Details
Biologics LifeServe Blood Center Class II Terminated Iowa Details
Biologics American Red Cross Blood Services Class II Terminated Missouri Details
Biologics LifeServe Blood Center Class III Terminated Iowa Details
Biologics American Red Cross Blood Services Class II Terminated Missouri Details
Biologics American National Red Cross (The) Class II Terminated NE Details
Biologics Community Blood Center of the Ozarks Class II Terminated MO, Austria Details
Biologics Siouxland Community Blood Bank Class II Terminated IA, Austria Details
Biologics American Red Cross Blood Services Class II Terminated Missouri; Saipan Details
Biologics Siouxland Community Blood Bank Class III Terminated NC, FL Details
Biologics American National Red Cross (The) Class II Terminated NE, PA, NJ Details
Food WILDCAT CREEK POPCORN Class I Completed Product was shipped to stores in IN & OH. Details
Biologics American National Red Cross Class III Terminated Oregon. Details
Biologics American National Red Cross (The) Class II Terminated PA, CO Details
Biologics American National Red Cross (The) Class II Terminated Ohio, California. Details
Biologics American National Red Cross (The) Class II Terminated Medical Centers nationwide Details
Biologics CSL Plasma, Inc. Class III Terminated Illinois. Details
Drugs K C Pharmaceuticals Inc Class II Completed Nationwide Details
Biologics Talecris Plasma Resources, Inc. Class III Terminated NC Details
Drugs A B Nutrition, Inc. Class II Ongoing In retail store located in TX and internet sales nationwide. Details
Biologics BioLife Plasma Services L.P. Class III Terminated California, Austria Details
Devices Spine Smith Partners LP Class II Ongoing Distributed in Texas. Details
Food Whole Foods Market Class I Ongoing FL and CA Details
Food Talenti I, LLC Class I Ongoing Nationwide Details
Food Hines Nut Co Class I Ongoing Nationwide and Puerto Rico Details
Devices Instratek, Incorporated Class II Ongoing USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX. Details
Food Bakery Cash & Carry Inc. Class II,Class III Ongoing Puerto Rico only Details
Biologics Mississippi Blood Services Inc. Class II Terminated Mississippi Details
Biologics Florida's Blood Centers - Lake Park Class II Terminated Florida Details
Biologics Florida's Blood Centers, Inc. Class II Terminated Florida Details
Biologics Amer. National Red Cross-Greater Chesapeake & Potomac Reg. Class II Terminated District of Columbia; Maryland Details
Biologics Community Blood Center of Carolinas Class II Terminated North Carolina Details
Biologics Blood Bank Of San Bernardino And Riverside Counties Class II Terminated California Details
Biologics Virginia Blood Services Class II Terminated Virginia Details
Biologics Memorial Blood Centers Class III Terminated Michigan Details
Biologics HCSC-Blood Center Class III Terminated Pennsylvania Details
Biologics Memorial Blood Centers Class II Terminated New Jersey; New York Details
Biologics St Mary's Hospital and Medical Center, Inc. Class II Terminated Colorado Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated Alabama; Georgia Details
Biologics LifeSouth Community Blood Centers Inc - Birmingham Region Class II Terminated Alabama Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated Georgia Details
Biologics LifeSouth Community Blood Centers Inc Class III Terminated Alabama Details
Biologics LifeSouth Community Blood Centers Inc - Birmingham Region Class II Terminated Alabama Details
Devices Abbott Medical Optics Inc (AMO) Class II Ongoing Worldwide Distribution - USA Nationwide including the state of OH and the countries of: Germany, Switzerland, Sweden, Italy, China, France, Singapore, UK, Croatia, Hungary, Turkey and Brazil. Details
Drugs AstraZeneca LP Class III Ongoing Nationwide Details
Devices Siemens Healthcare Diagnostics, Inc. Class III Ongoing Nationwide Distribution Details
Food JMT Trading Company, Inc. Class III Ongoing CA Bay area and one location in HI. Details
Devices Synthes USA HQ, Inc. Class II Ongoing USA Nationwide Distribution including the states of AL, AR, AK, CA, FL, ID, KS, LA, MD, MA, MO, NJ, NY, OH, PA, TN, TX, and VA. Details
Devices Elekta, Inc. Class II Ongoing Nationwide Distribution-DC, Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI. Details
Devices Synthes USA HQ, Inc. Class II Ongoing Distributed in the states of AL, CA, MS, MO, NJ, OR, and TN. Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, ME, MD, MA, MN, MS,MO, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT , VA, WA, WV, WI and the countries of VENEZUELA, UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, SPAIN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, POLAND, NORWAY, NIGERIA, NICARAGUA, MOROCCO, MALTA, LEBANON, KAZAKHSTAN, JAPAN, ITALY, INDONESIA, INDIA, HUNGARY, GREECE, FRANCE, EGYPT, CHINA, CANADA, BRAZIL, BELGIUM, and NEW ZEALAND. Details
Biologics Smiths Medical ASD, Inc. Class II Ongoing Nationwide Foreign: Canada, Mexico, Santo Domingo, Panama, Equador, Chile, Portugual, Qatar, Ireland, Libiya, UAE, Great Britain, India,Germany, Italy, Oman. Belgium, Netherlands, Switzerland, Australia, Austria, Poland, Romania, Hungary, Vietnam,Egypt, Japan, Spain Details
Devices Siemens Medical Solutions USA, Inc. Class II Ongoing Worldwide Distribution - USA including WV and OH; Internationally to Australia, Austria, Bahrain, Belgium, Brazil, China (P.R.) Estonia, France, Germany, Greece, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Macedonia, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Qatar, Rep of Korea, Romania, Sweden, Taiwan, Thailand, Turkey, Unite Arab Emirates, United Kingdom and Venezuela. Details
Drugs Teva Pharmaceuticals USA, Inc. Class II Ongoing Nationwide Details
Devices Medtronic Navigation, Inc. Class II Ongoing Worldwide Distribution - USA Nationwide and the countries of: Canada, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CHILE, CHINA, CROATIA, CZECH REPUBLIC, DENMARK,FINLAND, FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN ,KOREA, REPUBLIC OF KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, MEXICO, NETHERLANDS, New Zealand, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, Taiwan(R.O.C.) , THAILAND, TURKEY, UNITED ARAB EMIRATES. and UNITED KINGDOM. Details
Drugs Fresenius Kabi USA LLC (FK USA) Class III Ongoing Nationwide Details
Devices GE Healthcare, LLC Class II Completed Worldwide Distribution-USA including the states of FL, IL, IN, NJ, NC, OK, TX, and WI, and the countries of UNITED KINGDOM, TUNISIA, SERBIA, RUSSIAN FEDERATION, NORWAY, NIGERIA, LITHUANIA, LEBANON, KOREA, REPUBLIC OF KOREA, ITALY, INDONESIA, INDIA, FRANCE, FINLAND, COLOMBIA, CHINA, and BRAZIL. Details
Food Phil-Am Trading, Inc. Class III Ongoing 74 customers mainly located in NJ, NY and Pennsylvania. Details
Devices Synthes USA HQ, Inc. Class II Ongoing Worldwide Distribution -- USA, including the states of CA, LA, MA, NY, and PA, and the countries of Canada and Switzerland. Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution - USA (All States in continental USA including PR except RI.). Internationall to: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BRAZIL, BELARUS, BELGIUM, BULGARIA, BOSNIA & HERZEGOVINA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, GERMANY, GREECE, GUADELOUPE, HONDURAS, HUNGARY, INDIA, INDONESIA, IRAN, ISLAMIC REPUBLIC OF IRAN, IRAQ, ITALY, IRELAND, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, KAZAKHSTAN, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MACEDONIA, MARTINIQUE, MOROCCO, NETHERLANDS, NORWAY, PAKISTAN, PERU, PHILIPPINES, REUNION, NEW ZEALAND, OMAN, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SINGAPORE , SLOVAKIA, SOUTH KOREA, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TURKEY, TUNISIA, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, URUGUAY, VIET NAAM, and YUGOSLAVIA. Details
Food Farmers Cooperative Creamery Class III Ongoing Product was directly distributed in California, Oregon, and Washington. Details
Devices Stryker Howmedica Osteonics Corp. Class II Ongoing Nationwide Distribution. Details
Food Inventure Foods, Inc. Class II Ongoing AZ, KY, IL, NJ, GA, FL, MN, CA, CO, and TX. Details
Devices Integra LifeSciences Corp. Class II Ongoing Worldwide Distribution - USA and the countries of Austria, Australia, Bangladesh, Belgium, Bulgaria, Brazil, Switzerland, Canada, China, Costa Rica, Czech Republic, Germany, Dominican Republic, Egypt, Emirates, Spain, Finland, France, Great Britian, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Italy, Japan, Korea (South), Kuwait, Lebanon, Sri Lanka, Latvia, Macedonia, Mexico, Malaysia, Netherlands, Philippines, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Singapore, Slovenia, Thailand, Tunisia, Taiwan, United Arab, Viet Nam and South Africa. Details
Devices Diagnostica Stago, Inc. Class II Ongoing Worldwide Distribution - USA and Canada. Details
Devices Bacterin International, Inc. Class II Ongoing 13 US consignees located in CA, CO, MT, TX, UT, and VA. This represents 4 customers and 9 other individual contacts in USA that received marketing samples. Plus 4 Bacterin representives nationwide received samples. Foreign Consingee Details
Food LYFE Kitchen Retail, Inc. Class II Terminated CA and NV Details
Devices Smith & Nephew Inc Class II Ongoing Worldwide Distribution - USA including NM, TN, TX, NC, CA, MI, KY, MA, NJ, OH, and HI. Internationally to Canada, United Arab Emirates, Mexico, Argentina, Japan, and Chile. Details
Devices Sorin C.R.M., srl Class II Ongoing Worldlwide Distribution - USA (Nationwide) and worldwide to Argentina, Australia, Austria, Belgium, Brazil, Canada, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Morocco, The Netherlands, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Ukraine, Uruguay and the United Kingdom. Details
Devices Innominata Dba Genbio Class II Completed Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI. Details
Food Kellogg Company Class II Ongoing Distribution centers in GA, CA, PA, IL with further distribution nationwide. No Canadian or outside USA distribution. Details
Devices Biomet, Inc. Class II Ongoing Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile Details
Food Ethnic International Holding Inc Class II Ongoing Connecticut, Georgia, Massachussets, Maryland, New Jersey, New York, Tennessee and Virginia. Details
Food Dakota Specialty Milling, Inc Class II Ongoing AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI. Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing Nationwide Distribution. Details
Biologics Immucor Inc Class III Ongoing Nationwide, Canada, Columbia, England, Germany, Japan, Norway, Peru, South Africa, and South Korea. Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution - Nationwide 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. Details
Food Frito-Lay, Inc Class II Ongoing Nationwide through grocery outlets, foodservice, and vending customers. Details
Food Mondelez Global Llc Class II Ongoing Nationwide and Puerto Rico Details
Drugs Humco Holding Group, Inc Class II Ongoing Nationwide Details
Devices Genesys Orthopedic Systems, LLC Class II Ongoing USA Nationwide Distribution including the states of: CA and TX. Details
Devices Symbios Medical Products, LLC Class I Ongoing Nationwide Distribution including PA, CA, OH, AL, FL, WV, TN, NJ, NC, TX, CO, NY, TX, MO, MS, SC, and GA. Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution - USA including AR, AZ, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, WY, and worldwide including the contries of Australia, Belgium, China, France, Germany, Israel, Japan, Norway, Sweeden, and Switzerland. Details
Food The King Arthur Flour Company, Inc. Class II Ongoing Nationwide Details
Devices Draeger Medical, Inc. Class II Ongoing Distributed in the states of CA, IL, and MA. Details
Devices Vygon Corporation Class II Ongoing Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania Details
Devices Keystone Dental Inc Class II Terminated Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI. Details
Devices Natus Neurology Incorporated Class II Ongoing Worldwide Distribution - USA Nationwide including the states of CA, FL, LA, MD, MS, MO, NJ, NY, PA, TX and the country of AUSTRALIA. BAHRAIN BRAZIL CANADA Country DENMARK EGYPT GERMANY HONG KONG INDIA INDONESIA IRELAND ITALY JAPAN KOREA KUWAIT MALAYSIA MEXICO NETHERLANDS ROMANIA RUSSIA SINGAPORE SPAIN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM URUGUAY VIET NAM Details
Food Koda Farms Inc Class II Ongoing NY, MD, CA, HI, WA, Details
Food Publix Super Markets, Inc. Class I Completed Florida Details
Food Whole Foods Market Class II Ongoing AL, DC, GA, MD, NC, NJ, PA, SC, TN, and VA. Details
Food See's Candies Inc. Class I Ongoing See Candies stores in CA, AZ, NM, MO, OK, NV, UT, TX. Details
Food Food For Life Baking Company Inc. Class II Ongoing US states and Canada. Details
Drugs RX South LLC DBA RX3 Pharmacy Class II Ongoing Nationwide Details
Food Riggio Dist Co Class II Ongoing Distributor and retail stores in Illinois and Michgan Details
Devices Hill-Rom, Inc. Class II Ongoing USA Nationwide Distribution including the state of Canada Details
Food Bay Valley Foods LLC/ TreeHouse Foods, Inc Class II Ongoing CA, FL, GA, IL, IN, KY, LA, MD, MI, MS, NY,NC, OH, OK, PA, TN, TX, UT, VA, WA, WI. Details
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