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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Micro Typing Systems Inc. Class II Terminated The product was distributed to 79 consignees throughout the USA and Canada. Details
Devices Biosense Webster, Inc. Class II Terminated Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Denmark, France, Germany, Israel, Italy, Netherlands, and United Kingdom. Details
Biologics Life Technologies, Inc. Class II Ongoing Nationwide; CANADA, BRAZIL, GERMANY, ALGERIA, ESTONIA, SPAIN, FRANCE, GREAT BRITAIN, HONG KONG, ISRAEL, ITALY, JAPAN, POLAND, ROMANIA, SAUDI ARABIA, SWEDEN, SINGAPORE, TUNISIA, TAIWAN, URUGUAY, SOUTH AFRICA. Details
Biologics D. D. Eisenhower Army Med. Ctr. - Blood Bank Class III Terminated NJ Details
Devices JK Products & Services, Inc Class II Ongoing Worldwide Distribution - USA (nationwide) and Canada Details
Veterinary Process Managers LLC Class II Ongoing Nationwide distribution: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, KY, LA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, SC, TX, UT, VA, WA & WV. No shipments were made to foreign countries including Canada. Details
Biologics Blood Systems, Inc. dba United Blood Services Class III Terminated TX Details
Biologics Florida's Blood Centers, Inc. Class II Terminated FL Details
Biologics Plasmacare Inc Class III Terminated CA Details
Biologics Plasmacare Inc Class III Terminated CA Details
Biologics Plasmacare Inc Class III Terminated CA Details
Biologics Plasmacare Inc Class III Terminated CA Details
Biologics Plasmacare Inc Class III Terminated CA Details
Biologics Plasmacare Inc Class III Terminated CA Details
Biologics Plasmacare Inc Class III Terminated California Details
Biologics Plasmacare Inc Class III Terminated CA Details
Biologics Plasmacare Inc Class III Terminated CA Details
Biologics Plasmacare Inc Class III Terminated CA Details
Biologics Plasmacare Inc Class III Terminated CA Details
Biologics Plasmacare Inc Class III Terminated CA Details
Biologics Plasmacare Inc Class III Terminated CA Details
Devices Exactech, Inc. Class II Ongoing Nationwide distribution: USA state of: Arkansas only Details
Biologics Plasmacare Inc Class III Terminated CA Details
Biologics Plasmacare Inc Class III Terminated CA Details
Biologics Plasmacare Inc Class III Terminated CA Details
Biologics Plasmacare Inc Class III Terminated CA Details
Biologics Plasmacare Inc Class III Terminated CA Details
Biologics Plasmacare Inc Class III Terminated CA Details
Biologics American Red Cross Blood Services Class III Terminated CA Details
Biologics Community Blood Centers of Florida, Inc. Class II,Class III Terminated Switzerland; FL Details
Biologics Community Blood Centers of Florida, Inc. Class II,Class III Terminated Switzerland; FL, NY Details
Biologics South Dakota Lions Eye and Tissue Bank, Inc. Class II Terminated NC, Egypt Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide distribution: International only-country of: Terumo Dubai, UAE Details
Devices Philips Healthcare Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of : AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CAMBODIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND FRANCE GERMANY GREECE GUADELOUPE HONG KONG ICELAND INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KOREA, REPUBLIC OF KUWAIT LAOS LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAYSIA MALTA MEXICO MOROCCO NAMIBIA NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN PAKISTAN PANAMA PAPUA NEW GUINEA PARAGUAY PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM YEMEN Details
Biologics Indiana Blood Center Class II Terminated Indiana Details
Biologics Community Blood Bank of Erie County Class II Terminated Pennsylvania Details
Biologics LifeSouth Community Blood Centers Inc - Birmingham Region Class II Terminated Alabama Details
Biologics Blood Systems, Inc. dba United Blood Services Class II Terminated Texas Details
Food Sunny Seafoods Inc Class II Ongoing Massachusetts to Georgia. Details
Biologics Blood Systems, Inc. dba United Blood Services Class II Terminated Texas Details
Biologics Blood Systems, Inc. dba United Blood Services Class II Terminated Texas Details
Biologics Florida's Blood Centers, Inc. Class II Terminated Austria; Florida Details
Biologics Dci Biologicals Llc Class II Terminated Israel Details
Biologics Meek Blood Center Class II Terminated Texas Details
Biologics Florida's Blood Centers, Inc. Class II Terminated Florida Details
Biologics LifeSouth Community Blood Centers Inc - Birmingham Region Class II Terminated Alabama Details
Biologics BloodCenter of Wisconsin, Inc Class II Terminated Wisconsin Details
Biologics Arup Laboratories, Inc. Class II Terminated Utah Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Missouri Details
Veterinary Nutra Blend LLC Class II Terminated The product was distributed in MO. Details
Food Garden-Fresh Foods, Inc. Class I Ongoing AZ CA FL IA IL IN MA MI MN MO OH PA TX WI Details
Food Ron Stockman Whole Foods Class I Ongoing Products were sold directly to the consumers though our Whole Foods Market Retail stores in the state of Florida. Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, HI, IK, IL IN, IA, KS, LA, MD, MA, MI, MN,MO, NV, NH, NH, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI,.and internationally to: AUSTRALIA, AZERBAIJIN, BAHRAIN, BELARUS, BULGARIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, INDIA, INDONESIA, IRAQ, IRELAND, ITALY, JAPAN, KUWAIT, LEBANON, LIBYA, MALAYSIA, MEXICO, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAÚDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, TAIWAN, THAILAND, UNITED ARAB EMIRATES, UNITED KINGDOM, and YEMEN. Details
Devices Sunquest Information Systems, Inc. Class II Completed Worldwide distribution: USA (nationwide) and countries of: England, United Kingdom and United Arab Emirates. Details
Devices C.R. Bard, Inc., Urological Division Class II Ongoing Nationwide distribution: USA Details
Food Missa Bay, LLC Class I Ongoing Alabama, Arkansas, Connecticut, Delaware, DC, Florida, Georgia, Florida, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carlina, South Dakota, Tennessee, Vermont, Virginia, Wisconsin, and West Virginia. Details
Devices Intuitive Surgical, Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Canada, and Lebanon Details
Devices Aesculap Implant Systems LLC Class II Ongoing Nationwide Distribution-including the states of IL, MN, NV, OK, and TX. Details
Devices Capsule Tech Inc. Class II Ongoing Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Denmark, France, Germany, Netherlands and UK. Details
Devices Custom Medical Specialties, Inc. Class II Terminated Nationwide Distribution including GA, MI, NY, and PA. Details
Food Meijer Distribution, Inc Class III Ongoing The 4 oz. product was distributed to 25 stores and the. 8 oz. product was distributed to 197 stores. Stores are located in Illinois, Indiana, Kentucky, Michigan, and Ohio. Product was distributed from Meijer's distribution centers located in lansing, Michigan; Newport, Michigan; and Tipp City, Ohio. Details
Devices Steris Corporation Class II Ongoing Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong. Details
Devices Hospira, Inc. Class II Ongoing Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, NK, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY and the countries of Canada, Costa Rica and the Virgin Islands. Details
Devices Omni Life Science Class II Ongoing Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands. Details
Veterinary Steve Pritchett Farms LLC Class II Ongoing The firm distributed to one firm in Indiana. Details
Devices Elekta, Inc. Class II Ongoing Nationwide Distribution including DC & MD Details
Food T.F. Foods Incorporated Class II Terminated Firm distributed to 6 direct consignees located in CA and NY. Details
Veterinary Breadfarm Class II Terminated Retail sales at firm only. Details
Devices Advanced Sterilization Products Class III Ongoing Nationwide Distribution. Details
Devices Lucero Medical LLC Class II Ongoing US Nationwide Distribution Details
Veterinary Greer Laboratories Inc Class III Terminated FL, IL, KS, MS, NJ, NY, OH, VA & Australia Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution -- USA (nationwide) Distribution Details
Food Atlas Operations, Inc. Class II Ongoing Distributed to one direct account in Florida who further distributed the entire shipment to one account in Dallas, TX. Details
Devices Helix Medical LLC Class III Ongoing Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom Details
Devices Siemens Medical Solutions USA, Inc Class II Completed Nationwide distribution: USA including states of: IN, MI, MS, TN and TX. Details
Devices Siemens Medical Solutions USA, Inc Class II Completed US Nationwide Distribution including the states of: GA, IA, KS, NC and TX. Details
Devices Medtronic Xomed, Inc. Class II Ongoing Worldwide distribution: USA (nationwide) and countries of: Australia, Austria, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Lebanon, Libya, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudia Arabia, Singapore, Slovak, Spain, SRI Lanka, Sweden, Turkey, United Arab Emirates, and United Kingdom. Details
Devices Volcano Corporation Class II Ongoing Worldwide Distribution. Details
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