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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics The American National Red Cross - Southern Region Class II,Class III Terminated AL, CA, CT, FL, GA, MS, NC, PA, SC & TX Details
Biologics American National Red Cross (The) Class II,Class III Terminated OH , CA. Details
Biologics American National Red Cross (The) Class II Terminated Ohio. Details
Biologics American National Red Cross (The) Class II Terminated Ohio. Details
Biologics American National Red Cross (The) Class II Terminated The ARC Blood Center in Cleveland, OH distributed products to three hospitals in Ohio. Details
Biologics American National Red Cross (The) Class II,Class III Terminated Ohio. Details
Biologics American National Red Cross (The) Class II,Class III Terminated CA Details
Biologics American National Red Cross (The) Class III Terminated CA Details
Biologics The American National Red Cross - Southern Region Class III Terminated GA, AR Details
Biologics American National Red Cross (The) Class II Terminated CA. Details
Biologics Biomat USA, Inc. Class III Terminated Blood products were released for distribution in a foreign country. Details
Biologics Sacramento Medical Foundation Class III Terminated CA. Details
Biologics Sacramento Medical Foundation Class II Terminated CA. Details
Biologics Sacramento Medical Foundation Class III Terminated CA. Details
Biologics Biomat USA, Inc. Class III Terminated MA. Details
Biologics Biomat USA, Inc. Class II Terminated Spain Details
Biologics American National Red Cross (The) Class III Terminated CA Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Biologics American National Red Cross (The) Class II Terminated CA Details
Biologics American National Red Cross (The) Class III Terminated CA Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Biologics BioLife Plasma Services L.P. Class III Terminated CA Details
Biologics American National Red Cross (The) Class II,Class III Terminated CA Details
Biologics New York Blood Center,inc-cellular Therapy Laboratory Class III Terminated NY Details
Biologics Blood Centers of the Pacific Class II Terminated CA Details
Biologics Community Blood Center of Greater Kansas City Class II Terminated MO Details
Biologics ZLB Bioplasma Services Class III Terminated NC Details
Biologics Coral Blood Services, Inc. Class II Terminated ME Details
Biologics ZLB Bioplasma Services Class III Terminated NC, Switzerland Details
Biologics Blood Centers of the Pacific Class II Terminated CA Details
Biologics Blood Centers of the Pacific Class II Terminated CA and Austria Details
Biologics ZLB Bioplasma Services Class II Terminated NC, Germany Details
Biologics ZLB Bioplasma Services Class II Terminated NC Details
Biologics ZLB Bioplasma Services Class II Terminated NC Details
Biologics ZLB Bioplasma Services Class II Terminated Switzerland, NC Details
Biologics ZLB Bioplasma Services Class II Terminated NC Details
Biologics Hoxworth Blood Center University of Cincinnati Medical Center Class II Terminated OH. Details
Biologics Hoxworth Blood Center University of Cincinnati Medical Center Class II Terminated OH, KY Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Biologics Blood Centers of the Pacific Class II Terminated CA, Austria Details
Biologics American National Red Cross (The) Class II Terminated OH Details
Biologics American National Red Cross (The) Class II Terminated KY, IN, CA. Details
Drugs Pack Pharmaceuticals Class III Terminated Nationwide Details
Food Nutri-Health Supplements Llc. Class I Ongoing Distributed to retail natiowide to US states. Details
Biologics Florida's Blood Centers, Inc. Class II Terminated FL, CA, NY, NC, SC Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated NC Details
Biologics Plasma Biological Services Inc Class III Terminated Austria, Ireland, CA, PA Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated CA. Name and address of consignee involved: Talecris Biotherapeutics, Inc. (TBI), 8368 US 70 Business Highway West, Clayton, NC 27520 Details
Biologics Blood Systems, Inc. Class III Terminated NM Details
Biologics Allograft Innovations, LLC Class II Ongoing Affected products were distributed to Israel, South Korea, United Kingdom , Turkey and domestically to TX, FL, MI, IN, NJ, IL, MO AZ, OK, OK and WI. Details
Veterinary Cargill Inc Animal Nutrition Division Class I Ongoing LA, MS, TN Details
Devices Epocal Inc Class II Ongoing US nationwide Distribution in the state of CA. Details
Devices Etac Supply Center Ab Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, China, Colombia, Germany, Denmark, Estonia, Spain, Finland, France, Great Brittain, Greenland, Greece, Hungaria, Ireland, Israel, Iceland, Italy, Japan, South Korea, Kuwait, Lithuania, Luxembourg, Latvia, Malaysia, Netherlands, Norway, Poland, Portugal, Rumania, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, and Thailand. Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, BANGLADESH, BELGIUM, Bolivia, BRAZIL, BRISBANE, CANADA, CHILE, China, COLOMBIA, COLOMBIA, Costa Rica, DENMARK, Dominican Republic, Ecuador, Egypt, FRANCE, GERMANY, Guatemala, HOLLAND, Honduras, Hong Kong, India, INDIA, Indonesia, Israel, ITALY, Jordan, KOREA, Kuwait, Lebanon, LEICESTERSHIRE, Malaysia, Mexico, NETHERLANDS, New Zealand, Nicaragua, NORWAY, Pakistan, Panama, PERU, Philippines, Russia, Saudi Arabia, SINGAPORE , SOUTH AFRICA, South Korea, SPAIN, Sri Lanka, SWEDEN, SWITZERLAND, Taiwan, THAILAND, Turkey, UNITED ARAB EMIRATES (UAE), Uruguay, Venezuela, Vietnam, WEST GERMANY and Yemen. Details
Drugs Hospira Inc. Class I Ongoing Nationwide Details
Drugs Meda Pharmaceuticals Inc. Class II Ongoing Nationwide Details
Devices Sigma Class III Ongoing Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada. Details
Drugs Luitpold Pharmaceuticals, Inc. Class II Ongoing Nationwide Details
Devices Stryker Spine Class II Ongoing Nationwide. Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV. and the countries of ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, 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
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of , AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam. Details
Devices Becton Dickinson & Co. Class II Completed Nationwide Distribution. Details
Food Old Fashioned Foods, Inc. Class II Ongoing CA, MI, OH, WI Details
Veterinary Natural Balance Pet Food Inc. Class I Ongoing Nationwide: PA, NC, AL, FL, OH, WI, MN, IL, MI, NJ, GA, TX, MA, CA Worldwide: Taiwan, Israel, and Canada. Details
Veterinary Pegasus Laboratories, Inc. Class II Ongoing Product was distributed to FL, OR, OH, PA, CA, TX, MO, NY, MN, IA, NE, NJ. Details
Drugs Bayer Healthcare, LLC Class III Ongoing Product was distributed to 93 retail accounts/customers. Details
Drugs JHP Pharmaceuticals, LLC Class III Ongoing Nationwide and Puerto Rico Details
Devices EKOS Corporation Class II Ongoing Worldwide Distribution - USA including OH, KY, and TN and the countries of Switzerland, Germany, Austria, Czech Republic, Slovakia Republic, Poland, Netherlands, Belgium, Luxembourg, United Kingdom, Republic of Ireland, Slovenia, Costa Rica, Argentina, Brazil, Dominican Republic, Taiwan, Korea, Greece, Mexico, Italy, Uruguay, Paraquay, Yugoslavia, New Zealand, India, Venezuela, South America, Norway, Sweden, Denmark, Turkey, Great Britain, Israel, Spain, Portugal, Greece, Korea, China, and Japan. Details
Devices Stingray Surgical Products, LLC Class II Ongoing Worldwide Distribution - USA (nationwide) Details
Devices Stryker Howmedica Osteonics Corp. Class II Ongoing Nationwide. Details
Veterinary Franck's Lab Inc., d.b.a. Franck's Compounding Lab Class II Ongoing Distributed to Veterinary Clinics and Veterinarians by perscription Nationwide and Internationally to Hong Kong, Trinidad, Grand Cayman Islands, and Columbia. Details
Devices B. Braun Medical, Inc. Class I Ongoing Nationwide Distribution-including Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI. Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution -- USA (nationwide) including the states of AK, CA, IL, MS, NJ, PR, SD, TN, TX, and VA. and the countries of ARGENTIAN, AUSTRALIA, BELGIUM, CHINA, GERMANY, ALGERIA, ECUADOR, EGYPT, FINLAND, UNITED KINGDOM, JORDAN, JAPAN, MOROCCO, MAURITUS, NETHERLANDS, OMAN, PERU, SEBIA, SUDI ARABIA, SINGAPORE, EL SALVADOR, TURKEY, URUGUAY and SOUTH AFRICA. Details
Devices Critical Diagnostics Class III Terminated USA including the state of California and the countries of Austria, Spain, United Kingdom, and Italy. Details
Devices Teleflex Medical Class II Ongoing Worldwide Distribution - U.S. (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Chile, China, Europe, India, Japan, Mexico, South Korea, Taiwan and UK. Details
Devices Alere San Diego, Inc. Class II Ongoing US Nationwide Distribution Details
Food SunOpta Ingredients Group (Corporate HQ) Class II Ongoing Arizona, Michigan, Virginia, and Holland Recall expanded on 6/19/12 to include California. Details
Devices Abbott Molecular Class II Ongoing California, Florida, Maryland, Oregon and Virginia, and internationally to Belgium, Brazil, China, France, Germany, Hong Kong, Japan, Malaysia, Mexico, Qatar, Switzerland and United Kingdom Details
Food Truitt Bros., Inc. Class II Ongoing Product was directly distributed to California, Oregon, and Washington. Details
Devices LMA North America Inc Class II Completed Worldwide Distribution--USA (nationwide) and the countries of Canada, United Kingdom, ZA, and Australia. Details
Food Itoen (USA) Inc Class II Ongoing CA Details
Devices CareFusion 203, Inc. Class I Ongoing Nationwide Distribution including AZ, CA, CO, FL, IL, KY, ME, MI, MO, MN, MT, ND, NJ, NM, NV, NY, OK, PA, SC, SD, TX , UT, WI, and WV. Details
Devices Hitachi Medical Systems America Inc Class II Ongoing US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX. Details
Devices GE OEC Medical Systems, Inc Class II Ongoing Worldwide Distribution. Details
Devices Gulf Fiberoptics, Inc. Class II Ongoing Worldwide distribution: USA (nationwide) including states of: AL, CA, CO, FL, MI, NC, NJ, NY, OH, PA, TN, TX and WI and country of: South Africa. Details
Devices Varian Medical Systems, Inc. Oncology Systems Class II Ongoing Worldwide distribution: USA (nationwide) and countries including of: Austria, Australia, Bahrain, Belgium, Brazil, Canada, China, Chile, Colombia, Denmark, Egypt, Finland, France,Germany, Greece, Hungary, Hong Kong, India, Indonesia, Israel, Ireland, Italy, Japan, Latvia, Malaysia, Mexico, Morocco, Nepal, Netherlands, Norway, Panama, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, United Kingdom, Taiwan, Turkey, Ukraine, United Arab Emirates and Venezuela. Details
Devices Spacelabs Healthcare, Llc Class II Ongoing Worldwide Distribution - USA including Florida, Iowa, Oklahoma, South Caroline and the countries of India, Germany and Panama. Details
Devices Kimberly-Clark Corporation Class II Terminated Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA Details
Devices DeRoyal Industries Inc Class II Ongoing Nationwide Distribution including SD and NE. Details
Devices Integra Limited Class II Ongoing USA (nationwide) including the states of AZ, CA, IL, MA, MN, NJ, OK, TN, TX, VA, WA and WI. Details
Food Standard Process, Inc. Class I Ongoing AL, AZ, AR, CA,CO, CT, DE, DC, FL,GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NY, NH,NM, NY, NC, OH, OK, PA, RI,SC, TN,TX,VT, VA, WA, WV, WI. Details
Drugs Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals Class III Ongoing Nationwide Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution (USA) nationwide Details
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