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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics SCC Soft Computer Class II Terminated Product was distributed to 85 consignees within the United States and 2 Canadian consignees. Details
Biologics Community Blood Center Class II Terminated IN, OH Details
Biologics Community Blood Center Class II Terminated Ohio Details
Biologics Community Blood Center Class II Terminated Ohio, Switzerland Details
Biologics Community Blood Center Class II Terminated Ohio Details
Biologics Community Blood Center Class II Terminated Ohio Details
Biologics American Red Cross Blood Services Class III Terminated MO Details
Biologics American Red Cross Blood Services Class II Terminated KS Details
Biologics Biomat USA, Inc. Class II Terminated Spain Details
Biologics American Red Cross Blood Services Class II Terminated TX, CA Details
Biologics CSL Plasma Class III Terminated IL, Germany Details
Biologics CSL Plasma Inc Class II Terminated Germany, Switzerland, IL, NC Details
Biologics Hoxworth Blood Center University of Cincinnati Medical Center Class III Terminated OH Details
Biologics Bio-Blood Components, Inc. Class III Terminated CA Details
Biologics American National Red Cross (The) Class III Terminated OH Details
Biologics American Red Cross Blood Services Class II,Class III Terminated TX, CA Details
Biologics American Red Cross Blood Services Class III Terminated KS, OK Details
Biologics Talecris Plasma Resources, Inc. Class III Terminated North Carolina Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated North Carolina Details
Biologics Csl Plasma Inc Class II Terminated IL Details
Biologics Csl Plasma Inc Class II Terminated IL Details
Biologics Csl Plasma Inc Class II Terminated IL Details
Devices Steris Corporation Class II Completed Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico and the following countries: American Samoa, Argentina, Australia, Bahrain, Bangladesh, Bermuda, Brazil, Canada, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Germany, Greece, Guam, Hong Kong, India, Indonesia, Israel, Italy, Japa, Jordan, Kazakhstan, Korea, Kuwait, Lebanon , Libya , Malaysia , Mexico, Morocco, New Zealand, Panama, Peru, Philippines , Poland, Portugal, Qatar, Russia, Saudi Arabia , Singapore, South Africa, Spain, Sri Lanka, Taiwan, Thailand, Trinidad and Tobago, Turkey & United Kingdom. Details
Biologics Upstate New York Transplant Services, Inc. Class II Terminated Alabama, Venezuela Details
Food Hocean Inc Class I Completed Distributed to wholesale distributors and Asian grocery stores nationwide to US states: California, Texas, Oregon, Nebraska, Georgia, Florida, Colorado, Oklahoma, Washington, New Mexico, Ohio, Arizona, Tennessee, North Carolina, and Virginia. Details
Biologics Blood Centers of the Pacific - Irwin Center Class II,Class III Terminated Switzerland; Austria; California Details
Devices Custom Medical Specialties, Inc. Class I Completed US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA. Details
Biologics Blood Systems, Inc Class II Terminated Products were distributed to four domestic consignees including blood bank and health care facilities, located in Montana State. One of the four consignees responded that the unit was transfused. Details
Drugs Dukal Corp. Class II Ongoing Nationwide Details
Biologics The Blood Connection, Inc. Class III Terminated Michigan, South Carolina Details
Biologics Blood Assurance Inc Class II,Class III Terminated Tennessee, Georgia, Indiana Details
Biologics Memorial Blood Centers Class II Terminated Minnesota Details
Biologics HCSC-Blood Center Class II Terminated Pennsylvania Details
Biologics HCSC-Blood Center Class II,Class III Terminated Pennsylvania, Korea, New Jersey Details
Biologics Amer. National Red Cross-Greater Chesapeake & Potomac Reg. Class III Terminated Maryland Details
Biologics American Red Cross Blood Services Class III Terminated California Details
Devices Biomet, Inc. Class II Ongoing Nationwide Distribution-including the states of WA, IN, AK, PA, GA, SD, KS, NY, VA, AR, AL, OH, WI, MA, and CA. Details
Biologics American National Red Cross Class II,Class III Terminated Ohio, California Details
Drugs Hospira Inc. Class II Ongoing Nationwide, including Puerto Rico and Guam. Product was also distributed internationally to Australia, Belgium, Canada, France, Germany, Korea, Malaysia, New Zealand, Norway, Pakistan, Philippines, Portugal, Singapore, Sweden, Thailand and Vietnam Details
Biologics Life Technologies, Inc. Class II Ongoing Nationwide and CANADA Details
Devices BD Biosciences, Systems & Reagents Class II Ongoing Worldwide Distribution -- USA (nationwide) including the countries of Australia, Belgium, Canada, Chile, Korea, Mexico, Singapore and Taiwan. Details
Food Atico International USA, Inc. Class II Ongoing Milwaukee, WI Details
Devices Kimberly-Clark Corporation Class III Completed US (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA. Details
Devices Impact Instrumentation, Inc. Class III Completed Nationwide distribution: USA including states of: FL and OH. Details
Food San Francisco Herb & Natural Food Company Class II Ongoing Nationwide and Canada. Details
Devices Roche Molecular Systems, Inc. Class II Ongoing Nationwide (USA) Distribution Details
Devices DePuy Orthopaedics, Inc. Class II Ongoing Nationwide Distribution including the states of MA, TX, OH, CA, and NC. Details
Food GMP Laboratories of America Inc Class II Terminated US States nationwide. Details
Food Vaqueria Tres Monjitas, Inc. Class I Ongoing PR only Details
Food Singh And Singh Distributors Inc. Class I Ongoing New Jersey and New York Details
Food Indian Foods & Spices, LLC Class I Ongoing New Jersey, New York and Pennsylvania. Details
Devices Bio-Rad Laboratories Class II Ongoing Worldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe. Details
Devices Covidien LLC Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Israel, Jordan, Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Venezuela and UK. Details
Food R & S Mexican Food Products, Inc Class II Terminated 4 direct accounts in AZ. No international or outside states. Details
Devices Philips Healthcare Inc. Class II Ongoing Worldwide Distribution - USA including OH and WA and the country of Canada Details
Devices Instrumentation Laboratory Co. Class II Ongoing Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF LUXEMBOURG, MACAU, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SLOVAKIA (Slovak Republic), SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED KINGDOM, URUGUAY and VIETNAM. Details
Devices Siemens Healthcare Diagnostics, Inc Class III Ongoing Worldwide Distribution - US Nationwide and the countries of: Canada, Argentina, Australia, Bangaldesh,Brazil, Chile, China, Columbia, Croatia, Ecuduar, Egypt, Hong Kong, India, Israel,Japan, Korea, Maylasia, New Zealand, Mexico, Peru, Philipines, Pakistan, Saudia Arabia, Singapore, Thailand, Taiwan, Viet Nam, South Africa and UK. Details
Devices Tedan Surgical Innovations Llc Class II Ongoing Worldwide distribution: USA (nationwide) and countries of : Australia and Taiwan. Details
Devices Elekta, Inc. Class II Ongoing Nationwide Distribution including AL, AZ, CA, CO, CT, FL, GA, IL, IA, MD, MA, MI, MN, NE, NV, NJ, NM, NY, ND, OH, OK, OR, PA, VA, SC, TN TX, WA, WV, WI and Puerto Details
Devices Zoe Medical Incorporated Class II Terminated Nationwide distribution: WA only. Details
Food Protica, Inc Class II Ongoing Nationwide distribution - product was distributed to direct accounts in AL, AZ, FL, IL, IN, KY, MN, MO, MS, NY OH, OK, RI, SC, TX and VA. Details
Food Chamberlain Farms Inc. Class I Ongoing Indiana, Kentucky, Missouri, Illinois, and Iowa with further shipment including Tennessee, Ohio, and Wisconsin. Counties involved include Vanderburgh, Warrick, Gibson, and Dubois County, Indiana, and Wabash County,Illinois. Details
Drugs Carefusion 213, Llc Class II Completed Nationwide Details
Food Spence & Co., Ltd. Class I Ongoing CO, FL, NC, GA, DE, PA, MD, NJ,NY, VA, OH, NV, OK, WY, KY, TN, CO. Details
Devices Integra LifeSciences Corporation Class II Ongoing Worldwide distribution: USA (Nationwide) and countries of: Argentina, Australia, Belgium, Canada, China, Czec, Denmark, France, Hong Kong, Hungary, Italy, Japan, Malaysia, Philippines, Singapore, Spain, South Africa, and UK. Details
Food Tunnel Farms Class II Ongoing NC Details
Food American Licorice Co Class II Ongoing Nationwide distribution. Details
Food Friendly Ice Cream Corp. Class II Ongoing Maine, New Hampshire, Vermont, Connecticut, Massachusetts, Rhode Island, New York, New Jersey, Pennsylvania, Delaware, Maryland, Virginia, Florida Details
Devices Kimberly-Clark Corporation Class II Completed Nationwide Distribution including AL, AK, AZ, CA, CO, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, ME, MA, MI, MN, MS, MO, NE, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI. Details
Devices ZOLL Medical Corporation Class II Terminated Worldwide Distribution - US Nationwide including the states of: LA, MA, ME, NC, ND, NE, OH and the country of Germany. Details
Devices Philips Medical Systems (Cleveland) Inc Class III Ongoing Worldwide Distribution - US Nationwide including the states of: AL, CA, GA, MA, MD, NC, OH, PA, TX, and WA; and to the following countries of: Algeria, Oman, Australia, Brazil, China, Saudi Arabia, United Arab Emirates, and India. Details
Devices Spacelabs Healthcare, Llc Class II Ongoing Worldwide Distribution. Details
Devices Haag-Streit USA Inc Class II Ongoing Worldwide distribution: USA (nationwide) including states of: AR, CA, CT, FL, GA, IA, IL, LA, MA, MI, MN, MS, NJ, NV, NY, OH, OR, PA, SC, SD, WA, WI, and WV; and to the countries of Jamaica, Puerto Rico, and Mexico. Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide distribution, Nationwide (US) including the states AL, AR, CA, FL, GA, IL, IN, MS, NJ, NV, NY, OH, PA, and VA and the countries of Albania, Argentina, Australia, Belgium, Brazil, Chile, China, Colombia, Dominican Republic, Ecuador, France, Germany, Greece, India, Indonesia, Ireland, Italy, Jordan, Lebanon, Malawi, Mexico, Nepal, Netherlands, Oman, Palestine, Philippines, Poland, Romania, Russia, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Turkey, Uganda, and Venezuela. Details
Devices Sekisui Diagnostics Llc Class II Ongoing Nationwide distribution: USA including states of: FL, IN, IL, and WA. Details
Devices Varian Medical Systems, Inc. Oncology Systems Class II Ongoing Worldwide Distribution. Details
Food Triple B Corporation - Charlie's Produce Class I Ongoing Distributed in Alaska and Washington. Details
Food World Food LLC. Class I Ongoing Products were distributed in FL only. Details
Food F & S Produce Co., Inc. (Site II) Class I Ongoing CT, DE, MA, MD, ME, NH, NJ, NY, PA, RI, VA, FL and Washington D.C. Details
Devices Davol, Inc., Subs. C. R. Bard, Inc. Class II Ongoing Nationwide Distribution. Details
Food Somersault Snack Co., LLC Class I Ongoing CA, NH, NV, RI, MD, PA, TN, FL, CT. WA, TX, NJ, MN, IN, GA. Details
Devices Hospira Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of Saudi Arabia, Canada and Barbados. Details
Drugs Apace KY LLC Class III Ongoing Nationwide Details
Devices Smith & Nephew Inc Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of CA, FL, GA, IL, IN, MA, NC, NJ, NY, OH, OK, PA, TN, TX, and WA, and the country of Canada. Details
Devices Vascular Solutions, Inc. Class II Ongoing Worldwide distribution: USA (nationwide) including states of: AZ, AR, CA, CT, DE, FL, GA, ID, IL IN , KY, LA,MD, MN, MO, NV, NM, NY, OH, PA, SC, TN, TX, VA, WA, and WV; and countries of: Italy and Korea. Italy, Korea Details
Devices Amsino Medical USA Class III Ongoing Distributed to one customer in Illinois. Details
Devices RAYSEARCH LABORATORIES AB Class II Completed Worldwide Distribution - USA including CA, KY, MI, NY, OK, and OR. Internationally to Canada, Belgium, United Kingdom, Australia, France, Germany, and Poland. Details
Devices Steris Corporation Class II Ongoing Worldwide Distribution--USA (nationwide) including the states of AL, CA, CO, CT, FL, GA, IA, IN, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK,OR, PA, RI, SC, TX, UT, VA, WA, WI, WV and WY. and the country of Canada. Details
Devices Steris Corporation Class II Ongoing Worldwide Distribution - US Nationwide including the states of: AL, AR, CA, CO, CT, FL, HI, ID, IL, IN, IA, KY, LA, MA, MD, ME, MI, MN, MO, MS, NV, NYH, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WI & WV and countries of: Australia, Canada, China, India, Korea, Mexico, Panama and Thailand. Details
Devices Asahi Kasei Medical Co., Ltd., Okatomi Plant Class II Ongoing REXEED SX: Worldwide Distribution - USA including TN and the countries of Japan and Germany REXEED LX: Worldwide Distribution - USA including TN and Germany Details
Drugs Sandoz Incorporated Class III Ongoing Nationwide Details
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