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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics American Red Cross Blood Services Class III Terminated Connecticut Details
Biologics American National Red Cross (The) Class II Terminated PR, MO, PA Details
Biologics American Red Cross Blood Services Class II Terminated TN, MO, IL Details
Biologics American Red Cross Blood Services Class II Terminated PR and MO Details
Biologics American National Red Cross (The) Class III Terminated New York Details
Biologics American National Red Cross (The) Class II Terminated New York Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Biologics ZLB Bioplasma, Inc. Class II Terminated Germany Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Biologics DCI Biologicals Wilmington, Inc. Class II Terminated PA & England Details
Biologics American Red Cross Blood Services Class II,Class III Terminated TN, CA Details
Biologics CSL Plasma, Inc Class II Terminated IL, NC, Switzerland & Germany Details
Biologics Community Blood Center Of Gtr KC Class III Terminated Kansas Details
Biologics American Red Cross Blood Services Class II Terminated KS, TX Details
Biologics American Red Cross Blood Services Class II,Class III Terminated KS, CA Details
Biologics American National Red Cross (The) Class III Terminated CT, NY Details
Devices Dako North America Inc. Class II Terminated Nationwide distribution: USA including states of: AK, CA, CO, CT, DC, FL, GA, HI, IA, IL IN, KS, KY, MA, MD, MI, MN, MO, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, and WA. Details
Biologics Csl Plasma Inc Class II Terminated Illinois, Switzerland, Germany Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY; and countries of: ARGENTINA, AUSTRALIA, BANGLADESH, BRAZIL, CALI COLOMBIA, CALLO PERU, GERMANY, GUAYQUIL ECUADOR, HONG KONG, INDIA, INDONESIA, JAPAN, LEBANON, MADRID SPAIN, MEXICO, NEW ZEALAND, SANTIAGO, SANTIAGO CHILE, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SRI LANKA, TAIWAN, THAILAND, and UNITED ARAB EMIRATES (UAE). Details
Biologics Medical Information Technology, Inc. Class II Ongoing Nationwide Canada Details
Biologics American National Red Cross (The) Class II Terminated Nevada; California Details
Drugs Stat Rx USA Class III Completed FL, PA, and VA. Details
Biologics Amer. National Red Cross-Greater Chesapeake & Potomac Reg. Class II Terminated Maryland Details
Biologics The American National Red Cross - Southern Region Class III Terminated Georgia Details
Biologics American National Red Cross The Class II Terminated California Details
Biologics Medical Information Technology, Inc. Class II Ongoing Nationwide Foreign: Canada, UK, Virgin Islands Details
Biologics DCI Donor Services Tissue Services Division Class II Terminated New Mexico; California Details
Devices Stryker Howmedica Osteonics Corp. Class II Ongoing Worldwide Distribution - US Nationwide and countries of: Canada, Chile, Sweden and United Kingdom Details
Food McCormick & Company, Inc. Class II Ongoing Products were shipped nationwide Details
Biologics One Lambda Inc Class III Terminated US, Canada, Saudi Arabia, Brazil, China, Japan, Mexico, New Zealand, Puerto Rico, Singapore, Taiwan, and Thailand. Details
Biologics Community Blood Centers of Florida, Inc. Class III Terminated FL Details
Food RDK Corp Class II Ongoing Distribution was made to fund-raising organizations located in AZ, IL, and WI. There was no foreign, military, or government distribution. Details
Biologics Florida Lions Eye Bank, Inc. Class III Terminated Florida; Dominican Republic Details
Food FreshPoint South Florida Class I Ongoing FL, NJ and US Virgin Islands Barbados, St. Kitts, Dutch Antilles and Aruba Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI Details
Biologics Surgical Biologics LLC Class II Terminated Louisiana Details
Food American Licorice Co Class II Ongoing Nationwide distribution. Details
Food Taco Loco Products Inc Class II Completed Product distributed to retail stores in Alaska only Details
Drugs ITW Dymon Class III Ongoing Nationwide Details
Food Super Store Industries Class I Ongoing Albertsons retail stores in OR, UT, WA, ID, MT and Walmart stores in WA only. Details
Devices Progressive Medical Inc Class II Terminated USA (nationwide) including the states of CO, IN, KS, MA, MN, MO, NE, OH, SC, TN, TX, VA, and WI. Details
Devices Synthes USA HQ, Inc. Class II Ongoing Nationwide Distribution-including the states of CA, MN, NC, and TN. Details
Food Advance Pierre N Class I Ongoing U.S. Nationwide Details
Food Sconza Candy Company, Inc. Class I Ongoing Product was only sold to one customer, Chris Candies, 1557 Spring Garden Avenue Pittsburg, PA 15212 Details
Devices Zimmer, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally to Belgium, Czech Republic, Egypt, France, Germany, Morocco, Netherlands, Romania, Saudi Arabia, Spain, Switzerland, Turkey, and UAE. Details
Food Whole Foods Market Group Inc. Class II Terminated Massachusetts, Connecticut, New York and New Jersey Details
Biologics Oklahoma Lions Eye Bank Class II Terminated Oklahoma; Egypt Details
Food Bucks Ice Cream Class I Ongoing CT, NY and NJ Details
Food Kennys Farmhouse Cheese Class I Ongoing KY, TN, FL, IL, VA, OH Details
Food Dean Foods Company Class I Ongoing Sold by retailers in AZ, CA, CO, ID, MT, ND, NV, OR, UT, WA, and WY. Details
Food Toft Dairy Inc Class I Ongoing 3 Distributors 211 Retailers Details
Food Publix Corporate Office Class I Ongoing Product was distributed to Publix Distribution centers and stores in FL, AL, TN, GA, and SC. Details
Food Paradise Tomato Kitchens Inc Class II Ongoing Various states Details
Drugs New England Compounding Center Class II Ongoing Nationwide Japan Details
Devices Horiba Instruments, Inc dba Horiba Medical Class III Ongoing Nationwide Distribution Details
Food B.T. McElrath Chocolatier, Inc Class I Ongoing MN, CA, FL, WA, IL, AK, MA. Details
Drugs Ameridose LLC Class II Ongoing Nationwide Details
Devices Trivascular, Inc Class II Ongoing Worldwide Distribution - US Nationwide and the countries of Belgium, Cyprus, Italy, Spain, Switzerland and Turkey. TriVascular stated that no purchased devices are in hospital inventory in Europe or the U.S. Details
Biologics One Lambda Inc Class II Ongoing Domestic and international consignees. US Sates nationwide, Canada, Saudi Arabia, UK, France, Germany, Italy, Russia, Sweden, Portugal and Spain, Turkey, Brazil, China, Chile, Japan, and Malaysia. Details
Devices Gulf South Medical Supply Inc Class II Ongoing Nationwide distribution: USA including states of: DE, KY, LA, MD, NJ, NY, PA, TX, VA, and WV. Details
Biologics Bio-Rad Laboratories Class III Ongoing Product was distributed nationwide and to Australia and France. Details
Drugs Stat Rx USA Class III Ongoing GA and TN. Details
Devices MOOG Medical Devices Group Class II Ongoing Worldwide Distribution - USA (nationwide) including the countries of Canada and Lithuania. Details
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