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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics American Red Cross Blood Services Class II Terminated MO Details
Biologics American National Red Cross (The) Class III Terminated IL Details
Devices NuVasive Inc Class II Terminated Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Details
Biologics CSL Plasma, Inc. Class II Terminated NC, IN Details
Biologics Community Blood Center of Carolinas Class III Terminated NC Details
Food Postres de Aqui, Inc. Class II,Class III Ongoing PR Only. Details
Drugs Church & Dwight Inc Class II Ongoing Nationwide Details
Food Sartori Inspirations, LLC Class I,Class II Ongoing Distributed to Whole Foods Grocery chain only with nationwide locations including Rocky Mountain, Northeast, North Atlantic, Mid Atlantic, Northwest, and Southwest. Details
Devices KCI USA, Inc. Class II Ongoing Nationwide Distribution including AL, CA, CO, OK and GA. Details
Devices Stryker Orthobiologics, Inc. Class II Ongoing Nationwide Distribution-including the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV Details
Devices Siemens Healthcare Diagnostics, Inc. Class II Ongoing USA (nationwide) including the states of AL, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and WI. Details
Devices Extremity Medical LLC Class II Ongoing Worldwide Distribution-USA (nationwide) including the states FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE, and the country of Switzerland. Details
Devices Microgenics Corporation Class III Ongoing Worldwide Distribution--USA (nationwide) and the countries of Germany, Canada and Australia. Details
Veterinary Dairy Farmers Of America, Inc. Class I Ongoing Goshen, IN, Hillsboro, WI, and Reedsburg, WI. Details
Devices Zimmer, Inc. Class II Ongoing Worldwide distribution: USA (nationwide) and countries of: Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America. Details
Devices SpineFrontier, Inc. Class II Ongoing US Nationwide including the states of: MA and TX. Details
Devices Linvatec Corp. dba ConMed Linvatec Class II Ongoing Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania. Details
Devices Zimmer, Inc. Class II Ongoing Worldwide Distribution - USA nationwide including the states of: AK, CA, IL, FL, HI, MI, MO, NC, NJ, NY, OH, PA, TX and the countries of Germany, Brazil, Canada, Japan, Taiwan, Thailand, India and Korea. Details
Devices Zimmer, Inc. Class II Ongoing USA (nationwide) including the states of Ohio, Carolinas and New England. Details
Veterinary Quality Feed, Inc Class I Ongoing IL, MN, IN, NY, OH, PA, WI Details
Drugs Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals Class I Ongoing Nationwide. Details
Devices SpineFrontier, Inc. Class II Completed Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico. Details
Biologics Blood Systems, Inc. Class II Terminated NV Details
Biologics Florida's Blood Centers, Inc. Class III Terminated FL Details
Biologics DCI Biologicals LLC Class II Terminated United Kingdom Details
Biologics Puget Sound Blood Center and Program Class II Terminated NJ Details
Biologics Community Blood Center Class II,Class III Terminated OH and IN Details
Biologics Stanford Medical School Blood Center Class II Terminated CA and IN Details
Biologics Blood Systems Inc Class II Terminated AZ Details
Biologics Tri-counties Blood Bank Class II Terminated AZ Details
Drugs Watson Laboratories Inc Class I Ongoing Nationwide Details
Biologics BloodCenter of Wisconsin, Inc Class III Terminated WI Details
Biologics Memorial Blood Centers Class II Terminated WI, NY, MN Details
Biologics Blood Systems, Inc Class II Terminated TX Details
Devices Mindray DS USA, Inc. d.b.a. Mindray North America Class I Ongoing Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Chile, Colombia, and Venezuela. Details
Devices Ethicon, Inc. Class I Ongoing Worldwide Distribution - USA (nationwide) and the countries of Russia, China, and the European Union. Details
Biologics Arc Blood Services, New England Region Class III Terminated Massachusetts; New York Details
Biologics Inland Northwest Blood Center Class II Terminated Washington Details
Devices Stryker Howmedica Osteonics Corp. Class II Ongoing Worldwide distribution: USA (nationwide) and countries including: Canada, Belgium, Finland, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Poland, Portugal, Spain, Turkey and UK. Details
Devices Stryker Spine Class II Ongoing Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom. Details
Devices Biomerieux Inc Class II Ongoing Worldwide Distribution - USA including AR, AZ, CA, FL, KS, LA, MD, MN, MT, NC, NV, NY, OR, PA, RI, SC, TX, VA and WA. Internationally to Argentina, Armenia, Austria, Bangladesh, Bosnia and Herzegowina, Brazil, Bulgaria, Burkina FASO, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, COTE DIVOIRE, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA, MALTA, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, UNITED STATES, URUGUAY, VENEZUELA, VIETNAM, PALESTINE, AND SERBIA. Details
Devices Biomerieux Inc Class II Ongoing Worldwide Distribution - USA (nationwide) including the states of: AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, TN, TX, VA and WI. Distribution was also made to Canada, military facilities and other foriegn countries. Details
Devices Vital Signs Devices, a GE Healthcare Company Class II Ongoing Worldwide distribution: USA (nationwide) including states: AZ, CA, CT, FL, GA, IL, KS, KY, MA, MD, MN, MO, NJ, NM, NY, OH, PA, SC,TX, WA, and WY; and countries of: Australia and Canada. Details
Food The Dannon Company Inc Class II Ongoing 21 US states and Puerto Rico Details
Food Gilster-Mary Lee Corp. Class I Ongoing Distribution was made to two distribution centers one in TX and one in NC. Further distribution to retail stores was made to SC, GA, FL, TN, VA, WV, KY, OH and PA. Details
Devices Innovative Magnetic Resonance Imaging Systems Inc. Class II Ongoing Nationwide Distribution, including the states of FL, GA, IN, MD,MA, MI, MN, MO, TN, UT, and VA. Details
Food Torn & Glasser Inc. Class I Ongoing US states: CA, AZ, NV, TX, CO, ID, MO, NJ, NM, OK, UT. No international consignees. Details
Devices Spacelabs Healthcare, Llc Class II Ongoing Worldwide Distribution. Details
Devices Beckman Coulter Inc. Class II Terminated Worldwide Distribution - USA (nationwide) and Internationally to Canada, AE, AU, BG, BW, CH, CN, CZ, DE, ES, FR, GB, HK, HR, HU, IN, IT, JO, JP, LB, MA, MX, NL, PL, QA, RO, RU, SK, TN, TR, ZA, AO, AR, AT, BE, CO, DZ, FI, IE, IL, KR, KW, LI, NA, NO, NZ, PF, PH, PR, SE, SG, SZ, TH, TW, VE, VN, and YT. Details
Devices Kerr Corporation Class II Terminated Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, and Europe. Details
Devices Kerr Corporation Class II Terminated Worldwide Distribution--USA (nationwide) and the countries of Canada and EU. Details
Food Charter Baking Company Class II Ongoing Nationally and global including Cuba and Puerto Rico. Details
Drugs Dr. Reddy's Laboratories, Inc. Class II Ongoing Nationwide. No foreign consignees. Details
Devices Vital Signs Colorado Inc. Class II Ongoing Worldwide distribution: USA (nationwide) including states of: AR, CA, FL,GA, IL, LA, MA, MI, MO, NC, NH, NY, OH, OK, PA, RI, SE,TX, and WA; and countries of: AUSTRALIA, BARCELONA, GERMANY, NEW ZEALAND, NETHERLANDS, SWITZERLAND, and UNITED KINGDOM. Details
Devices Horiba Instruments, Inc dba Horiba Medical Class III Ongoing Nationwide Distribution Details
Devices Zimmer, Inc. Class II Ongoing Worldwide Distribution--USA (nationwide) including the states of AL, CA, CT, KS, MA, MD, MN, MO, NY, SD, TX and WI and the countries of Bulgaria,Canada, Germany, Italy, Netherlands, Russian Fed, Sweden and UK Details
Food Swanson Health Products, Inc Class III Ongoing All states except Vermont and Wyoming plus Washington, DC and Puerto Rico; Canada was the only other country. Details
Drugs American Enterprises LLC dba Sterling Gelatin Class II Ongoing NJ Details
Devices OrthoPediatrics Corp Class II Ongoing Nationwide Distribution-including the states of OH, NC, CO, FL, IN, MI, and TX. Details
Devices Kerr Corporation Class II Ongoing Worldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees . Details
Devices King Systems Corp. Class II Ongoing US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC Details
Devices Superstat Corp Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, Thailand, Mexico, Canada, Pakistan, Israel, Greece, Serbia, Canda, Isle of Man, Nova Scotia, and Singapore. Details
Food Schoep's Ice Cream Co, Inc Class II Ongoing retail stores in KY, TN, and VA only Details
Devices Carl Zeiss Meditec, Inc. Class II Terminated Nationwide Distribution including IL and MD Details
Devices GE Healthcare, LLC Class II Ongoing Nationwide Distribution Details
Devices Mako Surgical Corporation Class II Ongoing Worldwide Distribution - USA including IL, OR, IA, AZ, CA, CO, FL, MS, OK, PA, WV, NC, TX, NY, GA, NJ, OH, WA, VA, MA, MD, WI, MI, NV, MO, AL, UT, RI, AR, LA, ID, IN, and TN and Internationally to Japan, Scotland, Italy, Singapore, Turkey, Hong Kong, and Korea. Details
Food E.D. Produce Class I Ongoing CA Details
Devices Biomet, Inc. Class II Completed Nationwide Distribution including CA, IN, NC, OH, and UT. Details
Devices Biomet 3i, LLC Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of VA, SC, HI, LA, OH, FL, IL, NJ, NC, CA, CT, MI, TN, AK, NH, NY, MA, GA, PA, and KY and the countries of United Kingdom, Spain, Germany, Canada, Japan, Singapore, Taiwan, Israel, Poland, Hong Kong, Ireland, The Netherlands, Austria, and France. Details
Drugs Ranbaxy Inc. Class II Ongoing Nationwide Details
Devices Gyrus Acmi, Incorporated Class II Ongoing Worldwide distribution: USA state of Kansas and country of Korea. Details
Devices Sentec AG Class II Ongoing Distributed only in MO. Details
Devices Captiva Spine, Inc Class II Ongoing Nationwide Distribution (Distributed to one customer located in MN) Details
Food Cracker Industries, LLC Class II Ongoing Shipped to one customer in FL Details
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