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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Community Blood Center of Greater Kansas City Class II Terminated MO Details
Biologics Community Blood Center of Greater Kansas City Class III Terminated MO Details
Biologics Community Blood Center of Greater Kansas City Class III Terminated MO Details
Biologics Community Blood Center of Greater Kansas City Class III Terminated MO Details
Biologics Community Blood Center of Greater Kansas City Class II Terminated MO Details
Biologics Community Blood Center of Greater Kansas City Class II Terminated , MO Details
Biologics CSL Plasma Inc Class II Terminated IL, NC Details
Biologics American National Red Cross (The) Class II Terminated OH Details
Biologics ZLB Bioplasma, Inc. Class II Terminated IL Details
Biologics American National Red Cross (The) Class II Terminated KY, OH, IN Details
Biologics American National Red Cross (The) Class II Terminated KY Details
Biologics Community Blood Center Class II Terminated OH Details
Biologics Hoxworth Blood Center University of Cincinnati Medical Center Class II Terminated OH and KY Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated NC Details
Food Designer Protein LLC Class II Ongoing nationwide in the US and worldwide to Philippines and Brazil. Details
Food Southwind Foods LLC dba Great American Seafood Imports Co. Class II Ongoing Nationwide Details
Biologics Interstate Blood Bank Inc Class II Terminated CA Details
Biologics CSL Plasma, Inc. Class II Terminated IL, Switzerland, Germany, North Carolina Details
Food Gills Onions, LLC Class I Ongoing Nationwide in the US and to Canada Details
Veterinary Central Garden & Pet Company Class I Ongoing Nationwide including Puerto Rico. OUS to include: Australia, Canada, China, Dominican Republic, Guam, Hong Kong, Japan, Korea, Mexico, New Zealand, South Africa, and Thailand. Details
Veterinary Land O Lakes Purina LLC Class I Terminated The feed was distributed in IA. Details
Drugs Hospira Inc. Class I Ongoing Nationwide. Details
Food River Ranch Fresh Foods LLC Class I,Class II Ongoing Products were released for distribution in US and Canada. Details
Biologics Blood Assurance Inc Class II Terminated TN, GA, NY Details
Biologics Blood Assurance Inc Class II,Class III Terminated GA, IN Details
Biologics Central California Blood Center Class II Terminated CA Details
Biologics Plasmacare Inc Class III Terminated CA Details
Biologics LifeServe Blood Center Class II Terminated IA and FL Details
Biologics American National Red Cross (The) - North Central Region Class II Terminated MN Details
Devices SCC Soft Computer Class II Ongoing US Nationwide Distribution Details
Biologics So Ca Permamente Med Group Blood Donor Cntr Class II Terminated CA Details
Biologics Florida's Blood Centers, Inc. Class II Terminated FL Details
Food Altura Food, Inc. Class I Ongoing Puerto Rico- Only one consignee Details
Drugs Teva Pharmaceuticals USA, Inc. Class II Ongoing Nationwide 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 Interstate Blood Bank, Inc. WI Class III Terminated CA Details
Biologics Plasma Biological Services, Inc Class II Terminated NC Details
Biologics Blood Center of Northcentral Wisconsin, Inc. Class II Terminated WI Details
Biologics Walter L. Shepeard Community Blood Center, Inc. Class II Terminated GA Details
Devices Angiodynamics Worldwide Headquarters Class II Ongoing Worldwide distribution: USA (nationwide) including states of: CA, KS, MO, and NC and countries of: Czech Republic and Switzerland. Details
Biologics New York Blood Center, Inc. Class II Terminated New York Details
Biologics Florida's Blood Centers, Inc. Class III Terminated Florida Details
Biologics Talecris Plasma Resources, Inc. Class III Terminated North Carolina Details
Biologics Memorial Blood Centers Class III Terminated Minnesota Details
Biologics Memorial Blood Centers Class II Terminated Minnesota Details
Devices Biomet 3i, LLC Class II Ongoing Worldwide Distribution -- United States, UK, France, Canada, Mexico, Poland, Lebanon and Hong Kong. Details
Devices Linvatec Corp. dba ConMed Linvatec Class II Ongoing Nationwide Distribution, including the states of Colorado and Pennsylvania. Details
Devices Siemens Healthcare Diagnostics, Inc. Class II Ongoing USA (nationwide) including the states of AZ, CA, MS, MO, NJ, NC, OH, OR, PA, and TX. Details
Biologics South Texas Blood & Tissue Center Class II Terminated Austria, Florida, Texas Details
Devices GE OEC Medical Systems, Inc Class I Completed Worldwide Distribution - USA including MO, IL, LA, FL, NH, TX, IN, PA, NJ and the countries of France and China Details
Devices Stryker Spine Class II Ongoing Nationwide Distribution including NC, AR, TN, MA, IL, GA, NY, LA, MN, MO, OH, KS, NM, TX, KS,and IN. Details
Drugs Apotex Corp. Class II Ongoing Nationwide Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Japan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam. Details
Devices Siemens Healthcare Diagnostics, Inc. Class II Ongoing Worldwide distribution, including the countries of Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, New Zealand, Slovakia, Spain, Switzerland and the United States, with nationwide distribution. Center Recall Depth is Retail. Details
Devices Roche Molecular Systems, Inc. Class III Ongoing Worldwide Distribution - including the countries of Austria, Belgium, Czech Republic, Denmark, Germany, Italy, Luxemburg, Netherlands, Poland, Slovakia, Slovenia, Spain, United Kingdom, Canada, Chile, Greenland, Hong Kong, Israel, Malaysia, New Zealand, Philippines, S. Africa, Switzerland, Taiwan and Turkey. Details
Devices Tango3 LLC Class II Ongoing Product was shipped to the following states: CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, NH, NJ, NM, OH, PA, RI, TX and VA. Details
Devices Smith & Nephew, Inc. Endoscopy Division Class II Ongoing Worldwide Distribution - US Nationwide and the countries of: Argentina, AUSTRALIA, AUSTRIA, Belgium, CANADA,CHILE COLOMBIA, Denmark, DUBAI, FINLAND, FRANCE GDC BAAR Distribution,GERMANY, GREECE, INDIA ITALY, KOREA, MALAYSIA, MEXICO, NETHERLAND, NORWAY PORTUGAL, PUERTO RICO, SHANGHAI, SOUTH AFRICA SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM. Details
Devices Abbott Point Of Care Inc. Class II Ongoing Worldwide Distribution - USA including AZ and CO and internationally to Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Chile, China, Columbia, Costa Rica, Dominican Republic, El Salvador, Finland, France, Georgia, Germany, Greece, Honduras, Hong Kong, India, Ireland, Italy, Korea, Kuwait, Mauritius, Mexico, Netherland (Antilles), Nigeria, Norway, Oman, Paraquay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, R.O.C., Thailand, UAE, United Kingdom, and Yemen. Details
Devices Impact Instrumentation, Inc. Class III Ongoing US Distribution to the state of Illinois. Details
Devices Abbott Point Of Care Inc. Class II Ongoing Worldwide Distribution -- (USA) nationwide Details
Food Two Chefs On A Roll, Inc Class II Ongoing Product is manufactured for and distributed to Maya Kaimal Fine Indian Foods, 4755 27th Street, Long Island City, NY (PO Box 700, Rhinebeck, NY 12572). Secondary distribution to accounts in CT, MA, ME, NH, NJ, NY, RI and VT. Details
Devices Philips Healthcare Inc. Class II Ongoing Worldwide Distribution - US (nationwide) including the states of CA, CT, MI, MN, MN, NC, NY, NY, VA and the countries of Belgium, Columbia, Czech Republic and Denmark. France Germany Italy Latvia Luxembourg Netherlands Russian Fed. Spain Sweden Switzerland Thailand United Kingdom Details
Devices FMS, Finapres Medical Systems BV Class II Ongoing US Nationwide Distribution - including the states of: OH and NY Details
Devices Baxter Healthcare Corp. Class I Ongoing Worldwide Distribution - USA - Nationwide including Puerto Rico, and internationally to Brazil, Canada, Colombia, Costa Rica, Czech Republic, El Salvador, Egypt, Germany, Guatemala, Honduras, Luxembourg, Mexico, Panama, Saudi Arabia, Singapore, Switzerland, Taiwan, Trinidad, Turkey, United Arab Emirates and United Kingdom. Details
Devices Encore Medical, Lp Class II Ongoing Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT. Details
Devices Varian Medical Systems, Inc. Oncology Systems Class II Ongoing Nationwide Distribution including the states of New York and Ohio. Details
Devices Straumann USA, LLC Class II Ongoing US Nationwide Distribution including the countries of FL, IN, LA, NY and TX. Details
Devices Transenterix, Inc Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of Austria, Germany, Italy, Qatar and Switzerland Details
Devices Greiner Bio-One North America, Inc. Class II Ongoing Nationwide Distribution Details
Devices Kimberly-Clark Corporation Class II Ongoing Nationwide Distribution-including the states of AZ, CA, CO, DE, FL, GA, IA, ID, IN, IL, KS, KY, LA, MA, MD, ME, MO, MS, NE, NM, OH, OR, PA, RI, SC, TN, TX, VA, WI and WV. Details
Drugs Nephron Pharmaceuticals Corp. Class II Ongoing Nationwide and Puerto Rico Details
Devices Siemens Healthcare Diagnostics, Inc. Class III Ongoing Worldwide Distribution -- US, including Washington, DC and the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WV, and the countries of Canada, New Zealand, Germany, and Puerto Rico. Details
Devices Siemens Healthcare Diagnostics, Inc. Class II Ongoing Distributed in the US including Washington, DC, 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, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WI, WV, and WY and the Virgin and Pacific Islands. Details
Food Pal-Do Company, Inc d.b.a. Pal-Do World Class II Ongoing Product was distributed to one consignee in Lakewood, WA. Details
Devices Smith & Nephew, Inc. Endoscopy Division Class II Ongoing Worldwide Distribution - US Nationwide and the countries of : Australia, Canada, Korea, Turkey, UAE, and Japan. Details
Devices Stryker Spine Class II Ongoing Worldwide Distribution -- US, Switzerland, Netherlands, Brazil, Hong Kong, Germany, and Taiwan. Details
Food Naturex Inc. Class III Ongoing 1 firm in New Jersey and 1 firm in South Carolina Details
Devices Linvatec Corp. dba ConMed Linvatec Class II Completed Worldwide Distribution -- US and Korea. Details
Food Shah Distributors Class I Ongoing Northern CA only. Details
Food Mount Franklin Foods LLC Class I Ongoing AZ, CA, KY, OK, and VA. Details
Food GH Foods CA LLC Class I,Class II Ongoing CA, NV, AZ, UT, AZ, CO, NM, SD, WY, NE. Details
Food Ken's Foods, Inc. Class I Ongoing AL,FL,GA,IL,KY,MS,NC,NE,NM,NV,OH,OK,SC,TN,TX,WI Details
Devices Berchtold Corp. Class III Ongoing Nationwide Distribution including FL, MI, MS, and NH. Details
Food Fahman Enterprises, Inc Class I Ongoing Products were distributed to the states of Texas, Kansas, and Arkansas Details
Drugs Oklahoma Respiratory Care Inc Class II Completed OK Details
Food FreshPoint Central Florida Class I Ongoing Onion products were distributed to restaurant/food service in FL only. Details
Food High Liner Foods Inc. Class II Terminated Nationwide Details
Food San Miguel Produce, Inc. Class I Ongoing Distributed to AZ, CA, IA, and NV. Details
Food Nuts and Spice Co., Inc. Class I Ongoing Northern CA, and one customer in WA, NV, UT. Details
Devices Medical Specialties Distributors, Inc. Class II Ongoing Nationwide Distribution Details
Food FreshPoint South Florida Class I Ongoing Products were distributed in South Florida. Details
Food Keys Fisheries, Inc. Class I Ongoing Product was distributed to Whole Food Stores in Florida. Details
Food SJBW Corp Class II Terminated CA, NV, GA, WA Details
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