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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Missouri Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Illinois Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Tennessee Details
Biologics Mississippi Valley Reg Bld Ctr Class III Terminated New York Details
Biologics Mississippi Valley Reg Bld Ctr Class III Terminated Switzerland Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Iowa Details
Biologics Puget Sound Blood Center and Program Class II Terminated Washington. Details
Biologics American Red Cross Blood Services Class II,Class III Terminated KS and CA Details
Biologics University of Texas Medical Branch at Galveston (The) Class II Terminated TX Details
Biologics BioLife Plasma Services L.P. Class III Terminated CA Details
Biologics American Red Cross Blood Services Class II,Class III Terminated KS and CA Details
Biologics American National Red Cross (The) Class II Terminated MO Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Kansas; Missouri Details
Biologics American Red Cross Blood Services Class II Terminated MO Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Missouri; Kansas Details
Biologics Blood Systems, Inc. Class III Terminated TX Details
Biologics Blood Systems, Inc. Class II Terminated TX Details
Biologics Puget Sound Blood Center and Program Class II Terminated California. Details
Biologics Puget Sound Blood Center and Program Class II Terminated Washington. Details
Biologics Puget Sound Blood Center and Program Class III Terminated Austria. Details
Biologics DCI Biologicals Bryan LLC Class II Terminated UK Details
Biologics Community Blood Center of Greater Kansas City Class II Terminated KS, MO, Austria Details
Biologics American National Red Cross (The) Class III Terminated MA, ME, NH, NY, PA Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated NC Details
Biologics Biomat USA, Inc. Class II Terminated Austria Details
Biologics CSL Plasma, Inc. Class II Terminated IL, Germany, Switzerland Details
Biologics Biomat USA, Inc. Class II Terminated CA Details
Biologics Coffee Memorial Blood Center, Inc. Class II Terminated TX Details
Devices Abbott Vascular Class II Terminated Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, China, Germany, Spain, France, United Kingdom, Italy, Pakistan, Poland, Russia, Slovakia, Taiwan, and South Africa. Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution - USA including AL, CT, FL, IL, MA, MO, NJ, NY, PA, TX VA, WA, WI and Internationally to TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SOUTH AFRICA, NIGERIA, MALAYSIA, KOREA, JAPAN, INDIA, GERMANY, FRANCE, EGYPT, DENMARK, CHINA, CHILE, CANDA, BRAZIL, AUSTRIA, and GREAT BRITAIN. Details
Devices Motorola Inc Class II Ongoing Nationwide distribution Details
Devices Varian Medical Systems, Inc. Class II Ongoing US Nationwide Distribution Details
Devices MOOG Medical Devices Group Class II Ongoing Worldwide Distribution and US Nationwide in the countries of (Germany, Sweeden, Croatia, Lithuania, and Dubai). Details
Biologics Community Blood Centers of Florida, Inc. Class II Terminated Florida Details
Biologics Puget Sound Blood Center and Program Class III Terminated Washington Details
Biologics Puget Sound Blood Center and Program Class II Terminated Washington Details
Biologics Florida's Blood Centers, Inc. Class II Terminated Florida Details
Biologics Carter BloodCare Class II,Class III Terminated New Jersey; Texas Details
Biologics Puget Sound Blood Center and Program Class II Terminated California; Washington Details
Biologics LifeServe Blood Center Class II Terminated Iowa Details
Biologics Community Blood Centers of Florida, Inc. Class II Terminated Florida Details
Biologics Belle Bonfils Memorial Blood Center Class II Terminated Colorado Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Texas Details
Devices Mindray DS USA, Inc. d.b.a. Mindray North America Class II Ongoing US Nationwide Distribution including the states of: VA, TN, FL, & TX Details
Devices Extremity Medical LLC Class II Ongoing Worldwide Distribution -- Nationwide Distribution including the states of AR, AZ, CA, FL, GA, IL, IN, MD, MT, NC, NE, NH, NJ, NY, OH, PA, TN, TX, WI and WA. Details
Drugs Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals Class I Ongoing Nationwide and Puerto Rico Details
Devices Cordis Corporation Class II Ongoing US (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Hawaii. Details
Food General Mills, Inc Class II Ongoing AZ, CA, HI, ID, MT, OR, UT, WA GUAM, AMERICAN SAMOA, MEXICO, SINGAPORE, PAPUA NW GUINEA. Details
Devices Alfa Wassermann, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands Details
Devices Philips Healthcare Inc. Class II Ongoing US Nationwide Distribution including the states of AL, CA, CO, CT, IL, MD, MI, MO, NY, OH, PA Details
Devices Envoy Medical Corporation Class II Ongoing Worldwide Distribution-USA including the states of AL, AZ, CA, CT, FL, GA, IL, MA, MI, MN, NC, OK, RI, and TX, and the country of GERMANY. Details
Drugs Schering-Plough Products, LLC Class II Ongoing Nationwide and Puerto Rico Details
Devices Alere San Diego, Inc. Class III Ongoing Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea. Details
Devices Ortho-Clinical Diagnostics Class II Ongoing Worldwide Distribution, including Nationwide (USA) and the countries of AU, GM, FR, IT, SP, BR, BM, AR, CA, JA, MX, UK, CH, CL, CO, IN, EC, PE, PY, PA, PT, NZ, SG, VE and UY. Details
Food The Father's Table, LLC Class III Ongoing DOMESTIC: Arkansas, California, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Washington, and Wisconsin INTERNATIONAL: Trinidad and Tobago Details
Food J F C International Inc Class III Ongoing nationwide in the US Details
Food Chocolate Decadence Class II Ongoing Product was distributed in Arkansas California, Florida, Georgia, Indiana, Michigan, Minnesota, New Hampshire, New Jersey, New Mexico, New York, Oregon, Virginia, Washington, West Virginia, Wisconsin, Details
Food Jerusalem Manufacturing Natural Foods & Wholesalers, Inc. Class I Ongoing MI Only (Dexter and Clinton Twp) Details
Devices Roche Molecular Systems, Inc. Class II Ongoing Worldwide Distribution - Foreign (22 EU countries - Austria, Belgium, Bulgaria, Croatia, Cypress, Czech Republic, Denmark, Germany, Finland, France, Greenland, Hungary, Iceland, Italy, Luxembourg, Netherland, Norway, Sweden, Switzerland, Spain, Turkey, UK); (41 Rest of World countries - See Attachment for full country distribution + Japan, Portugal and Mexico) Details
Devices Biomet, Inc. Class II Ongoing Worldwide Distribution - USA including CA, FL, IL, AL, OH, KY, TX , and Internationally to Australia, Columbia, Mexico, Netherlands, and Chile. Details
Devices Becton Dickinson & Co. Class II Ongoing Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Canada, South Korea, Taiwan, Hong Kong, Japan, Mexico, and Singapore. Details
Food Gilster-Mary Lee Corp. Class I Ongoing Distribution made to VA, KY and TN. Details
Devices Becton Dickinson & Company Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of Canada, India, Japan, Nepal, Malaysia, Singapore, Brazil, Costa Rica, and Virgin Islands. Details
Food EonNutra, LLC Class II Ongoing Nationwide, AR, CA, CO, FL, GA, IO, MI, MO, NC, ND, NE, NJ, SC, TN, TX, UT, WI Details
Drugs Warner Chilcott Company LLC Class III Ongoing US Nationwide Details
Drugs Hillyard GMP Class II Ongoing Distribution nationwide Details
Food C H S Inc Class II Ongoing Distribution was made to MI, KY, WI, OH, Details
Devices bioMerieux, Inc. Class II Ongoing Worldwide Distribution.USA including the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WI, and WV, and the countries of China, Curacao and Japan. Details
Devices Ethicon Endo-Surgery Inc Class II Ongoing Worldwide Distribution - USA including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, & WV. and the countries Arab Emirates, Australia, Belgium, Canada, Chile, China, Colombia, Cyprus, Hong Kong, Indonesia, Israel, India, South Korea, Kuwait, Malaysia, Panama, Philippines, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovenia, Thailand, Turkey & Vietnam. Details
Food Unified Grocers Inc. Class I Ongoing WA, OR Details
Food KeHE/Tree of life Bloomington Class I Ongoing MN and PA Details
Food Jiffy Food Service, LLC Class I Ongoing Nationwide including Arizona, California, Colorado, Connecicut, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Michigan, Missouri, Montana, New England, New Jersey, New Mexico, Nevada, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virgina and Wisconsin. Details
Devices Siemens Healthcare Diagnostics, Inc. Class III Ongoing Nationwide Distribution. Details
Food Gordon Food Service, Inc. Class II Completed Florida only Details
Food Island Delights, Inc. Class I Ongoing Product was shipped to the following states: AZ, CA, FL, MA, MN, MS, NC, NY, OH, SC, TX, VA, WA & WY. Details
Food Dawn's Foods, Inc. Class II Ongoing IL, IA, WI Details
Devices Hamilton Medical Inc Class I Ongoing US Nationwide Distribution including the country of Switzerland. Details
Devices Greatbatch Medical Class II Ongoing Worldwide Distribution-USA including the states of CA, IN, KS, MA, NJ, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CANADA, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, PORTUGAL, and SWITZERLAND. Details
Devices Carestream Health, Inc. Class II Ongoing US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada. Details
Food Knotts Wholesale Foods Inc Class I Ongoing TN, KY Details
Food Belmont Confections Inc Class I Ongoing Product was shipped to the following state: Texas Details
Drugs Mylan Pharmaceuticals Inc. Class II Ongoing Nationwide. Details
Food United Natural Foods, Inc. - Greenwood Class I Ongoing Customers are retail locations in 6 states: Illinois, Indiana, Kentucky, Michigan, Missouri, and Ohio. Details
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