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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics American National Red Cross (The) Class II Terminated New York Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida Details
Biologics Community Blood Center of the Ozarks Class II,Class III Terminated MO; CO; FL; Austria Details
Biologics Northwest Florida Blood Center, Inc. Class II Terminated Florida Details
Biologics Northwest Florida Blood Center, Inc. Class II Terminated Florida Details
Biologics BioLife Plasma Services L.P. Class II Terminated North Carolina Details
Biologics Northwest Florida Blood Center, Inc. Class III Terminated Florida Details
Biologics Northwest Florida Blood Center, Inc. Class III Terminated Florida Details
Biologics Atlanta Blood Services Class III Terminated GA Details
Biologics Community Blood Center of the Ozarks Class II Terminated MO; AL; NJ; TX; OH; AR; FL; TN; MD Details
Biologics New York Blood Center, Inc. Class II Terminated New York, California Details
Biologics Hoxworth Blood Center University of Cincinnati Medical Center Class II Terminated Ohio. Details
Biologics American Red Cross Blood Services Class II Terminated CO; NE; PA; IA; MA; TX; NY; IL; ME; MI Details
Biologics Lane Memorial Blood Bank Class II Terminated Switzerland, ID, Alaska, HI, CA, FL, TN, OR, NY Details
Biologics American National Red Cross (The) Class II Terminated Ohio Details
Biologics Northwest Florida Blood Center, Inc. Class II Terminated Florida, Alabama. Details
Biologics Northwest Florida Blood Center, Inc. Class III Terminated Florida. Details
Biologics Florida Georgia Blood Alliance, Inc. Class II Terminated Florida Details
Biologics American National Red Cross (The) Class III Terminated New York Details
Biologics American National Red Cross (The) Class II Terminated NY Details
Devices Fisher & Paykel Healthcare, Ltd. Class II Ongoing Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan. Details
Biologics American National Red Cross (The) Class II Terminated New York Details
Biologics American National Red Cross (The) Class II Terminated New York Details
Biologics Tacoma Pierce County Blood Bank Class III Terminated Washington and Utah Details
Biologics American Red Cross Blood Services Class II Terminated NE; CO; PA; NJ; AL; OK Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated North Carolina. Details
Biologics Plasma Biological Services Inc Class II Terminated North Carolina Details
Biologics American Red Cross Blood Services Class II Terminated Missouri; Texas; Kentucky Details
Biologics Plasma Biological Services Inc Class II Terminated North Carolina Details
Food Hong Lee Trading Inc Class I Terminated Nationwide Details
Devices Orthovita, Inc., dBA Stryker Orthobiologics. Class II Ongoing USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI. Details
Food The Sourdough: A European Bakery Inc. Class I Completed AR, LA, OK, and TX Details
Food Pecan Deluxe Candy Company Class I Ongoing CA, IA, MI, MO, NC, NV, NY, OH, PA, TX, UT, WI and Canada Details
Food Nature's Candy, Inc. Class I Ongoing CA and CO Details
Devices Beckman Coulter Inc. Class II Ongoing Worldwide Distribution - USA Nationwide and the countries of Canada, Australia, Belgium, Czech Republic, France, French Polynesia, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Jordon, Kuwait, Lebanon, Malawi, Morocco, Namibia, Netherlands, oman, Panama, Paraguay, Qatar, Reunion, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom Details
Devices Spinal Solutions, LLC Class II Ongoing USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI. Details
Devices Orthopedic Alliance LLC Class II Ongoing Nationwide Distribution including the states of CA, MD, TX, NV, and WI. Details
Drugs Teva Pharmaceuticals USA, Inc. Class III Ongoing Nationwide Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated Nebraska Details
Biologics Florida's Blood Centers, Inc. Class II Terminated Florida Details
Biologics Blood Bank Of San Bernardino And Riverside Counties Class II Terminated California; Georgia Details
Biologics Community Blood Center of Carolinas Class II Terminated North Carolina Details
Devices The Anspach Effort, Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) including DC and the states of OH, TX, IL, CA, GA, KY, FL, WI, NC, VA, WI, MN, MD, KS, OK, PA, OR ,HI, AZ, WA, TN, AR, IA, MI, CO, LA, NJ, IN, WV, MO, AL, NY, VT, and SC and the countries of France, Canada, Great Britain, Mexico, Australia, Sweden and Netherlands. Details
Drugs Physicians Total Care, Inc. Class III Completed MO Details
Food 7-Eleven Stores of Oklahoma Class I Ongoing Oklahoma Details
Drugs Mylan Pharmaceuticals Inc. Class II Ongoing Nationwide Details
Drugs Nora Apothecary and Alternative Therapies, Inc. Class II Ongoing Nationwide Details
Devices Intel-GE Care Innovations LLC Class II Ongoing US and Great Britain Details
Devices Zimmer, Inc. Class II Ongoing Nationwide Distribution. Details
Devices Alere San Diego, Inc. Class II Ongoing United States Nationwide Distribution Details
Devices Elekta, Inc. Class II Ongoing USA Nationwide including the states of CA, FL, IL, MD, MA, NJ, NY, NC, ND, OH, OR, PA, TN, TX, VA, WA, DC and Puerto Rico Details
Devices Polymer Technology Systems, Inc. Class II Ongoing Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: UK, CHL, ENG, BEL, ITA, TKY, BEL, LIT, LTV, EGY, SPG, HOK, SWE, MEX, UAE, COR, ISR, MAL, AUS, POR, POL, SLN and STQ. Details
Devices Nephron Pharmaceuticals Corp. Class I Ongoing Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AZ, CA, CO, CT, FL, IL, IN, IO, GA, KS, KY, LA, MD, MN, MS, MO, NK, NV, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN , TX, VT, VA, WA, and WV, and the countries of Guatemala, Poland, Panama, and United Kingdom. Details
Drugs Aurobindo Pharma USA Inc Class III Ongoing Nationwide Details
Devices Intuitive Surgical, Inc. Class II Terminated USA Nationwide distribution Details
Devices Intuitive Surgical, Inc. Class II Terminated Worldwide distribution - USA Nationwide and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom. Details
Food Meijer Distribution, Inc Class III Ongoing Meijer stores (201) located in Illinois, Indiana, Kentucky, Michigan, and Ohio may have received product from Meijer distribution centers. Details
Devices Canon Inc. Class II Ongoing Worldwide Distribution - USA Nationwide and countries of: Australia, Japan, Korea, Singapore and United Kingdom. Details
Devices Intuitive Surgical, Inc. Class II Terminated Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela. Details
Devices Heart Sync, Inc Class II Ongoing Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea. Details
Devices Becton Dickinson & Co. Class II Ongoing Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan. Details
Devices Intuitive Surgical, Inc. Class II Terminated US Distribution Only Details
Food National Food & Beverage, Inc Class III Ongoing FL, GA, and SC Details
Devices Beckman Coulter Inc. Class II Ongoing Worldwide Distribution-USA Nationwide and countries of: AU, CA, DE, ES, GB, IT, PT, and JP. Details
Devices Angiodynamics, Inc. Class II Ongoing USA Nationwide Distribution including the states of: IL, GA, CA, NY OH, AZ, TX, NE, FL, PA, NC, WI, AL, IN, CO, MO, MT, NE, MA, VA, AK, IN, MI, NJ, MD, TN, CT, WA, MN Details
Devices TZ Medical Inc. Class II Ongoing Worldwide distribution - USA (nationwide) and Chile. Details
Food Talenti Gelato Class II Ongoing IN Details
Devices RAYSEARCH LABORATORIES AB Class II Ongoing Worldwide Distribution - USA including Connecticut, Florida, Massachusetts, Missouri, New York, Ohio, and foreign distribution to(Canada, Italy, Australia, Germany, Netherlands, and Switzerland. Details
Devices Merit Medical Systems, Inc. Class II Ongoing USA Nationwide Distribution. Details
Devices Alphatec Spine, Inc. Class II Ongoing Nationwide Distribution. Details
Devices Alpine Biomed Aps Class II Ongoing Worldwide Distribution - US Nationwide and the countries of: Germany, France, Bulgaria, India, Colombia, Tunisia, Saudi Arabia, Finland, Denmark, Brasil, Italy, Estonia, South Korea, Russia, Greece, Thailand, Israel, Poland, Turkey, Slovakia, Portugal, Switzerland, Hungary, Great Britain, Netherlands, China, Indonesia, Australia, Sweden, Spain, Iran, Singapore, Norway, Austria and Czech Republic. Details
Devices Intuitive Surgical, Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of AL, CA, CO, FL, IL, KY, MI, MS, NJ, NY, PA, TX, UT, VA, WA, and WI, and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Norway, Qatar, Romania, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Saudi Arabia, Singapore, and Venezuela. Details
Food Tropical Valley Foods, Inc. Class I Ongoing Michigan, Oregon, Colorado, and New Jersey Details
Food Arthur Schuman Midwest LLC Class I Ongoing Nationwide (MA and VA) Details
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