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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Drugs Apotex Corp. Class II Terminated Nationwide. Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated NY; Austria Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated FL Details
Biologics Community Blood Center Of Gtr KC Class III Terminated Missouri. Details
Biologics American Red Cross Blood Services Class II Terminated KS, KY Details
Biologics ZLB Bioplasma, Inc. Class II Terminated CA, NC 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, KS Details
Biologics Community Blood Center Of Gtr KC Class II,Class III Terminated KS, Switzerland. Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated FL, Austria Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated NJ; Austria Details
Biologics Mississippi Valley Regional Blood Center Class II Terminated California Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated NE, Austria Details
Biologics Community Blood Center of Greater Kansas City Class II Terminated MO Details
Devices SRI Surgical Class II Completed Nationwide Distribution-including the states of CA, FL, GA, KY, MD, MI, NC, NJ, OK, PA, SC, TN, TX, and UT. Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated FL, NJ, NY Details
Biologics Mississippi Valley Reg Bld Ctr Class III Terminated Missouri, California Details
Biologics Csl Plasma Inc Class II Terminated Illinois, California, Switzerland, Germany Details
Biologics Csl Plasma Inc Class II Terminated Illinois, Switzerland, Germany Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated NY Details
Devices Alphatec Spine, Inc. Class II Completed Nationwide Distribution. Details
Devices Toshiba American Medical Systems Inc Class II Completed Nationwide distribution: USA including states of: AL, AR, CA, CO, FL, GA, KY, MA, MD, MT, ND, NJ, NV, NY, OH, PA and Puerto Rico. Details
Biologics CSL Plasma Inc Class II Terminated Illinois; Switzerland; Germany Details
Biologics Csl Plasma Inc Class II Terminated IL, California Details
Biologics Octapharma Plasma, Inc. Class III Terminated CA, Austria Details
Devices Sendx Medical Inc Class II Completed Worldwide Distribution - US Nationwide including the state of OH. Details
Devices Advanced Neuromodulation Systems Inc. Class II Ongoing Nationwide within the US, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Isreal, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom. Details
Devices Unimed Surgical Products, Inc. Class II Terminated US Nationwide Distribution - including the state of IL. Details
Food Ciolino Wholesale Produce, Inc. Class I Ongoing MI and OH distribution only. Retail only. Details
Food Pure Hothouse Foods Inc. Class I Ongoing Meijer stores in Michigan, Ohio, Indiana, Illinois, and Kentucky Details
Devices Atlas Spine, Inc. Class II Ongoing USA Distribution to the state of Florida only. Details
Devices Phadia US Inc Class III Ongoing USA Nationwide. Details
Devices Biomet 3i, LLC Class II Ongoing Worldwide Distribution-Distributed in the USA and the countries to Spain, France, Germany, Switzerland, and Australia. Details
Drugs Bracco Diagnostic Inc Class III Ongoing Nationwide Details
Food Cass Clay Creamery AMPI Fargo Division Class I,Class II,Class III Ongoing ND, AZ, MN, SD, KS Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing Nationwide Distribution-CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI. Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing Nationwide Distribution -- CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI. Details
Food Burch Farms Class I Ongoing NY; Expanded on 8/2 to include FL, GA, IL, MD, NC, NJ, PA, SC and VA. Details
Food Rita's Fine Food, Inc. Dba Da Vinci's Class II Ongoing CA Details
Devices Nellcor Puritan Bennett Inc. (dba Covidien LP) Class II Ongoing Worldwide distribution: USA (nationwide) and countries including: Australia, Brazil, Canada, Columbia, Deutchland, France, Japan, Mexico, Panama, Puerto Rico, Singapore, and Uruguay. Details
Devices Sunquest Information Systems, Inc. Class II Terminated Worldwide Distribution -- USA (nationwide) and the country of Canada. Details
Devices Siemens Healthcare Diagnostics, Inc. Class III Ongoing Nationwide Distribution - USA including AK, AL, AR, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, WA, WI, WV, and WY. Details
Devices Sunquest Information Systems, Inc. Class II Terminated Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Denmark, Ireland, the United Arab Emirates and the United Kingdom. Details
Devices GE OEC Medical Systems, Inc Class I Completed Worldwide Distribution - USA (nationwide) and the countries of India, Japan, Canada, Switzerland, Italy, United Kingdom, Germany, Austria, Hong Kong, France, and Denmark. Details
Food Busch's, Inc. - Central Production Facility Class I Ongoing Michigan Distribution only. Details
Food Four Brothers Packaging Corporation Class II Ongoing MI distribution only...others unknown Details
Drugs Bracco Diagnostic Inc Class II Ongoing Nationwide Details
Drugs Capco Custom Packaging Inc Class II Ongoing Nationwide and Canada Details
Food Fresh Ideas Inc. Class I Ongoing MA, ME, RI, NH, CT, VTM, NY AND Nj Details
Food Amy'S Kitchen Class I Ongoing Products were released for distribution in US (PA, TN, IL, CA). Details
Drugs Natural Essentials Inc Class III Ongoing Nationwide Details
Food Nha Trang Seafoods, Inc Class III Ongoing One consignee (distributor) in CA. Details
Food Reichel Foods, Inc Class I Ongoing nationwide Details
Devices I-Flow Corporation Class I Ongoing Worldwide Distribution -- USA, Canada, Australia, the EU (Germany), United Arab Emirates, and Cyprus. Details
Devices Cisco Systems Inc Class II Terminated Nationwide Distribution including the state of TN. Details
Devices Steris Corporation Class II Ongoing Nationwide distribution: USA including states of: AR, AK, CA, CO, DE, FL, IL, MA, MD, NC, NE, NH, NY, OH, PA, SD, TN, TX, WI, and WV. Details
Drugs Island Kinetics dba Covalence Class II Ongoing Atlanta, Georgia Details
Devices Bard Access Systems Class III Ongoing National US distribution only: MO, KS, AZ, OK, OR, AL, MA, TX, FL, MI, OH, LA, NJ, NC, WA, AR. Details
Food Shin Shin Foods, Inc. Class II Terminated Product was distributed in Oregon. Details
Food Lucky Country, Inc. Class II Ongoing AZ, CA, UT Details
Drugs GlaxoSmithKline Inc Class II Ongoing Nationwide Details
Devices Encore Medical, Lp Class II Ongoing Worldwide Distribution including Venezuela. Details
Drugs Galderma Laboratories, L.P. Class III Ongoing Nationwide and Puerto Rico. Details
Devices Canon Inc. Class II Ongoing Nationwide Distribution (USA) Details
Devices Toshiba American Medical Systems Inc Class II Completed USA ( Nationwide Distribution ) Details
Devices Toshiba American Medical Systems Inc Class II Completed Nationwide Distribution Details
Devices Metrex Research, LLC. Class II Terminated Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, and YE. Details
Devices Philips Healthcare Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, DENMARK, EL SALVADOR, FRANCE, GERMANY, ICELAND, INDIA, IRELAND ISRAEL, ITALY, JORDAN, KENYA, LEBANON, MALAYSIA,NAMIBIA NETHERLANDS, NORWAY, POLAND, PORTUGAL, RWANDA SAUDI ARABIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, UNITED ARAB EMIRATES, and UNITED KINGDOM. Details
Food Honey Heaven Wholesale, Inc. Class I Ongoing Product was distributed to retail stores in California, Oregon and Washington Details
Devices Mindray DS USA, Inc. d.b.a. Mindray North America Class II Ongoing Worldwide Distribution - US Nationwide including the states of: NY, SD, NE, IL, MO, CA, OH, OK, WA, IN, WY, CO, TX, FL, NC, AL and Puerto Rico. and the countries of: Australia, Canada, Columbia, New Zealand, Pakistan, Russia, Saudi Arabia, United Kingdom and Venezuela. Details
Devices Baxter Healthcare Corp. Class III Terminated 45,865 units Details
Food Real Mex Foods Class I Ongoing Distribution to food service such as restaurants. Details
Drugs VistaPharm, Inc. Class III Terminated Nationwide Details
Food Tanimura & Antle Class I Ongoing AL, AR, AZ, CA, GA, KS, KY, MD, NC, NM, NV, NJ, PA, SC, TN, TX, VA and WA and Canada. Details
Food SUNFRESH NATURAL LLC. Class II Ongoing New Jersey and New York Details
Devices Advanced Sterilization Products Class II Ongoing Worldwide Distribution, including Nationwide (USA). Details
Drugs Apotex Corp. Class III Ongoing Nationwide and Puerto Rico Details
Food Dole Fresh Vegetables Inc Class I Ongoing Distributors in FL, NC, PA, SC, VA, MD and AL Details
Food Naturally Fresh Inc. Class I Ongoing AL, FL, GA, LA, MI, SC and TX. Details
Drugs Hospira Inc. Class II Ongoing Nationwide Details
Food Interstate Seafood Inc Class II Terminated Nationwide in the US: CA, CO, IL, TX, UT Details
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