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/Cosmetics | Ciolino Wholesale Produce, Inc. | Class I | Ongoing | MI and OH distribution only. Retail only. | Details |
| Food/Cosmetics | 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/Cosmetics | 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/Cosmetics | Burch Farms | Class I | Ongoing | NY; Expanded on 8/2 to include FL, GA, IL, MD, NC, NJ, PA, SC and VA. | Details |
| Food/Cosmetics | 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/Cosmetics | Busch's, Inc. - Central Production Facility | Class I | Ongoing | Michigan Distribution only. | Details |
| Food/Cosmetics | 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/Cosmetics | Fresh Ideas Inc. | Class I | Ongoing | MA, ME, RI, NH, CT, VTM, NY AND Nj | Details |
| Food/Cosmetics | 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/Cosmetics | Nha Trang Seafoods, Inc | Class III | Ongoing | One consignee (distributor) in CA. | Details |
| Food/Cosmetics | 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/Cosmetics | Shin Shin Foods, Inc. | Class II | Terminated | Product was distributed in Oregon. | Details |
| Food/Cosmetics | 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/Cosmetics | 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/Cosmetics | Real Mex Foods | Class I | Ongoing | Distribution to food service such as restaurants. | Details |
| Drugs | VistaPharm, Inc. | Class III | Terminated | Nationwide | Details |
| Food/Cosmetics | 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/Cosmetics | 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/Cosmetics | Dole Fresh Vegetables Inc | Class I | Ongoing | Distributors in FL, NC, PA, SC, VA, MD and AL | Details |
| Food/Cosmetics | Naturally Fresh Inc. | Class I | Ongoing | AL, FL, GA, LA, MI, SC and TX. | Details |
| Drugs | Hospira Inc. | Class II | Ongoing | Nationwide | Details |
| Food/Cosmetics | Interstate Seafood Inc | Class II | Terminated | Nationwide in the US: CA, CO, IL, TX, UT | Details |
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