Enforcement Report - Week of October 17, 2012
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| Product Type | Recalling Firm | Classification | Status | Distribution Pattern | Event Details |
|---|---|---|---|---|---|
| Biologics | Community Blood Center of Greater Kansas City | Class III | Terminated | Missouri and Kansas | Details |
| Biologics | Mary Greeley Medical Center | Class II | Terminated | FL, IA, NY | Details |
| Biologics | American Red Cross Blood Services | Class II | Terminated | MO, TN, IL, TX, AR | Details |
| Biologics | BioLife Plasma Services LP | Class II | Terminated | IL | Details |
| Biologics | American National Red Cross, The | Class III | Terminated | CA | Details |
| Biologics | CSL Plasma, Inc | Class II | Terminated | IL, Switzerland & Germany | Details |
| Biologics | Mississippi Valley Reg Bld Ctr | Class II | Terminated | Missouri | Details |
| Biologics | CSL Plasma, Inc | Class II | Terminated | IL | Details |
| Biologics | CSL Plasma, Inc | Class II | Terminated | IL | Details |
| Biologics | Mississippi Valley Reg Bld Ctr | Class II | Terminated | Missouri and Illinois | Details |
| Biologics | Csl Plasma Inc | Class II | Terminated | Illinois, Switzerland, Germany | Details |
| Biologics | CSL Plasma, Inc | Class II | Terminated | IL & Switzerland | Details |
| Biologics | CSL Plasma, Inc | Class II | Terminated | IL & Switzerland | Details |
| Biologics | CSL Plasma, Inc | Class II | Terminated | IL, Switzerland & Germany | Details |
| Biologics | CSL Plasma, Inc | Class II | Terminated | Switzerland | Details |
| Biologics | CSL Plasma, Inc | Class II | Terminated | Switzerland | Details |
| Biologics | CSL Plasma, Inc | Class III | Terminated | Switzerland | Details |
| Biologics | CSL Plasma, Inc | Class II | Terminated | IL & Switzerland | Details |
| Biologics | CSL Plasma, Inc | Class II | Terminated | IL & Switzerland | Details |
| Devices | Orthohelix Surgical Designs Inc | Class II | Completed | Nationwide distribution: USA including the states of CA, CO, FL, GA, IL, MO, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA, and WI. | Details |
| Biologics | American National Red Cross (The) | Class II | Terminated | CA, MA | Details |
| Biologics | CSL Plasma, Inc. | Class II | Terminated | IL, Switzerland, Germany | Details |
| Biologics | Delta Blood Bank | Class II | Terminated | CA. | Details |
| Biologics | Delta Blood Bank | Class II | Terminated | CA. | Details |
| Biologics | Delta Blood Bank | Class II | Terminated | CA. | Details |
| Biologics | Delta Blood Bank | Class II | Terminated | CA | Details |
| Biologics | Delta Blood Bank | Class II | Terminated | CA. | Details |
| Biologics | Delta Blood Bank | Class II | Terminated | CA. | Details |
| Biologics | MedImmune, LLC | Class III | Ongoing | Product was distributed within the US to CA, FL and TX. Government account: Department of Defense, Camp Pendleton, CA. | Details |
| Food/Cosmetics | Mothers' Milk Bank at Austin | Class III | Completed | Austin,TX | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and the countries of Bangladesh, Seoul Korea, Chile, Brazil, Venesuela, Thailand, Mexico, India, Taiwan, Canada, Dominican Republic, Guatemala, Ecuador, Germany, Republic of Georgia, Hong Kong, Japan, United Arab Emirates (UAE), Japan, Belgium, Phillipines, Singapore, and South Africa. | Details |
| Biologics | LifeSouth Community Blood Centers Inc - Birmingham Region | Class II | Terminated | Alabama | Details |
| Biologics | Octapharma Plasma, Inc. | Class II | Terminated | Austria | Details |
| Biologics | Central California Blood Center | Class II | Terminated | California; Florida | Details |
| Biologics | Florida's Blood Centers, Inc. | Class II | Terminated | Florida | Details |
| Biologics | The American National Red Cross - Southern Region | Class II | Terminated | Georgia | Details |
| Biologics | Interstate Blood Bank Inc. of Wisconsin | Class II | Terminated | Germany, Israel | Details |
| Biologics | Community Blood Center | Class III | Terminated | Ohio | Details |
| Biologics | Sunquest Information Systems, Inc. | Class II | Terminated | Nationwide | Details |
| Drugs | Actavis Mid Atlantic LLC | Class III | Ongoing | Nationwide & Puerto Rico | Details |
| Devices | Siemens Healthcare Diagnostics, Inc. | Class II | Ongoing | United States Nationwide Distribution in the states of: CA, FL, KS, MA, MN, MS, NM, NY, NC, OR, PA, TN, TX, UT, VA, and WA. | Details |
| Biologics | Greer Laboratories Inc | Class II | Ongoing | CA, IL, IA, NM, TN | Details |
| Devices | Immunodiagnostics Systems Ltd | Class II | Ongoing | Nationwide Distribution including NY, CA, ME and CT. | Details |
| Biologics | Associates of Cape Cod, Inc. | Class III | Ongoing | CA, IA, FL, MN, NC, NY, SC, TX Foreign: Canada, Columbia, Brazil, Ecuador, Guatemala, Hong Kong, Indonesia, Korea, Russian Federation, UK, Taiwan | Details |
| Food/Cosmetics | Pacific Northwest Tofu, LLC | Class II | Completed | Product distributed in Oregon | Details |
| Food/Cosmetics | Cinnabar Specialty Foods Inc | Class II | Ongoing | Nationwide to following states: MT, CA, AZ, PA, NC, TX, VA, IL, MI, CO, UT, GA, WA, WY, AK, FL, MO, ID. | Details |
| Food/Cosmetics | Mothers' Milk Bank at Austin | Class II | Completed | TX | Details |
| Devices | Biomerieux Inc | Class II | Ongoing | Worldwide Distribution-USA (nationwide)-including DC and the states of CA, CO, CT, FL, GA, IL, IN, KY, LA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TX, and WI, and the country of Canada. | Details |
| Biologics | Siemens Healthcare Diagnostics Inc. | Class II | Ongoing | Nationwide; Also to Thailand, South Africa, Chile, Peru, Belgium, Bolivia, Ecuador, Uruguay. Mexico, China, Spain, Italy, Australia, France and Brazil. | Details |
| Devices | Siemens Medical Solutions USA, Inc | Class II | Ongoing | Nationwide Distribution including the states of MO, FL, MA, NY, WI, GA, CA and WA. | Details |
| Devices | Baxter Healthcare Corp. | Class I | Ongoing | Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom. | Details |
| Devices | Remington Medical Inc. | Class II | Ongoing | Nationwide distribution: USA including states of: AL, AZ, CA, FL, IN, MA, NC, NY, OH, PA and TX. | Details |
| Biologics | Immucor Inc | Class II | Ongoing | Nationwide, Bahrain, Canada, China, Columbia, Germany, South Africa, Ireland, Japan, New Zealand, Norway, Peru, and South Korea | Details |
| Food/Cosmetics | Manna Organics Inc | Class I | Ongoing | NY, NJ, PA, MA, VA, MD, CT, GA, IL, and TX | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide distribution: USA including AK, AL, AR, AZ, CA, CO, CT, DC | Details |
| Devices | Winco Mfg., LLC | Class II | Ongoing | Worldwide Distribution - USA including Arkansas, California, Maryland, Mississippi, New York, Pennsylvania and the country of Saudi Arabia | Details |
| Food/Cosmetics | Spokane Produce, Inc. | Class I | Ongoing | Retail accounts in ID, MT and WA | Details |
| Food/Cosmetics | Eco Health, Inc. | Class I | Ongoing | Nationwide in the US | Details |
| Devices | Kardium | Class II | Ongoing | Nationwide Distribution-including the states of FL, GA, IL, and NH. | Details |
| Devices | Beckman Coulter Inc. | Class II | Terminated | Worldwide Distribution - US Natiowide including the state of: OH, CT, CA and the state of Argentina, Austria, Belgium, Brazil, Canada, China, Columbia, Czech Republic, France, Germany, Greece, Hungary, Italy, Kuwait, Netherlands, Poland, Portugal, Slovakia, Spain, Switzerland, Turkey, and United Kingdom. | Details |
| Food/Cosmetics | Forever Cheese Inc | Class I | Ongoing | Nationwide | Details |
| Devices | Advanced Neuromodulation Systems Inc. | Class II | Ongoing | US Nationwide Distribution | Details |
| Devices | Medtronic Sofamor Danek USA Inc | Class II | Ongoing | Worldwide Distribution-USA (nationwide) and the countries of India, Netherlands, Hong Kong, S. L Korea, Singapore, Canada, Australia, Japan, and Mexico. | Details |
| Devices | Beckman Coulter Inc. | Class II | Ongoing | Worldwide Distribution-USA (nationwide) and the counties of Australia, Belgium, Canada, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of Kuwait, Macao, Malaysia, Mexico, Netherlands, Norway, Oman, Panama, Philippines, Puerto Rico, Qatar, Romania, Russian, Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom. | Details |
| Devices | Beckman Coulter Inc. | Class II | Terminated | Worldwide Distribution - USA (nationwide) and the following countries: Albania Australia Austria Bahrain Bangladesh Barbados Belarus Belgium Bosnia and Herzegovina Bulgaria Burundi Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador El Salvador Finland France French Guiana French Polynesia Germany Greece Guadeloupe Hong Kong India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea, Republic of Kuwait Libyan Arab Jamahiriya Lithuania Macao Malaysia Mexico Monaco Morocco Namibia Netherlands New Zealand Nigeria Norway Oman Pakistan Panama Poland Puerto Rico Qatar Reunion Romania Russian Federation Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sudan Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom Uruguay | Details |
| Food/Cosmetics | Newark Nut Stores, Inc. | Class I | Ongoing | Nationwide | Details |
| Food/Cosmetics | Springside Cheese Corp | Class II | Ongoing | WI, CO | Details |
| Devices | Beckman Coulter Inc. | Class II | Ongoing | Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Australia, Bangladesh, Belgium, Botswana, Brazil, Canada, China, Colombia, Czech Republic, Croatia, Ecuador, Ethiopia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zimbabwe. | Details |
| Devices | Accutron Inc | Class I | Ongoing | US Nationwide Distribution | Details |
| Devices | Alere San Diego, Inc. | Class II | Terminated | Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Colombia, Czech Republic, Finlind, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, India, Indonesia, Italy, Lebanon, Mexico, Netherlands, Norway, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, and Uruguay. | Details |
| Food/Cosmetics | Chang Jiang Seafood Ca Inc | Class III | Ongoing | AZ, CA, UT | Details |
| Food/Cosmetics | World Finer Foods, Inc. | Class II | Ongoing | Nationwide | Details |
| Food/Cosmetics | GM Distributing Co, Inc | Class I | Ongoing | AZ, GA, IL, MN, NY, and TX | Details |
| Food/Cosmetics | Pepsi Bottling Group Nashville | Class II | Completed | GA, TN, KY, and IN | Details |
| Food/Cosmetics | United Salad Company | Class I | Ongoing | Distributed to wholesale and retail customers in Alaska, Idaho, Montana, Oregon and Washington | Details |
| Food/Cosmetics | Cut Fruit Express, Inc. | Class I | Ongoing | MI, MN, WI | Details |
| Devices | Optovue Inc. | Class II | Ongoing | Worldwide distribution -- USA (nationwide) and Internationally. | Details |
| Devices | 3M Company - Health Care Business | Class II | Ongoing | Worldwide Distribution--USA (nationwide) including the states of AL, CO, CT, GA, IN, KY, MA, MI, MN, MO, MS, NJ, OH, PA, SC, TN, VA, WA and WI., and the countries of Argentina, Barbados, Chile, China, Colombia, Costa Rica, Ecuador, Germany, India, Indonesia, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Pakistan, Paraguay, Peru, Philippines, Poland, Republic of Guinea, Russia, South Africa, Taiwan, Thailand, Trinidad, UAE, Venezuela, Vietnam and Zimbabwe. | Details |
| Food/Cosmetics | Kroger Co | Class I | Ongoing | Product was shipped to the following states: AL, GA, IL, IN, KS, KY, MI, MO, NC, NE, OH, SC, TN, VA & WV. | Details |
| Food/Cosmetics | 3fish Inc. | Class I | Ongoing | NC and SC | Details |
| Food/Cosmetics | Fresh Express Incorporated | Class I | Ongoing | Initial distribution to: IL, MI, MN, ND, NY, NJ, SD, WI, IA, IN, OH and PA. Waiting for distribution information from firm. | Details |
| Food/Cosmetics | G.O. Fresh | Class I | Ongoing | Minnesota, Iowa, North Dakota and Wisconsin | Details |
| Drugs | Paddock Laboratories, LLC | Class II | Ongoing | Nationwide | Details |
| Devices | ICU Medical, Inc. | Class II | Ongoing | Nationwide distribution: Virginia only. | Details |
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