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/Cosmetics | 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/Cosmetics | 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/Cosmetics | J F C International Inc | Class III | Ongoing | nationwide in the US | Details |
| Food/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | Unified Grocers Inc. | Class I | Ongoing | WA, OR | Details |
| Food/Cosmetics | KeHE/Tree of life Bloomington | Class I | Ongoing | MN and PA | Details |
| Food/Cosmetics | 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/Cosmetics | Gordon Food Service, Inc. | Class II | Completed | Florida only | Details |
| Food/Cosmetics | 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/Cosmetics | 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,Class III | Ongoing | US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada. | Details |
| Food/Cosmetics | Knotts Wholesale Foods Inc | Class I | Ongoing | TN, KY | Details |
| Food/Cosmetics | 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/Cosmetics | 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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