Enforcement Report - Week of July 25, 2012
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| Product Type | Recalling Firm | Classification | Status | Distribution Pattern | Event Details |
|---|---|---|---|---|---|
| Biologics | The American National Red Cross - Southern Region | Class II,Class III | Terminated | AL, CA, CT, FL, GA, MS, NC, PA, SC & TX | Details |
| Biologics | American National Red Cross (The) | Class II,Class III | Terminated | OH , CA. | Details |
| Biologics | American National Red Cross (The) | Class II | Terminated | Ohio. | Details |
| Biologics | American National Red Cross (The) | Class II | Terminated | Ohio. | Details |
| Biologics | American National Red Cross (The) | Class II | Terminated | The ARC Blood Center in Cleveland, OH distributed products to three hospitals in Ohio. | Details |
| Biologics | American National Red Cross (The) | Class II,Class III | Terminated | Ohio. | Details |
| Biologics | American National Red Cross (The) | Class II,Class III | Terminated | CA | Details |
| Biologics | American National Red Cross (The) | Class III | Terminated | CA | Details |
| Biologics | The American National Red Cross - Southern Region | Class III | Terminated | GA, AR | Details |
| Biologics | American National Red Cross (The) | Class II | Terminated | CA. | Details |
| Biologics | Biomat USA, Inc. | Class III | Terminated | Blood products were released for distribution in a foreign country. | Details |
| Biologics | Sacramento Medical Foundation | Class III | Terminated | CA. | Details |
| Biologics | Sacramento Medical Foundation | Class II | Terminated | CA. | Details |
| Biologics | Sacramento Medical Foundation | Class III | Terminated | CA. | Details |
| Biologics | Biomat USA, Inc. | Class III | Terminated | MA. | Details |
| Biologics | Biomat USA, Inc. | Class II | Terminated | Spain | Details |
| Biologics | American National Red Cross (The) | Class III | Terminated | CA | Details |
| Biologics | BioLife Plasma Services L.P. | Class II | Terminated | CA | Details |
| Biologics | American National Red Cross (The) | Class II | Terminated | CA | Details |
| Biologics | American National Red Cross (The) | Class III | Terminated | CA | Details |
| Biologics | BioLife Plasma Services L.P. | Class II | Terminated | CA | Details |
| Biologics | BioLife Plasma Services L.P. | Class III | Terminated | CA | Details |
| Biologics | American National Red Cross (The) | Class II,Class III | Terminated | CA | Details |
| Biologics | New York Blood Center,inc-cellular Therapy Laboratory | Class III | Terminated | NY | Details |
| Biologics | Blood Centers of the Pacific | Class II | Terminated | CA | Details |
| Biologics | Community Blood Center of Greater Kansas City | Class II | Terminated | MO | Details |
| Biologics | ZLB Bioplasma Services | Class III | Terminated | NC | Details |
| Biologics | Coral Blood Services, Inc. | Class II | Terminated | ME | Details |
| Biologics | ZLB Bioplasma Services | Class III | Terminated | NC, Switzerland | Details |
| Biologics | Blood Centers of the Pacific | Class II | Terminated | CA | Details |
| Biologics | Blood Centers of the Pacific | Class II | Terminated | CA and Austria | Details |
| Biologics | ZLB Bioplasma Services | Class II | Terminated | NC, Germany | Details |
| Biologics | ZLB Bioplasma Services | Class II | Terminated | NC | Details |
| Biologics | ZLB Bioplasma Services | Class II | Terminated | NC | Details |
| Biologics | ZLB Bioplasma Services | Class II | Terminated | Switzerland, NC | Details |
| Biologics | ZLB Bioplasma Services | Class II | Terminated | NC | Details |
| Biologics | Hoxworth Blood Center University of Cincinnati Medical Center | Class II | Terminated | OH. | Details |
| Biologics | Hoxworth Blood Center University of Cincinnati Medical Center | Class II | Terminated | OH, KY | Details |
| Biologics | BioLife Plasma Services L.P. | Class II | Terminated | CA | Details |
| Biologics | Blood Centers of the Pacific | Class II | Terminated | CA, Austria | Details |
| Biologics | American National Red Cross (The) | Class II | Terminated | OH | Details |
| Biologics | American National Red Cross (The) | Class II | Terminated | KY, IN, CA. | Details |
| Drugs | Pack Pharmaceuticals | Class III | Terminated | Nationwide | Details |
| Food/Cosmetics | Nutri-Health Supplements Llc. | Class I | Ongoing | Distributed to retail natiowide to US states. | Details |
| Biologics | Florida's Blood Centers, Inc. | Class II | Terminated | FL, CA, NY, NC, SC | Details |
| Biologics | Talecris Plasma Resources, Inc. | Class II | Terminated | NC | Details |
| Biologics | Plasma Biological Services Inc | Class III | Terminated | Austria, Ireland, CA, PA | Details |
| Biologics | Talecris Plasma Resources, Inc. | Class II | Terminated | CA. Name and address of consignee involved: Talecris Biotherapeutics, Inc. (TBI), 8368 US 70 Business Highway West, Clayton, NC 27520 | Details |
| Biologics | Blood Systems, Inc. | Class III | Terminated | NM | Details |
| Biologics | Allograft Innovations, LLC | Class II | Ongoing | Affected products were distributed to Israel, South Korea, United Kingdom , Turkey and domestically to TX, FL, MI, IN, NJ, IL, MO AZ, OK, OK and WI. | Details |
| Veterinary | Cargill Inc Animal Nutrition Division | Class I | Ongoing | LA, MS, TN | Details |
| Devices | Epocal Inc | Class II | Ongoing | US nationwide Distribution in the state of CA. | Details |
| Devices | Etac Supply Center Ab | Class II | Ongoing | Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, China, Colombia, Germany, Denmark, Estonia, Spain, Finland, France, Great Brittain, Greenland, Greece, Hungaria, Ireland, Israel, Iceland, Italy, Japan, South Korea, Kuwait, Lithuania, Luxembourg, Latvia, Malaysia, Netherlands, Norway, Poland, Portugal, Rumania, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, and Thailand. | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, BANGLADESH, BELGIUM, Bolivia, BRAZIL, BRISBANE, CANADA, CHILE, China, COLOMBIA, COLOMBIA, Costa Rica, DENMARK, Dominican Republic, Ecuador, Egypt, FRANCE, GERMANY, Guatemala, HOLLAND, Honduras, Hong Kong, India, INDIA, Indonesia, Israel, ITALY, Jordan, KOREA, Kuwait, Lebanon, LEICESTERSHIRE, Malaysia, Mexico, NETHERLANDS, New Zealand, Nicaragua, NORWAY, Pakistan, Panama, PERU, Philippines, Russia, Saudi Arabia, SINGAPORE , SOUTH AFRICA, South Korea, SPAIN, Sri Lanka, SWEDEN, SWITZERLAND, Taiwan, THAILAND, Turkey, UNITED ARAB EMIRATES (UAE), Uruguay, Venezuela, Vietnam, WEST GERMANY and Yemen. | Details |
| Drugs | Hospira Inc. | Class I | Ongoing | Nationwide | Details |
| Drugs | Meda Pharmaceuticals Inc. | Class II | Ongoing | Nationwide | Details |
| Devices | Sigma | Class III | Ongoing | Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada. | Details |
| Drugs | Luitpold Pharmaceuticals, Inc. | Class II | Ongoing | Nationwide | Details |
| Devices | Stryker Spine | Class II | Ongoing | Nationwide. | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV. and the countries of ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam. | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide Distribution-USA (nationwide) including the states of , AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam. | Details |
| Devices | Becton Dickinson & Co. | Class II | Completed | Nationwide Distribution. | Details |
| Food/Cosmetics | Old Fashioned Foods, Inc. | Class II | Ongoing | CA, MI, OH, WI | Details |
| Veterinary | Natural Balance Pet Food Inc. | Class I | Ongoing | Nationwide: PA, NC, AL, FL, OH, WI, MN, IL, MI, NJ, GA, TX, MA, CA Worldwide: Taiwan, Israel, and Canada. | Details |
| Veterinary | Pegasus Laboratories, Inc. | Class II | Ongoing | Product was distributed to FL, OR, OH, PA, CA, TX, MO, NY, MN, IA, NE, NJ. | Details |
| Drugs | Bayer Healthcare, LLC | Class III | Ongoing | Product was distributed to 93 retail accounts/customers. | Details |
| Drugs | JHP Pharmaceuticals, LLC | Class III | Ongoing | Nationwide and Puerto Rico | Details |
| Devices | EKOS Corporation | Class II | Ongoing | Worldwide Distribution - USA including OH, KY, and TN and the countries of Switzerland, Germany, Austria, Czech Republic, Slovakia Republic, Poland, Netherlands, Belgium, Luxembourg, United Kingdom, Republic of Ireland, Slovenia, Costa Rica, Argentina, Brazil, Dominican Republic, Taiwan, Korea, Greece, Mexico, Italy, Uruguay, Paraquay, Yugoslavia, New Zealand, India, Venezuela, South America, Norway, Sweden, Denmark, Turkey, Great Britain, Israel, Spain, Portugal, Greece, Korea, China, and Japan. | Details |
| Devices | Stingray Surgical Products, LLC | Class II | Ongoing | Worldwide Distribution - USA (nationwide) | Details |
| Devices | Stryker Howmedica Osteonics Corp. | Class II | Ongoing | Nationwide. | Details |
| Veterinary | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Class II | Ongoing | Distributed to Veterinary Clinics and Veterinarians by perscription Nationwide and Internationally to Hong Kong, Trinidad, Grand Cayman Islands, and Columbia. | Details |
| Devices | B. Braun Medical, Inc. | Class I | Ongoing | Nationwide Distribution-including Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI. | Details |
| Devices | GE Healthcare, LLC | Class II | Ongoing | Worldwide Distribution -- USA (nationwide) including the states of AK, CA, IL, MS, NJ, PR, SD, TN, TX, and VA. and the countries of ARGENTIAN, AUSTRALIA, BELGIUM, CHINA, GERMANY, ALGERIA, ECUADOR, EGYPT, FINLAND, UNITED KINGDOM, JORDAN, JAPAN, MOROCCO, MAURITUS, NETHERLANDS, OMAN, PERU, SEBIA, SUDI ARABIA, SINGAPORE, EL SALVADOR, TURKEY, URUGUAY and SOUTH AFRICA. | Details |
| Devices | Critical Diagnostics | Class III | Terminated | USA including the state of California and the countries of Austria, Spain, United Kingdom, and Italy. | Details |
| Devices | Teleflex Medical | Class II | Ongoing | Worldwide Distribution - U.S. (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Chile, China, Europe, India, Japan, Mexico, South Korea, Taiwan and UK. | Details |
| Devices | Alere San Diego, Inc. | Class II | Ongoing | US Nationwide Distribution | Details |
| Food/Cosmetics | SunOpta Ingredients Group (Corporate HQ) | Class II | Ongoing | Arizona, Michigan, Virginia, and Holland Recall expanded on 6/19/12 to include California. | Details |
| Devices | Abbott Molecular | Class II | Ongoing | California, Florida, Maryland, Oregon and Virginia, and internationally to Belgium, Brazil, China, France, Germany, Hong Kong, Japan, Malaysia, Mexico, Qatar, Switzerland and United Kingdom | Details |
| Food/Cosmetics | Truitt Bros., Inc. | Class II | Ongoing | Product was directly distributed to California, Oregon, and Washington. | Details |
| Devices | LMA North America Inc | Class II | Completed | Worldwide Distribution--USA (nationwide) and the countries of Canada, United Kingdom, ZA, and Australia. | Details |
| Food/Cosmetics | Itoen (USA) Inc | Class II | Ongoing | CA | Details |
| Devices | CareFusion 203, Inc. | Class I | Ongoing | Nationwide Distribution including AZ, CA, CO, FL, IL, KY, ME, MI, MO, MN, MT, ND, NJ, NM, NV, NY, OK, PA, SC, SD, TX , UT, WI, and WV. | Details |
| Devices | Hitachi Medical Systems America Inc | Class II | Ongoing | US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX. | Details |
| Devices | GE OEC Medical Systems, Inc | Class II | Ongoing | Worldwide Distribution. | Details |
| Devices | Gulf Fiberoptics, Inc. | Class II | Ongoing | Worldwide distribution: USA (nationwide) including states of: AL, CA, CO, FL, MI, NC, NJ, NY, OH, PA, TN, TX and WI and country of: South Africa. | Details |
| Devices | Varian Medical Systems, Inc. Oncology Systems | Class II | Ongoing | Worldwide distribution: USA (nationwide) and countries including of: Austria, Australia, Bahrain, Belgium, Brazil, Canada, China, Chile, Colombia, Denmark, Egypt, Finland, France,Germany, Greece, Hungary, Hong Kong, India, Indonesia, Israel, Ireland, Italy, Japan, Latvia, Malaysia, Mexico, Morocco, Nepal, Netherlands, Norway, Panama, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, United Kingdom, Taiwan, Turkey, Ukraine, United Arab Emirates and Venezuela. | Details |
| Devices | Spacelabs Healthcare, Llc | Class II | Ongoing | Worldwide Distribution - USA including Florida, Iowa, Oklahoma, South Caroline and the countries of India, Germany and Panama. | Details |
| Devices | Kimberly-Clark Corporation | Class II | Terminated | Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA | Details |
| Devices | DeRoyal Industries Inc | Class II | Ongoing | Nationwide Distribution including SD and NE. | Details |
| Devices | Integra Limited | Class II | Ongoing | USA (nationwide) including the states of AZ, CA, IL, MA, MN, NJ, OK, TN, TX, VA, WA and WI. | Details |
| Food/Cosmetics | Standard Process, Inc. | Class I | Ongoing | AL, AZ, AR, CA,CO, CT, DE, DC, FL,GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NY, NH,NM, NY, NC, OH, OK, PA, RI,SC, TN,TX,VT, VA, WA, WV, WI. | Details |
| Drugs | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals | Class III | Ongoing | Nationwide | Details |
| Devices | GE Healthcare, LLC | Class II | Ongoing | Worldwide Distribution (USA) nationwide | Details |
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