Enforcement Report - Week of August 15, 2012
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| Product Type | Recalling Firm | Classification | Status | Distribution Pattern | Event Details |
|---|---|---|---|---|---|
| Biologics | Community Blood Center of Greater Kansas City | Class II | Terminated | MO | Details |
| Biologics | Community Blood Center of Greater Kansas City | Class III | Terminated | MO | Details |
| Biologics | Community Blood Center of Greater Kansas City | Class III | Terminated | MO | Details |
| Biologics | Community Blood Center of Greater Kansas City | Class III | Terminated | MO | 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 | Details |
| Biologics | CSL Plasma Inc | Class II | Terminated | IL, NC | Details |
| Biologics | American National Red Cross (The) | Class II | Terminated | OH | Details |
| Biologics | ZLB Bioplasma, Inc. | Class II | Terminated | IL | Details |
| Biologics | American National Red Cross (The) | Class II | Terminated | KY, OH, IN | Details |
| Biologics | American National Red Cross (The) | Class II | Terminated | KY | Details |
| Biologics | Community Blood Center | Class II | Terminated | OH | Details |
| Biologics | Hoxworth Blood Center University of Cincinnati Medical Center | Class II | Terminated | OH and KY | Details |
| Biologics | Talecris Plasma Resources, Inc. | Class II | Terminated | NC | Details |
| Food/Cosmetics | Designer Protein LLC | Class II | Ongoing | nationwide in the US and worldwide to Philippines and Brazil. | Details |
| Food/Cosmetics | Southwind Foods LLC dba Great American Seafood Imports Co. | Class II | Ongoing | Nationwide | Details |
| Biologics | Interstate Blood Bank Inc | Class II | Terminated | CA | Details |
| Biologics | CSL Plasma, Inc. | Class II | Terminated | IL, Switzerland, Germany, North Carolina | Details |
| Food/Cosmetics | Gills Onions, LLC | Class I | Ongoing | Nationwide in the US and to Canada | Details |
| Veterinary | Central Garden & Pet Company | Class I | Ongoing | Nationwide including Puerto Rico. OUS to include: Australia, Canada, China, Dominican Republic, Guam, Hong Kong, Japan, Korea, Mexico, New Zealand, South Africa, and Thailand. | Details |
| Veterinary | Land O Lakes Purina LLC | Class I | Terminated | The feed was distributed in IA. | Details |
| Drugs | Hospira Inc. | Class I | Ongoing | Nationwide. | Details |
| Food/Cosmetics | River Ranch Fresh Foods LLC | Class I,Class II | Ongoing | Products were released for distribution in US and Canada. | Details |
| Biologics | Blood Assurance Inc | Class II | Terminated | TN, GA, NY | Details |
| Biologics | Blood Assurance Inc | Class II,Class III | Terminated | GA, IN | Details |
| Biologics | Central California Blood Center | Class II | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | LifeServe Blood Center | Class II | Terminated | IA and FL | Details |
| Biologics | American National Red Cross (The) - North Central Region | Class II | Terminated | MN | Details |
| Devices | SCC Soft Computer | Class II | Ongoing | US Nationwide Distribution | Details |
| Biologics | So Ca Permamente Med Group Blood Donor Cntr | Class II | Terminated | CA | Details |
| Biologics | Florida's Blood Centers, Inc. | Class II | Terminated | FL | Details |
| Food/Cosmetics | Altura Food, Inc. | Class I | Ongoing | Puerto Rico- Only one consignee | Details |
| Drugs | Teva Pharmaceuticals USA, Inc. | Class II | Ongoing | Nationwide | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Interstate Blood Bank, Inc. WI | Class III | Terminated | CA | Details |
| Biologics | Plasma Biological Services, Inc | Class II | Terminated | NC | Details |
| Biologics | Blood Center of Northcentral Wisconsin, Inc. | Class II | Terminated | WI | Details |
| Biologics | Walter L. Shepeard Community Blood Center, Inc. | Class II | Terminated | GA | Details |
| Devices | Angiodynamics Worldwide Headquarters | Class II | Ongoing | Worldwide distribution: USA (nationwide) including states of: CA, KS, MO, and NC and countries of: Czech Republic and Switzerland. | Details |
| Biologics | New York Blood Center, Inc. | Class II | Terminated | New York | Details |
| Biologics | Florida's Blood Centers, Inc. | Class III | Terminated | Florida | Details |
| Biologics | Talecris Plasma Resources, Inc. | Class III | Terminated | North Carolina | Details |
| Biologics | Memorial Blood Centers | Class III | Terminated | Minnesota | Details |
| Biologics | Memorial Blood Centers | Class II | Terminated | Minnesota | Details |
| Devices | Biomet 3i, LLC | Class II | Ongoing | Worldwide Distribution -- United States, UK, France, Canada, Mexico, Poland, Lebanon and Hong Kong. | Details |
| Devices | Linvatec Corp. dba ConMed Linvatec | Class II | Ongoing | Nationwide Distribution, including the states of Colorado and Pennsylvania. | Details |
| Devices | Siemens Healthcare Diagnostics, Inc. | Class II | Ongoing | USA (nationwide) including the states of AZ, CA, MS, MO, NJ, NC, OH, OR, PA, and TX. | Details |
| Biologics | South Texas Blood & Tissue Center | Class II | Terminated | Austria, Florida, Texas | Details |
| Devices | GE OEC Medical Systems, Inc | Class I | Completed | Worldwide Distribution - USA including MO, IL, LA, FL, NH, TX, IN, PA, NJ and the countries of France and China | Details |
| Devices | Stryker Spine | Class II | Ongoing | Nationwide Distribution including NC, AR, TN, MA, IL, GA, NY, LA, MN, MO, OH, KS, NM, TX, KS,and IN. | Details |
| Drugs | Apotex Corp. | Class II | Ongoing | Nationwide | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Japan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam. | Details |
| Devices | Siemens Healthcare Diagnostics, Inc. | Class II | Ongoing | Worldwide distribution, including the countries of Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, New Zealand, Slovakia, Spain, Switzerland and the United States, with nationwide distribution. Center Recall Depth is Retail. | Details |
| Devices | Roche Molecular Systems, Inc. | Class III | Ongoing | Worldwide Distribution - including the countries of Austria, Belgium, Czech Republic, Denmark, Germany, Italy, Luxemburg, Netherlands, Poland, Slovakia, Slovenia, Spain, United Kingdom, Canada, Chile, Greenland, Hong Kong, Israel, Malaysia, New Zealand, Philippines, S. Africa, Switzerland, Taiwan and Turkey. | Details |
| Devices | Tango3 LLC | Class II | Ongoing | Product was shipped to the following states: CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, NH, NJ, NM, OH, PA, RI, TX and VA. | Details |
| Devices | Smith & Nephew, Inc. Endoscopy Division | Class II | Ongoing | Worldwide Distribution - US Nationwide and the countries of: Argentina, AUSTRALIA, AUSTRIA, Belgium, CANADA,CHILE COLOMBIA, Denmark, DUBAI, FINLAND, FRANCE GDC BAAR Distribution,GERMANY, GREECE, INDIA ITALY, KOREA, MALAYSIA, MEXICO, NETHERLAND, NORWAY PORTUGAL, PUERTO RICO, SHANGHAI, SOUTH AFRICA SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM. | Details |
| Devices | Abbott Point Of Care Inc. | Class II | Ongoing | Worldwide Distribution - USA including AZ and CO and internationally to Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Chile, China, Columbia, Costa Rica, Dominican Republic, El Salvador, Finland, France, Georgia, Germany, Greece, Honduras, Hong Kong, India, Ireland, Italy, Korea, Kuwait, Mauritius, Mexico, Netherland (Antilles), Nigeria, Norway, Oman, Paraquay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, R.O.C., Thailand, UAE, United Kingdom, and Yemen. | Details |
| Devices | Impact Instrumentation, Inc. | Class III | Ongoing | US Distribution to the state of Illinois. | Details |
| Devices | Abbott Point Of Care Inc. | Class II | Ongoing | Worldwide Distribution -- (USA) nationwide | Details |
| Food/Cosmetics | Two Chefs On A Roll, Inc | Class II | Ongoing | Product is manufactured for and distributed to Maya Kaimal Fine Indian Foods, 4755 27th Street, Long Island City, NY (PO Box 700, Rhinebeck, NY 12572). Secondary distribution to accounts in CT, MA, ME, NH, NJ, NY, RI and VT. | Details |
| Devices | Philips Healthcare Inc. | Class II | Ongoing | Worldwide Distribution - US (nationwide) including the states of CA, CT, MI, MN, MN, NC, NY, NY, VA and the countries of Belgium, Columbia, Czech Republic and Denmark. France Germany Italy Latvia Luxembourg Netherlands Russian Fed. Spain Sweden Switzerland Thailand United Kingdom | Details |
| Devices | FMS, Finapres Medical Systems BV | Class II | Ongoing | US Nationwide Distribution - including the states of: OH and NY | Details |
| Devices | Baxter Healthcare Corp. | Class I | Ongoing | Worldwide Distribution - USA - Nationwide including Puerto Rico, and internationally to Brazil, Canada, Colombia, Costa Rica, Czech Republic, El Salvador, Egypt, Germany, Guatemala, Honduras, Luxembourg, Mexico, Panama, Saudi Arabia, Singapore, Switzerland, Taiwan, Trinidad, Turkey, United Arab Emirates and United Kingdom. | Details |
| Devices | Encore Medical, Lp | Class II | Ongoing | Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT. | Details |
| Devices | Varian Medical Systems, Inc. Oncology Systems | Class II | Ongoing | Nationwide Distribution including the states of New York and Ohio. | Details |
| Devices | Straumann USA, LLC | Class II | Ongoing | US Nationwide Distribution including the countries of FL, IN, LA, NY and TX. | Details |
| Devices | Transenterix, Inc | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and the countries of Austria, Germany, Italy, Qatar and Switzerland | Details |
| Devices | Greiner Bio-One North America, Inc. | Class II | Ongoing | Nationwide Distribution | Details |
| Devices | Kimberly-Clark Corporation | Class II | Ongoing | Nationwide Distribution-including the states of AZ, CA, CO, DE, FL, GA, IA, ID, IN, IL, KS, KY, LA, MA, MD, ME, MO, MS, NE, NM, OH, OR, PA, RI, SC, TN, TX, VA, WI and WV. | Details |
| Drugs | Nephron Pharmaceuticals Corp. | Class II | Ongoing | Nationwide and Puerto Rico | Details |
| Devices | Siemens Healthcare Diagnostics, Inc. | Class III | Ongoing | Worldwide Distribution -- US, including Washington, DC and the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WV, and the countries of Canada, New Zealand, Germany, and Puerto Rico. | Details |
| Devices | Siemens Healthcare Diagnostics, Inc. | Class II | Ongoing | Distributed in the US including Washington, DC, 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, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WI, WV, and WY and the Virgin and Pacific Islands. | Details |
| Food/Cosmetics | Pal-Do Company, Inc d.b.a. Pal-Do World | Class II | Ongoing | Product was distributed to one consignee in Lakewood, WA. | Details |
| Devices | Smith & Nephew, Inc. Endoscopy Division | Class II | Ongoing | Worldwide Distribution - US Nationwide and the countries of : Australia, Canada, Korea, Turkey, UAE, and Japan. | Details |
| Devices | Stryker Spine | Class II | Ongoing | Worldwide Distribution -- US, Switzerland, Netherlands, Brazil, Hong Kong, Germany, and Taiwan. | Details |
| Food/Cosmetics | Naturex Inc. | Class III | Ongoing | 1 firm in New Jersey and 1 firm in South Carolina | Details |
| Devices | Linvatec Corp. dba ConMed Linvatec | Class II | Completed | Worldwide Distribution -- US and Korea. | Details |
| Food/Cosmetics | Shah Distributors | Class I | Ongoing | Northern CA only. | Details |
| Food/Cosmetics | Mount Franklin Foods LLC | Class I | Ongoing | AZ, CA, KY, OK, and VA. | Details |
| Food/Cosmetics | GH Foods CA LLC | Class I,Class II | Ongoing | CA, NV, AZ, UT, AZ, CO, NM, SD, WY, NE. | Details |
| Food/Cosmetics | Ken's Foods, Inc. | Class I | Ongoing | AL,FL,GA,IL,KY,MS,NC,NE,NM,NV,OH,OK,SC,TN,TX,WI | Details |
| Devices | Berchtold Corp. | Class III | Ongoing | Nationwide Distribution including FL, MI, MS, and NH. | Details |
| Food/Cosmetics | Fahman Enterprises, Inc | Class I | Ongoing | Products were distributed to the states of Texas, Kansas, and Arkansas | Details |
| Drugs | Oklahoma Respiratory Care Inc | Class II | Completed | OK | Details |
| Food/Cosmetics | FreshPoint Central Florida | Class I | Ongoing | Onion products were distributed to restaurant/food service in FL only. | Details |
| Food/Cosmetics | High Liner Foods Inc. | Class II | Terminated | Nationwide | Details |
| Food/Cosmetics | San Miguel Produce, Inc. | Class I | Ongoing | Distributed to AZ, CA, IA, and NV. | Details |
| Food/Cosmetics | Nuts and Spice Co., Inc. | Class I | Ongoing | Northern CA, and one customer in WA, NV, UT. | Details |
| Devices | Medical Specialties Distributors, Inc. | Class II | Ongoing | Nationwide Distribution | Details |
| Food/Cosmetics | FreshPoint South Florida | Class I | Ongoing | Products were distributed in South Florida. | Details |
| Food/Cosmetics | Keys Fisheries, Inc. | Class I | Ongoing | Product was distributed to Whole Food Stores in Florida. | Details |
| Food/Cosmetics | SJBW Corp | Class II | Terminated | CA, NV, GA, WA | Details |
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