Enforcement Report - Week of January 16, 2013
-
| Product Type | Recalling Firm | Classification | Status | Distribution Pattern | Event Details |
|---|---|---|---|---|---|
| Biologics | Biomat USA, Inc. | Class III | Terminated | Spain | Details |
| Biologics | Biomat USA, Inc. | Class III | Terminated | Spain | Details |
| Biologics | Biomat USA, Inc. | Class III | Terminated | Spain | Details |
| Biologics | Biomat USA, Inc. | Class III | Terminated | Spain | Details |
| Biologics | LifeServe Blood Center | Class III | Terminated | Iowa; Pennsylvania; CSL fractionator. | Details |
| Biologics | Biomat USA, Inc. | Class II | Terminated | California | Details |
| Biologics | Biomat USA, Inc. | Class II | Terminated | California | Details |
| Biologics | Biomat USA, Inc. | Class II | Terminated | California | Details |
| Biologics | Community Blood Center of the Ozarks | Class II | Terminated | Austria | Details |
| Biologics | Biomat USA, Inc. | Class II | Terminated | Austria | Details |
| Biologics | Puget Sound Blood Center | Class II | Terminated | Washington | Details |
| Biologics | Biomat USA, Inc. | Class II | Terminated | California, Spain | Details |
| Biologics | Talecris Plasma Resources, Inc. | Class II | Terminated | North Carolina | Details |
| Biologics | Puget Sound Blood Center and Program | Class II | Terminated | Washington | Details |
| Biologics | Puget Sound Blood Center and Program | Class II | Terminated | Washington | Details |
| Biologics | Talecris Plasma Resources, Inc. | Class II | Terminated | North Carolina | Details |
| Biologics | Talecris Plasma Resources, Inc. | Class II | Terminated | NC | Details |
| Biologics | Biomat USA, Inc. | Class II | Terminated | Spain | Details |
| Biologics | Talecris Plasma Resources, Inc. | Class III | Terminated | NC | Details |
| Biologics | Blood Centers of the Pacific | Class III | Terminated | CA | Details |
| Biologics | Delta Blood Bank | Class II | Terminated | CA | Details |
| Devices | Stryker Howmedica Osteonics Corp. | Class II | Ongoing | Nationwide distribution, including the states of NY, NJ, CA and FL. | Details |
| Devices | Maquet Cardiovascular, LLC | Class II | Ongoing | Worldwide Distribution - USA including ID and Fl and Internationally to United Arab Emirates, France, Luxembourg, Poland, Spain, Sweden, Germany, Italy, Netherlands, Republic of China, Spain, Sweden, and Thailand | Details |
| Devices | Zoll Circulation, Inc. | Class II | Ongoing | Worldwide distribution. | Details |
| Devices | Philips Medical Systems North America Co. Phillips | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and the countries of Japan and Malaysia. | Details |
| Biologics | Tissue Banks International | Class I | Terminated | Allograft products were released for distribution to 6 consignees in US. located in CA, MD and PA. | Details |
| Devices | Surgical Tissue Network, Inc. | Class II | Ongoing | Worldwide Distribution including Turkey, Greece, & Mexico. | Details |
| Biologics | Musculoskeletal Transplant Foundation | Class I | Terminated | AK, AZ, CA, MI, PA. TX | Details |
| Devices | Merit Medical Systems, Inc. | Class II | Completed | Distributed in Mississippi and New Jersey. | Details |
| Biologics | Community Blood Centers of Florida, Inc. | Class II | Terminated | Florida | Details |
| Biologics | Community Blood Centers of Florida, Inc. | Class II,Class III | Terminated | Tennessee; Switzerland; Florida | Details |
| Devices | Stryker Communications, Inc. | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and Internationally to Australia, Japan, Taiwan, Canada, United Kingdom, France, Netherlands, Spain, Mexico, India, Korea, Singapore, New Zealand, Hong Kong, Philippines and Brazil. | Details |
| Biologics | Puget Sound Blood Center and Program | Class II | Terminated | Washington; California | Details |
| Biologics | LifeShare Blood Centers | Class II | Terminated | Arkansas | Details |
| Biologics | LifeShare Blood Centers | Class III | Terminated | Louisiana | Details |
| Biologics | LifeShare Blood Centers | Class II | Terminated | Louisiana, Texas | Details |
| Food/Cosmetics | Whole Foods Market Brand 365, Llc | Class I | Ongoing | KY | Details |
| Devices | Zimmer, Inc. | Class II | Ongoing | Worldwide Distribution | Details |
| Food/Cosmetics | Maplehurst Deli-Bake South Inc | Class I | Ongoing | FL & GA | Details |
| Food/Cosmetics | Michael's Seafood Inc. DBA Michael's Gourmet & Delicacies | Class I | Ongoing | Products was distributed in Florida. | Details |
| Food/Cosmetics | Capital City Fruit Co. | Class I | Ongoing | The product was distributed to IA, MO, NE, MN and WI. | Details |
| Food/Cosmetics | Pastry Food Products Inc. | Class I,Class II | Ongoing | Puerto Rico only | Details |
| Devices | Siemens Healthcare Diagnostics Inc | Class II,Class III | Ongoing | Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong, | Details |
| Food/Cosmetics | Lifevantage Corp | Class II | Ongoing | Sale of products through a network of independent distributors, preferred customers and end consumers in the United States, Japan, Australia and Mexico. Sales also directly to end consumers for personal consumption in Canada. Independent distributors consume the product themselves and in some cases sell the product or provide the product gratis to those potentially interested in LifeVantage. Preferred customers purchase the products on a monthly, auto-ship basis directly from Life Vantage. Other end consumers purchase directly from LifeVantage via the website and are assigned to a distributor. | Details |
| Devices | Horiba Instruments, Inc dba Horiba Medical | Class II | Ongoing | Nationwide in the US, including the states of CA, MI, IN, FL, and GA. | Details |
| Devices | Applied Medical Resources Corp | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and France. | Details |
| Devices | Biomet, Inc. | Class II | Ongoing | Worldwide Distribution -- US (nationwide) including the countries of , Canada, Japan, Argentina, Australia ,Netherlands, Europe and Chile. | Details |
| Devices | Siemens Healthcare Diagnostics | Class III | Ongoing | Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan, and Uraguay, | Details |
| Devices | Advanced Sterilization Products | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and internationally to the following countries: AR, CO, TW, SI, AU, MX, MY, HU, PH, BE, FR, DE, IE, IT, ES, NO, CH, and GB. | Details |
| Food/Cosmetics | Meijer Distribution, Inc | Class III | Ongoing | 199 Meijer stores located in Illinois, Indiana, Kentucky, Michigan, and Ohio may have received product from Meijer distribution centers. | Details |
| Devices | Siemens Healthcare Diagnostics, Inc. | Class II | Ongoing | Distributed in the states of CA, FL, IL, KS, MA, MI, MN, MS, NM, NY, NC, OH, OR, PA, TN, TX, UT, and WA. | Details |
| Devices | California Medical Laboratories Inc | Class II | Ongoing | Worldwide Distribution - USA including AZ, FL, CA, LA, CO, and MS. Internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, Netherlands, Russia, Saudi Arabia, South Africa and Spain. | Details |
| Food/Cosmetics | Udi's Healthy Foods,Granola & Gluten Free | Class I | Ongoing | US Distribution: 5 direct accounts in WA, CA, CO with subaccount distribution to WA, CA, CO, NV, UT, MT, ID, and OR. | Details |
| Food/Cosmetics | Dawn Food Products, Inc. | Class II | Ongoing | Distribution Centers in GA, IL, Ca, TX, | Details |
| Devices | Concentric Medical Inc | Class II | Ongoing | US (nationwide) including the states of CA, FL, GA, OR and TN. | Details |
| Devices | Siemens Healthcare Diagnostics, Inc. | Class III | Ongoing | Nationwide Distribution to the following states: AL, AR, CA, CO, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NY, OH, PA, TN, TX and WI. | Details |
| Food/Cosmetics | S & M International Inc | Class II | Ongoing | Northeast | Details |
| Food/Cosmetics | New B.C.N. Trading Inc | Class III | Ongoing | CT, FL, NJ, NY, PA, & VA | Details |
| Food/Cosmetics | Multiexport Foods, Inc. | Class I | Ongoing | Alabama, Arkansas, Alaska, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Montana, Missouri, Mississippi, Nebraska, North Carolina, New Hampshire, New Jersey, New York, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Washington, Virginia, Wisconsin and West Virginia | Details |
| Food/Cosmetics | United National Foods (Unfi) | Class I | Ongoing | Distributed to UNFI distribution centers located in WA, CA, CO, and TX. | Details |
-
