• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013

  • Print
  • Share
  • E-mail
-
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 Whole Foods Market Brand 365, Llc Class I Ongoing KY Details
Devices Zimmer, Inc. Class II Ongoing Worldwide Distribution Details
Food Maplehurst Deli-Bake South Inc Class I Ongoing FL & GA Details
Food Michael's Seafood Inc. DBA Michael's Gourmet & Delicacies Class I Ongoing Products was distributed in Florida. Details
Food Capital City Fruit Co. Class I Ongoing The product was distributed to IA, MO, NE, MN and WI. Details
Food 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 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 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 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 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 S & M International Inc Class II Ongoing Northeast Details
Food New B.C.N. Trading Inc Class III Ongoing CT, FL, NJ, NY, PA, & VA Details
Food 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 United National Foods (Unfi) Class I Ongoing Distributed to UNFI distribution centers located in WA, CA, CO, and TX. Details
-
-