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

Enforcement Report - Week of July 18, 2012

  • Print
  • Share
  • E-mail
-
Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics American National Red Cross (The) Class II,Class III Terminated Ohio Details
Biologics Blood Bank of San Bernardino and Riverside Counties Class II Terminated California Details
Biologics Aultman Hospital Blood Bank Class III Terminated OH Details
Biologics American National Red Cross (The) Class II Terminated OH Details
Biologics Hoxworth Blood Center University of Cincinnati Medical Center Class III Terminated OH Details
Biologics Blood Centers of the Pacific Class III Terminated CA Details
Biologics CSL Plasma, Inc. Class II Terminated IL Details
Biologics Blood Centers of the Pacific Class II Terminated CA Details
Biologics Blood Centers of the Pacific Class II Terminated CA Details
Biologics Blood Centers of the Pacific Class II Terminated CA Details
Biologics Blood Centers of the Pacific Class III Terminated CA Details
Biologics Blood Centers of the Pacific Class II Terminated CA Details
Biologics BioLife Plasma Services L.P. Class II Terminated California Details
Biologics Hoxworth Blood Center University of Cincinnati Medical Center Class II Terminated IN Details
Food Wang Globalnet Class II Ongoing CA, TX, and NM. Details
Food Pro Nutech Inc. Class I Ongoing The recalled peanut products were distributed to two (2) customers: Country Oven Bakery, Bowling Green, KY and Smith's Bakery, Layton, UT. Details
Food KOREAN FARM, INC. Class II Ongoing Nationwide in the US. Details
Devices Edwards Lifesciences, LLC Class II Ongoing Worldwide Distribution - US (nationwide) including the states of CT, TX, CA, AZ, MO, and MD and the countries of Europe and Japan. Details
Biologics Delta Blood Bank Class II Terminated CA, Austria Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide distribution: USA (nationwide) and countries including: 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, Thailand, Turkey, United Arab Emirates (UAE), and Vietnam. Details
Devices Advanced Neuromodulation Systems Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom. Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide Distribution-USA (nationwide) 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, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam. Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV. Internationally to: Republic, Egypt, Germany, Guatamala, Honduras, Hong Kong, India, Indonesia, 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 Encision, Inc. Class II Ongoing Worldwide Distribution - USA including CA, TX, GA, NY, NC, OH), and New Zealand. Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of CA, FL, IL, MA, NJ, NY, SC, and TX and the countries of TURKEY, TUNISIA, TAIWAN, SPAIN, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, KENYA, JAPAN, ITALY, IRELAND, INDIA, GREAT BRITAIN, GERMANY, FRANCE, EGYPT, CHILE, CHINA, CANADA, BRAZIL, BELGIUM, AUSTRIA, and ARGENTINA. Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated Florida Details
Biologics American Red Cross Blood Services Class III Terminated Nebraska Details
Biologics American National Red Cross (The) Class III Terminated Oregon Details
Biologics American National Red Cross Class II,Class III Terminated Puerto Rico; California Details
Biologics Belle Bonfils Memorial Blood Center Class II Terminated Colorado Details
Biologics Belle Bonfils Memorial Blood Center Class II Terminated Colorado Details
Biologics Belle Bonfils Memorial Blood Center Class II Terminated Colorado Details
Biologics Belle Bonfils Memorial Blood Center Class II Terminated Colorado Details
Biologics New York Blood Center, Inc. Class II Terminated New York Details
Devices Civco Medical Instruments Inc Class II Ongoing Worldwide Distribution - USA including WI, CA, MA, IN, WA, and NJ. Foreign distribution was made to Germany, Canada, Denmark, Hong Kong, Ukraine, Japan, Italy, Korea, and France. Details
Devices Atom Medical Corporation Class II Ongoing Worldwide Distribution - USA including PA. Internationally to Japan, Kuwait, Saudi Arabia, Lenanon, Italy, Spain, China, East Europe, Slovakia, Poland, Czech Republic, Ukraine, Egypt, Russia, Algeria, Colombia, Germany, Malaysia, Switzerland, Australia, Europe, Portugal, Iran, Israel, Philippines, UAE, Korea, and Netherlands Details
Veterinary Solid Gold Hlth Prods For Pets, Inc. Class I Ongoing Distributed to Canada and following US States CA, IL, NY, OH, MI, WA, NV, FL, GA, NJ, PA, AZ, WI, HI, LA, OK, and TX. Canada: 1. Lucid, 5888 Trapp Ave, Burnaby B.C. V3N 5G4 2. 11 Edvac Dr. Units 8 & 9, Brampton, Ontario L6S 5W5 No Mexico. One Foreign: 56 Tannery Ln. Singapore 347801 Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated Florida Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated Georgia Details
Biologics Lifesouth Community Blood Centers, Inc. Class II Terminated Alabama Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated Georgia Details
Devices Argon Medical Devices, Inc Class II Ongoing Distributed only in Missouri. Details
Biologics Community Blood Council of New Jersey, Inc. Class II Terminated New Jersey Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated Alabama Details
Food H & L Jerch Sales, Inc. Class III Ongoing Nationwide Details
Biologics Medic Inc Class II Terminated Tennessee Details
Biologics American National Red Cross Great Lakes Region Class II Terminated California Details
Biologics Central California Blood Center Class II Terminated Maryland Details
Biologics Central California Blood Center Class II Terminated California Details
Veterinary Yachere Feed, Inc. Class II Ongoing Direct sales to farms in Fayette and Somerset Counties in PA, 1 direct account located in MD. Details
Biologics New York Blood Center, Inc. Class III Terminated New York Details
Biologics Blood Systems, Inc. dba United Blood Services Class II Terminated Texas Details
Biologics Carter BloodCare Class II,Class III Terminated Switzerland; Texas Details
Biologics American Red Cross Blood Services Class III Terminated California Details
Biologics South Bend Medical Foundation, Inc. Class II Terminated Indiana Details
Biologics Community Blood Center of Carolinas Class II Terminated North Carolina Details
Biologics Inland Northwest Blood Center Class II Terminated Florida Details
Biologics Department of Air Force - BB/HT Class II Terminated Texas Details
Biologics LifeSouth Community Blood Centers Inc - Birmingham Region Class II Terminated Alabama Details
Biologics LifeSouth Community Blood Centers Inc - Birmingham Region Class II Terminated Alabama Details
Devices Stryker Howmedica Osteonics Corp. Class II Ongoing Nationwide Distribution Details
Devices Alere San Diego, Inc. Class I Ongoing Nationwide Distribution Details
Biologics Blood Bank Of San Bernardino And Riverside Counties Class II Terminated California Details
Biologics DCI Biologicals Flagstaff LLC Class II Terminated Pennsylvania Details
Biologics Mid-South Regional Blood Center Class II Terminated Tennessee Details
Devices PSC Industries Inc Class II Ongoing Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines. Details
Drugs Noven Pharmaceuticals, Inc. Class II Ongoing Nationwide and Puerto Rico Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution -- Nationwide Distribution including the states of AZ, OR, PA and TX and the countries of Australia, Belgium, Canada, Denmark, Finland, France, Germany, India, Indonesia, Israel, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, and United Kingdom. Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, FL, GA, IA, IN, MI, NC, NJ, NY, OK, PA, SC, TN, TX, and WA and the countries of Australia, Austria, Canada, China, Czech Republic, Denmark, and France. Details
Devices GE OEC Medical Systems, Inc Class I Completed Worldwide Distribution - US (nationwide) Details
Devices Arjo, Inc. dba ArjoHuntleigh Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, Bermuda, Canada, Cyprus, Czech Republic, Denmark, Dubai, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Kenya, Korea, Luxembourg, the Netherlands, New Zealand, Northern Ireland, Norway, Poland, Portugal, Quatar, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland and Turkey Details
Devices Maquet Cardiovascular Us Sales, Llc Class I Ongoing Worldwide distribution: USA (nationwide) state of GA only and countries of: Argentina, Australia, Austria, Belgium, China, Czech Republic, Ecuador, Finland, France, Germany, India, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Africa, Spain, Sweden incl Maquet Critical Care, Switzerland, Thailand, United Arab Emirates, and United Kingdom. Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution - US (nationwide) including the states of: AR, LA, MI, NC, NY, OH, OK and PA and the countries of: Australia, Canada, Denmark, France, Germany, Israel, Netherlands, Spain and Switzerland. Details
Food Coca-Cola Refreshments, USA Inc. Class II Ongoing MO, IA and IL. Details
Devices Integra LifeSciences Corp Class II Completed International Only Distribution, including the countries of Thailand and Japan. Details
Food Mutual Trading Company Inc Class I Completed California Details
Veterinary Manna Pro Corp Class III Ongoing AZ, CO, MT, UT, CA, NV, OR, MO, WI, IL, MN, TX, AR, FL, PA, NY, VA Details
Devices Impac Medical Systems Inc Class II Ongoing Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom. Details
Food Snyder's - Lance Inc. Class II Ongoing AL, AR, AZ, FL, GA, IL, IN, KY, LA, MD, ME, MI, MO, MS, NC, NM, PA, SC, TN, TX, VA and WV. Details
Food Pacific Giant, Inc Class II Ongoing nationwide Details
Food Winter Gardens Quality Foods Inc Class II Ongoing DE, PA, MD, VA Canada Details
Devices Abbott Point Of Care Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) Details
Devices Zimmer, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of: Austria, Australia, Belgium, France, Gelmany, Italy, Spain, Switzerland and the United Kingdom. Details
Food Inventure Foods Class II Ongoing Nationwide in the US and in Canada Details
Devices PSC Industries Inc Class II Ongoing Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI. Details
Food Wanchese Fish Company Class II Ongoing Product were distributed to NY, SC, KS, PA, DE, TN, NC, FL, NJ, AL, and VA. Details
Devices Philips Healthcare Inc. Class II Ongoing Worldwide Distribution - USA including FL, IN, MA, M, NY, OH, TN, TX, and VA. Internationally to AUSTRALIA, HONG KONG, and INDIA Details
Food Minnesota Best Maid Cookie Co, Inc. Class II Ongoing FL, KY, MI, OH Details
Devices Stryker Endoscopy Class II Ongoing Worldwide Distribution--USA (nationwide) Details
Food Cosmo's Food Products, Inc. Class II Terminated AZ, AR, TN, GA, TX, WI, IL, NC, SC, VA, WV, OH, KY, AL, NJ, MD, CO, WY, MI, IN, UT, ID, FL, KS, MO, NE, NV, MN, SD, OK, OR, WA, MO, PA, Details
Food Henrys Farm Inc. Class I Ongoing Product was distributed to MD, VA and Washington, D.C. Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide distribution: USA (nationwide) and countries including: Germany, 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 Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatamala, 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
Food LEASA Industries Co., Inc. Class I Ongoing Distributed to retail wholesalers and distributors in Florida. Details
Food Coca-Cola Refreshments USA, Inc. Class II Ongoing TX Details
Devices superDimension, Inc Class II Ongoing Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, and Wisconsin and the countries of Canada, Australia, Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom. Details
Devices Smiths Medical ASD, Inc. Class II Ongoing US Nationwide Distribution Details
Drugs GlaxoSmithKline Inc Class II Ongoing Nationwide Details
Food Dole Fresh Vegetables Inc Class I Ongoing VA, NC. KY. SC. TN. GA Details
Devices GE OEC Medical Systems, Inc Class II Terminated Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA Details
Drugs VistaPharm, Inc. Class II Ongoing Nationwide Details
Devices Cardiovascular Systems, Inc. Class II Ongoing Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX. Details
Food Giusto's Specialty Foods LLC Class II Ongoing CA, HI, WA. Details
Drugs Kimberly-Clark Corporation Class II Ongoing Nationwide and Canada Details
Food Banner Mountain Sprouts Inc Class I Ongoing CA Details
Devices Elekta, Inc. Class II Ongoing Nationwide Distribution including CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI. Details
Devices Elekta, Inc. Class II Ongoing US Nationwide Distribution - including the states of: CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI Details
Drugs ASTRA ZENECA Lp Class III Ongoing Nationwide. Details
Devices Vital Signs Devices, a GE Healthcare Company Class II Ongoing Nationwide Distribution. Details
Food Dole Fresh Vegetables Inc Class I Ongoing AL, FL, GA, MD, NC, PA, SC, TN and VA Details
Devices Draeger Medical Systems, Inc. Class II Ongoing Nationwide Distribution-USA (nationwide) and Puerto Rico. Details
Food Fruiti Pops Inc. Class I Ongoing Per firm, the product is distributed in Southern Califormia and are sold by push cart vendors and ice cream trucks. Details
Food Rhee Brothers Incorporated Class II Ongoing The product was distributed nationwide. Details
Drugs Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals Class III Ongoing Nationwide and Puerto Rico. Details
Food Pacific International Marketing Class I Ongoing CA and NV Details
-
-