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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics ZLB Bioplasma, Inc. Class II Terminated IL, IN, Germany, Switzerland Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated FL, Austria Details
Biologics Community Blood Center of Greater Kansas City Class III Terminated Missouri Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated NE Details
Biologics Mary Greeley Medical Center Class II Terminated IA, NY, MO Details
Biologics Community Blood Center of Greater Kansas City Class III Terminated MO Details
Biologics Mercy Medical Center Blood Bank Class II Terminated IA, Details
Biologics Community Blood Center of Greater Kansas City Class II Terminated KS Details
Biologics Community Blood Center Of Gtr KC Class III Terminated Kansas Details
Biologics Community Blood Center Of Gtr KC Class III Terminated MO. Details
Biologics American National Red Cross (The) Class III Terminated California Details
Biologics American National Red Cross (The) Class II Terminated CO, NE, Switzerland Details
Biologics Mississippi Valley Reg Bld Ctr Class III Terminated Iowa, Missouri, New York. Details
Biologics Community Blood Center Of Gtr KC Class III Terminated Kansas. Details
Biologics Community Blood Bank of Lancaster County Medical Society Class III Terminated Austria; FL; NE Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II,Class III Terminated NE; OH; TN; MO; Austria Details
Biologics American National Red Cross (The) Class II,Class III Terminated NE Details
Biologics American Red Cross Blood Services Class III Terminated unknown Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II,Class III Terminated MO; Austria Details
Biologics Mississippi Valley Regional Blood Center Class II Terminated Iowa, Illinois Details
Biologics American National Red Cross (The) Class II Terminated CA, MA Details
Biologics One Lambda Inc Class II Terminated US States CA and NY. Nationwide to: Canada, United Kingdom, Germany, Israel, Spain, Japan, Singapore, and vietnam. Details
Biologics One Lambda Inc Class II Terminated Nationwide in the US: OR and IL, and worldwide to Canada, Saudi Arabia/USA, United Kingdom, Germany, Italy, Jordon, Sweden, and Peru. Details
Biologics CSL Plasma, Inc. Class II Terminated IL, Switzerland, Germany Details
Biologics Octapharma Plasma, Inc. Class III Terminated CA, Austria Details
Biologics BloodSource, Inc. Class II Terminated CA, Austria Details
Biologics Delta Blood Bank Class II Terminated CA. Details
Biologics Delta Blood Bank Class III Terminated IN. Details
Biologics Delta Blood Bank Class II Terminated CA. Details
Food McClures, Inc. Class I,Class II Ongoing Product was distributed to retail outlets in DE, MD, NJ and PA within the US. Details
Drugs www.vitaminbestbuy.com Class I Ongoing Nationwide Details
Biologics Blood Centers of the Pacific - Irwin Center Class II Terminated Switzerland; Austria; Armed Forces Americas, California Details
Biologics Walter L. Shepeard Community Blood Center, Inc. Class II Terminated Georgia Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide and US Nationwide Distribution Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of AUSTRALIA, Singapore, Jordan, Japan, Vietnam, Germany, Russia, Saudi Arabia, BELGIUM, Mexico, and CANADA. Details
Drugs Watson Laboratories, Inc. Class II Ongoing Nationwide Details
Devices Alcon Research, LTD. Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Greece, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria. Details
Drugs Ben Venue Laboratories Inc Class I Ongoing Nationwide Details
Devices Clark Laboratories, Inc. (dba,Trinity Biotech USA) Class III Ongoing Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX. Details
Food Haldeman Mills Class II Ongoing Product was distributed to specific wholesale and retail outlets within the State of Pennsylvania Details
Devices OPTI Medical Systems, Inc Class II Ongoing Worldwide Distribution -- US (nationwide) including the states of AZ, ID, TX and UT., and the countries of Argentina, Bolivia, China, Ecuador, France, Germany Greece, India, Indonesia, Iran, Ireland, Japan, Kuwait, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Nigeria, Poland, Romania, Russia, Saudi Arabia, Singapore, South Africa, Sudan Switzerland, Turkey, United kingdom, Venezuela, and Viet Nam. Details
Drugs Abbott Laboratories Class II Ongoing Nationwide Details
Drugs Mallinckrodt Inc Class III Ongoing AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK Details
Food Derby City Vending Inc Class I,Class II Ongoing Product was shipped to KY and IN. Details
Devices Imaging Sciences International, LLC Class II Ongoing Worldwide Distribution - USA including Washington, DC, AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and the country of Canada. Details
Drugs Bracco Diagnostics Inc Class II Ongoing Nationwide and United Kingdom Details
Drugs Mylan Pharmaceuticals Inc. Class II Completed The product was distributed to KY. Details
Food Triton Seafood Co. Class II Terminated Product was distributed throughout the state of Florida and Texas. Details
Devices Cordis Corporation Class II Completed Worldwide Distribution - USA and Germany Details
Devices Mc-NEIL-PPC, Inc. Class II Ongoing Nationwide Distribution Details
Devices Invacare Corporation Class II Ongoing Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of AUSTRALIA, CANADA, GUAM, ISRAEL, NEW ZEALAND, THAILAND, TRINIDAD AND TOBAGO. Details
Devices KCI USA, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria. Details
Food Pulmuone Wildwood Inc Class II Ongoing Nationwide and Canada. Details
Food MyoSci Technologies Inc. Class I Ongoing nationwide in the US and worldwide to Canada and United Kingdom. Details
Devices Linvatec Corp. dba ConMed Linvatec Class II Terminated Worldwide Distribution - US Nationwide and the countries of Canada, DK, HK, IN, IT, KR, MY, RU, CO, VN, ZA. Details
Food Cucina Fresca, Inc. Class I Ongoing Product was distributed to Oregon and Washington Details
Devices Covidien LP Class II Ongoing Worldwide Distribution. Details
Biologics Rocky Mountain Lions Eye Bank Class II Terminated Japan Details
Biologics Lions Eye Bank of Texas Class II Terminated Texas Details
Biologics Upstate New York Transplant Services Class II Terminated New York Details
Biologics RTI Biologics, Inc. Class II Terminated Oklahoma Details
Biologics RTI Biologics, Inc. Class II Terminated Arizona; Pennsylvania; South Carolina; Oregon; Maryland; California; Florida Details
Food Splendid Products Class I Ongoing Nationwide distribution. Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution - USA including AL, AZ, CA, CO, FL, GA, IL, KS, KY, MI, MS, NJ, NM, NV, NY, OH, TX, WA & WI and internationally to: Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, India, Italy, Japan, Jordan, Mexico, Saudi Arabia, South Korea, Spain, Thailand, Turkey & United Kingdom. Details
Food Meijer Distribution, Inc Class II Ongoing Up to 199 Meijer stores located in Illinois, Indiana, Kentucky, Michigan, and Ohio may have received product from Meijer distribution centers. Details
Biologics Viacord Processing Laboratory Class II Terminated New York Details
Biologics Lions Eye Institute for Transplant & Research, Inc. Class II Terminated California; Florida Details
Food Gordon Food Service Class I Ongoing restaurants and GFS retail outlets in Florida Details
Food Indalco Foods Corp. Class I Ongoing US Details
Food Ready Pac Foods Inc Class I Ongoing Nationwide to following US States and Canada: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Washington D.C., Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, Wyoming, and Canada. Details
Devices Alere San Diego, Inc. Class II Ongoing Nationwide Distribution. Details
Devices Abbott Vascular Class II Ongoing Nationwide(US) Distribution and Puerto Rico. Details
Devices Varian Medical Systems, Inc. Oncology Systems Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally. . . Details
Drugs Dispensing Solutions, Inc Class II Ongoing US: IN & WI Details
Devices Applied Medical Resources Corp Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa. Details
Devices Linvatec Corp. dba ConMed Linvatec Class II Ongoing Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA ,WI and Hawaii., and the countries of Australia Canada, China, Switzerland, Germany, Czech Republic, Denmark, Egypt, Spain, France, South Africa, United Kingdom, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Russia and Saudi Arabia. Details
Devices Philips Healthcare Inc. Class II Ongoing Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, Chile, Finland, France, Germany, Hungary. Italy, Japan, Latvia, Netherlands, New Zealand. Oman, South Korea, Switzerland and United Kingdom. Details
Devices Greatbatch Medical Class II Ongoing Distributed in MA. Details
Food M & K Trading Inc Class II Terminated California Details
Food Dawn Food Products, Incorporated Class I Ongoing To Sam's Club locations in UT, OK, TX CA, MO, and WY, USA. Details
Devices Neomend Inc Class II Terminated US Nationwide Distribution Details
Devices Toshiba American Medical Systems Inc Class II Terminated Nationwide distribution: USA including states of: MA, MD, and NV. Details
Devices Hologic, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia,Belgium, Canada, China, Germany, Ecuador, Spain, France, Great Britain, Greece, Hong Kong, Italy, Japan Korea, Lithuvania, Neherlands, qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan, South Africa, and Switzerland. Details
Devices RAYSEARCH LABORATORIES AB Class II Completed Worldwide Distribution - USA including CA, KY, MI, NY, OK, OR, SD, and WI. Internationalyl to Canada, Sweden, France, Germany, Australia, Poland, Belgium, and United Kingdom. Details
Devices Micro Therapeutics Inc, Dba Ev3 Neurovascular Class II Completed Worldwide Distribution - US Nationwide including the states: MN, FL, OR, TX and the countries of: Brazil, Belgium, Czech Republic, Finlind, France, Germany, Netherlands, Poland, and United Kingdom. Details
Drugs Baxter Healthcare Corp. Class II Ongoing Nationwide and Puerto Rico Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing Nationwide Distribution - USA including Washington, DC and AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI and Puerto Rico. Details
Drugs Hospira Inc. Class II Ongoing Nationwide Details
Drugs Glenmark Generics Inc., USA Class II Ongoing Nationwide Details
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