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U.S. Department of Health and Human Services

Enforcement Report - Week of January 2, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Devices Radiometer America Inc Class III Completed Distributed to KY, NC, and NY. Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated NE Details
Biologics American National Red Cross Class II Terminated Idaho, Montana, and Utah and California Details
Biologics Community Blood Center of the Ozarks Class II Terminated Missouri Details
Biologics American National Red Cross (The) Class II Terminated Oregon and California Details
Biologics American National Red Cross Class II Terminated Oregon and Ohio Details
Biologics American National Red Cross (The) Class II,Class III Terminated PA Details
Biologics American National Red Cross Class II,Class III Terminated Oregon and Florida Details
Biologics American National Red Cross Class II Terminated Florida, Oregon, and Washington Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated NY Details
Biologics International BioResources, LLC Class II Terminated NC Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated NJ Details
Biologics American National Red Cross (The) Class II Terminated OH and PA Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated NE Details
Biologics Community Blood Center of the Ozarks Class II Terminated Missouri Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Missouri and Indiana Details
Biologics Community Blood Center Of Gtr KC Class III Terminated California Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Missouri Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Austria Details
Biologics Mercy Medical Center Blood Bank Class III Terminated MA Details
Biologics Bio-Medics Class II Terminated Austria Details
Devices Beckman Coulter Inc. Class II Terminated Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Egypt, El Salvador, Ethiopia, France, Germany, Greece, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Lebanon, Libyan Arab Jamahiriya, Liechtenstein, Macao, Malaysia, Mexico, Netherlands, Nigeria, Pakistan, Panama, Philippines, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zambia. Details
Drugs Lloyd Inc. of Iowa Class II Ongoing Distribution was nationwide and to Puerto Rico. There was no foreign, military, or government distribution. Details
Devices GE Healthcare, LLC Class I Ongoing Worldwide Distribution - USA, including DC and the states of AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IN, IL, KY, KS, LA, MA, MD, ME, MI, MN, MO,MS, MT, NC, NE, NJ, NM, NY, NV, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Albania, Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, China, Czech Rep., Egypt, Finland, France, Germany, Great Britain, Greece, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, S. Korea, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and Arab Emirates, Details
Biologics LifeServe Blood Center Class II Terminated IA Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution--US (nationwide) including the states of AR, OH, OR, PA, TX VA & WI., and the countries of Algeria, Australia, Brazil, China, Ecuador, Finland, France, Germany, Hong Kong, India, Italy, Lebanon, Libyan Arab Jamahiriya, Russia, South Korea & United Kingdom Details
Devices Stryker Howmedica Osteonics Corp. Class II Ongoing Worldwide distribution: USA (nationwide) including states of: AL, CO, CT, IL, IN, MO, MS, NC, NJ, NY, OR,and TX; and countries of: Australia, Canada, France, Spain and United Kingdom. Details
Devices Brookstone Company, Inc. Class II Ongoing Nationwide Distribution. Details
Drugs Alara Pharmaceutical Co Class II Ongoing Nationwide Details
Devices Beckman Coulter Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) and the country of Canada. Details
Drugs F. Hoffmann-LaRoche Ltd. Class II Ongoing No product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea. Details
Food Spence & Co., Ltd. Class I Ongoing FL,NC, GA ,NJ, NY ,VA, OH, NV,OK,KY, TN, CO, IL, MA ,MO, RI,VT, NH ,ME, SC, IN, MI Details
Devices Greatbatch Medical Class II Ongoing Worldwide Distribution-USA including the states of AL, AK, AZ, ALR, CA, CO, CT, DC, FL, GA, HI, IL IN, IA, KY, MD, MA, MI, MN, MO, NE, NV,NM, NJ, NH, NY, NC, OH, OK OR, PA, RI,SC,SD, TN, TX, UT,VT, VA, WA, and WI, and the countries of AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HUNGARY, IRELAND, ISRAEL, ITALY, THE NETHERLAND, NORWAY, SWEDEN, AUSTRALIA, and CANADA Details
Devices Zimmer, Inc. Class I Ongoing Worldwide distribution: USA (nationwide) including states of: AR, AZ, CA, CO, CT, DC, FL, GA, ID, LA, MD, MI, MN, MO, NC, NV, NY, OH, OK, PA, TN, TX, WI, and WV; and countries of: Australia, El Salvador, France and Singapore. Details
Food Golub Corp Class I Completed Worcester, MA Details
Devices Praxair Inc. Class I Ongoing Worldwide distribution: USA (nationwide) and countries of: Brazil, Canada, China, Columbia, Costa Rica, India, Paraguay and Uruguay. Details
Devices sanofi-aventis US, Inc. Class II Ongoing Worldwide distribution. Details
Devices Roche Molecular Systems, Inc. Class II Ongoing Distributed in the states of GA, CA, NC, and MN. Details
Devices Arjo, Inc. dba ArjoHuntleigh Class II Ongoing USA (nationwide) including the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Dakota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming. Details
Food Taylor Farms Retail, Inc. Class I Ongoing CA and FL Details
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