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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics American National Red Cross (The) Class II Terminated PA, NY Details
Biologics Northwest Florida Blood Center, Inc. Class III Terminated Florida Details
Biologics Northwest Florida Blood Center, Inc. Class II Terminated Florida Details
Biologics Northwest Florida Blood Center, Inc. Class II Terminated Florida Details
Biologics Florida Georgia Blood Alliance, Inc. Class II Terminated FL Details
Biologics Children's Hospital of Orange County: Blood & Donor Services Class II Terminated CA Details
Biologics LifeSouth Community Blood Centers, Inc. Class III Terminated GA Details
Biologics Life Sera, Inc. Class II Terminated Germany Details
Biologics Northwest Florida Blood Center, Inc. Class II,Class III Terminated Florida, Switzerland Details
Biologics American National Red Cross Class III Terminated UT and CA Details
Biologics Community Blood Centers of South Florida, Inc. Class III Terminated FL Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated FL Details
Biologics American National Red Cross (The) Class II,Class III Terminated CA, OK, TX, UT, and NV Details
Biologics DCI Biologicals Orlando LLC Class II Terminated United Kingdom Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated MI, FL Details
Biologics Northwest Florida Blood Center, Inc. Class II Terminated FL Details
Biologics DCI Biologicals, Orlando LLC Class II Terminated United Kingdom Details
Biologics Community Blood Centers of South Florida, Inc. Class III Terminated FL Details
Biologics International BioResources, LLC Class II Terminated NC Details
Biologics International BioResources, LLC Class II Terminated NC Details
Biologics American National Red Cross (The) Class II Terminated UT, CA Details
Biologics Florida Blood Services, Inc. Class II Terminated FL Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated FL Details
Devices Alere San Diego, Inc. Class III Ongoing Nationwide distribution: USA including states of: AL, AK, AR, AZ, CA, CO, CT, DE, HI, IA, ID, IL, IN, FL, GA, KY, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, UT, TN, TX, VA, WA, WI, WV AND WY. Details
Biologics Suncoast Communities Blood Bank, Inc. Class III Terminated FL Details
Biologics LifeSouth Community Blood Centers Class II Terminated FL Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated FL Details
Drugs Aaron Industries Inc Class III Ongoing Nationwide in the US: MD, MI, AL, NC, CT, NY, PA, OR, WV. Details
Biologics Talecris Plasma Resources, Inc. Class III Terminated NC Details
Devices Technidata S.A. Class II Ongoing Worldwide Distribution-USA (nationwide) including Washington DC and the states of California, Nevada, Kentucky, Alabama, Rhode Island, Pennsylvania, and Louisiana and the country of Italy. Details
Devices DePuy Orthopaedics, Inc. Class II Completed Worldwide Distribution - USA Nationwide including the state of VA and the country of Ireland. Details
Food Whole Foods Market Class I Ongoing TX Details
Food Brookshire Grocery Company Manufacturing Class I Ongoing TX, Louisiana and Southern Arkansas Details
Veterinary Carolina Prime Pet Class I Ongoing AZ, CA, CO, DC, DE, HI, IL, MD, NE, NJ, NV, NM, PA, SD, TX, VA and WY. Details
Biologics Blood Bank of Alaska, Inc. Class II Terminated Alaska Details
Biologics Bergen Comm Reg Blood Center Class II Terminated NJ Details
Biologics Ogden Medical Center, Inc. Class II Terminated NV Details
Biologics LifeSource Class II Terminated IL Details
Biologics ONEBLOOD Inc DBA: Southeastern Comm. Blood Center Class III Terminated FL Details
Biologics Community Blood Center Of Gtr KC Class III Terminated KS Details
Biologics LifeServe Blood Center Class III Terminated FL Details
Biologics Virginia Blood Services Class II Terminated VA Details
Biologics Aurora Area Blood Bank Dba Heartland Blood Centers Class II Terminated IL Details
Biologics LifeServe Blood Center Class III Terminated IA Details
Biologics LifeServe Blood Center Class III Terminated IA Details
Biologics Inland Northwest Blood Center Class III Terminated WA Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated IA Details
Biologics Blood Center Hammond Laboratory (the) Class II Terminated LA Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated TN, FL Details
Biologics Bio-Blood Components, Inc. Class III Terminated TN Details
Biologics The American National Red Cross South Carolina Region Class III Terminated SC Details
Veterinary Nutri-Vet, LLC Class I Ongoing distributed nationwide and also to Hong Kong, Malaysia, Panama, and Singapore. Details
Veterinary United Pet Group Inc Class I Ongoing Product was shipped to the following states: AZ, CA, FL, GA, IL, IN, MI, MO, NC, NJ, NV, NY, OH, PA, SC, WA & WI. Product was also shipped to Canada. Details
Devices Molift Inc. Class II Ongoing US Nationwide Distribution: CA, FL, GA, ID, IL, KY, MA, ME, MI, MN, NC, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, VT, WA and Hawaii. Foreign Distribution:: Australia, Austria; Belgium, Denmark, Finland, France, Germany, Iceland, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Spain, Sverige, Switzerland, United Kingdom. Details
Devices Unimed Surgical Products, Inc. Class II Ongoing Distributed in the states of MO, TN, and PA. Details
Devices Linvatec Corp. dba ConMed Linvatec Class II Ongoing Worldwide Distribution-USA (nationwide) including the Virgin Islands and the states of CA, CT, FL, GA, IN, KY, KS, LA, MD, MI, MN, MO, MS, MT, NE, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, and WI, and the countries of Austria, Belgium, Canada, Denmark, Hong Kong and Zambia. Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, 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, PR, RI, SC, TN, TX, VA, VT, WA, WI, WV and WY; countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Denmark, France, Germany, Gibraltar, India, Iraq, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Philippines, Poland, Portugal, Singapore, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Venezuela. Details
Devices Separation Technology, Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of PA, NC, IL, KS, and FL, and the countries Canada and Turkey. Details
Veterinary Abbott Animal Health Class III Ongoing Nationwide (CA, GA, IA, IN, KY, MN, OR, TX, VA, WA) Details
Devices Roche Diagnostics Operations, Inc. Class II Ongoing USA Nationwide Distribution Details
Devices Ortho-Clinical Diagnostics Class III Ongoing Worldwide Distribution - Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela. Details
Veterinary Bimeda MTC Animal Health Inc. Class II Ongoing Nationwide (KS and WI) Details
Food Clement Pappas & Co., Inc. Class II Ongoing Nationwide Details
Food Win Luck Trading Inc Class I Ongoing New York Details
Devices Roche Molecular Systems, Inc. Class II Ongoing Nationwide Distribution. Details
Devices Progressive Medical Inc Class II Ongoing Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI. Details
Devices Stryker Howmedica Osteonics Corp. Class II Ongoing Nationwide distribution: USA including states of: HI, IN, MS, NC, NJ, OK, TX, and WI. Details
Devices Coloplast Manufacturing US, LLC Class II Ongoing Nationwide Distribution including AL, CA, CO, DC, IL, IN, KY, MD, MA, MO, NH, OH, RI, and VA. Details
Food Go Max Go Foods Class I Ongoing Nationwide distribution to 14 distributors and 26 retailers. Products were distributed to Canada, UK, Germany, and Australia. No government or VA consignees. Details
Food Alfred Louie Inc Class I,Class II Ongoing CA, ID, AZ, NV. Details
Devices Chicago X-Ray Systems, Inc. Class II Ongoing Worldwide Distribution- USA (nationwide) and Latin America. Details
Veterinary Nora Apothecary and Alternative Therapies, Inc. Class III Ongoing IN, OH, IL, FL, TN Details
Drugs Novartis Consumer Health Class III Ongoing Nationwide Details
Food Conagra Inc Class I Ongoing Distribution was made nationwide. Details
Devices CEFLA DENTAL GROUP Class II Ongoing US Nationwide Distribution Details
Food Krinos Foods, Inc. Class I Ongoing CA, CO, CT, FL, GA, IA, IL, IN, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, RI, SC, TX, VA, VI and WI Details
Devices Boston Scientific CRM Corp Class II Ongoing Nationwide Distribution including DC and PR Details
Drugs Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Class III Ongoing Nationwide Details
Drugs Lloyd Inc. of Iowa Class II Ongoing The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico. Details
Devices Medical Information Technology, Inc. Class II Ongoing Worldwide Distribution - USA, including Puerto Rico and the country of Canada. Details
Drugs King Legacy, a wholly owned subsidiary of Pfizer Class II Ongoing Nationwide and Puerto Rico Details
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