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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Tri-Counties Blood Bank dba UBS- Central Coast Class II Terminated CA Details
Biologics American National Red Cross (The) Class II,Class III Terminated Ohio, Switzerland Details
Biologics Biomat USA, Inc. Class III Terminated Spain Details
Biologics Presbyterian Intercommunity Hospital, Inc. Blood Bank Class III Terminated CA Details
Biologics Presbyterian Intercommunity Hospital, Inc. Blood Bank Class III Terminated California Details
Biologics Presbyterian Intercommunity Hospital, Inc. Blood Bank Class III Terminated California Details
Biologics Presbyterian Intercommunity Hospital, Inc. Blood Bank Class III Terminated California Details
Biologics Presbyterian Intercommunity Hospital, Inc. Blood Bank Class III Terminated California Details
Biologics Southern California Permanente Medical Group Blood Donor Center Class II Terminated CA Details
Biologics Southern California Permanente Medical Group Blood Donor Center Class III Terminated CA Details
Biologics Department of the Navy Class III Terminated New Jersey Details
Biologics San Diego Blood Bank Class III Terminated California Details
Biologics Csl Plasma Class II Terminated IL, Germany Details
Biologics CSL Plasma, Inc. Class II Terminated Illinois, Germany Details
Biologics Octapharma Plasma, Inc. Class III Terminated Austria Details
Biologics Csl Plasma Inc Class II Terminated Illinois, Germany, Switzerland. Details
Food The Warrell Corporation Class I Ongoing Product was distributed to retailers in DE, FL, GA, MD, MO, NH, NJ, NY, PA, VA, and WV. Details
Biologics University Of Miami Miller School of Medicine Tissue Bank Class III Terminated Florida and Texas Details
Devices DePuy Spine, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) including AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV and WY; and internationally to: Algeria, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Latvia, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UAE and UK. Details
Biologics OneBlood / dba CBCF Class II Terminated Florida Details
Food Saratoga Therapeutics, LLC Class I Ongoing Product was sold through physicians offices and via internet sales to consumers located nationwide and in Canada. Details
Drugs Beamonstar Products Class I Ongoing US states nationwide and international. Details
Biologics Community Blood Center of the Ozarks Class II Completed Switzerland; North Carolina; Austria; Missouri; Arkansas Details
Biologics Community Blood Centers of Florida, Inc. Class II Terminated FL Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida Details
Biologics Community Blood Centers of South Florida, Inc. Class II,Class III Terminated Florida Details
Biologics Florida's Blood Centers - Lake Park Class II Terminated FL Details
Food Contoocook Creamery Class II Ongoing NH only. No foreign distribution. Details
Biologics Carter BloodCare Class II,Class III Terminated Switzerland, TX Details
Biologics Data Innovations, Inc. Class II Completed Nationwide. Details
Biologics Data Innovations, Inc. Class II Completed Nationwide; Canada Details
Biologics OneBlood / dba CBCF Class II,Class III Terminated Florida Details
Biologics OneBlood, Inc. Class II Terminated Florida Details
Biologics Sanofi Pasteur, Inc. Class III Terminated Multiple U.S. States Details
Biologics OneBlood, Inc. Class II,Class III Terminated Switzerland; Florida Details
Biologics LifeShare Blood Centers Class II Terminated Louisiana; Texas Details
Devices Genzyme Corporation, A Sanofi Company Class II Ongoing Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK. Details
Food Terrafina Class I Ongoing NY, NJ, FL Details
Biologics Eye Bank Of Wisconsin, Inc. Class III Terminated Wisconsin; West Virginia Details
Biologics International Sight Restoration, Inc. Class II,Class III Terminated Egypt; Lebanon; Argentina; Mexico; Romania; South Africa; Iraq Details
Biologics International Sight Restoration, Inc. Class III Terminated Egypt; Florida Details
Biologics Immucor Inc Class III Terminated Nationwide; Worldwide Details
Biologics OneBlood / dba CBCF Class II,Class III Terminated Illinois; Florida; New York Details
Biologics American National Red Cross, Penn-Jersey Region Class II Terminated Pennsylvania; New Jersey Details
Biologics Blood Systems, Inc. dba United Blood Services Texas Class II Terminated Switzerland Details
Biologics Merck Sharpe & Dohme Corp Class III Terminated Multiple U.S. States Details
Biologics University Of Miami Miller School of Medicine Tissue Bank Class II Terminated Mississippi; Puerto Rico; Maryland; Florida; Guatemala; New York Details
Food Tortilleria Lupita, Inc. Class II Ongoing OK Details
Devices Stelkast Co Class II Ongoing Nationwide Distribution including TX, VA, OK, and PA Details
Devices Siemens Healthcare Diagnostics Class II Ongoing Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Argentina, Austria, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hungary, Indonesia, Italy, Kazakhstan, Lithuania, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, South Africa, South Korea, Thailand, Turkey, Uruguay, Vatican City, and Vietnam. Details
Food La Terra Fina USA, Inc. Class III Terminated CA, CO, TX, IN.. Details
Food Zip International Group LLC. Class I Ongoing NY Details
Devices Boston Scientific Corporation Class II Ongoing Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV,NH,NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC,SC, TN, TX, UT, VA, WA, WV, and WI. Internationally to Algeria, Finland, Japan, Spain, Australia, France, Latvia, Sweden, Austria, Germany, Netherlands, Switzerland, Belgium, Great Britain, Norway, Taiwan, Brazil, Greece, Panama, Turkey, Canada, Hong Kong, Poland, Unit.Arab Emir., China, India, Russian Fed., Colombia, Ireland, Saudi Arabia, Czech Republic, Israel, South Africa, Denmark, Italy, and South Korea. Details
Devices Copan Italia Class III Ongoing Worldwide Distribution - USA (nationwide) including Oregon and California, and internationally to: France, Belgium, Italy, Denmark, Norway, Switzerland, Romania, Finland, Germany, South Africa, Canada, Ireland, UK, Sweden and Japan. Details
Food Dove Chocolate Discoveries Llc Class I Ongoing Nationwide Details
Drugs Teva Pharmaceuticals USA, Inc. Class II Ongoing Nationwide Details
Food Thrive Foods LLC Class III Ongoing The product was distributed nationwide, in all U.S. states, and in Canada (Wade & Sandy Pierson Company Name: In Case Of , #102 127 Commercial Drive , Calgary AB T3Z 2A7 Canada, Tel. 403-381-0005). The product was not distributed to the U.S. Defense Supply Center, VA or other Federal Government Agency Sales/distribution center. Details
Food Justin'S Nut Butter Class III Ongoing Nationwide. No foreign, military, gov't, VA distribution. Details
Food Potters Fine Foods, LLC Class III Ongoing IL, NY, NC, WI. Details
Devices MicroAire Surgical Instruments, LLC Class II Ongoing Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom. Details
Food Greenland Trading Corp Class III Ongoing CT, FL, MA, NJ & NY Details
Veterinary Wedgewood Village Pharmacy, Inc. Class II Ongoing Nationwide Details
Devices Elekta, Inc. Class II Ongoing Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico. Details
Food Conagra Inc Class I Ongoing Distribution was made to: Alabama, Alaska, Arizona, California, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Michigan, Missouri, Montana, Nebraska, Nevada, New Mexico, North Carolina, Ohio, Oregon, South Carolina, Tennessee, Utah, Virginia, Washington, West Virginia and Wyoming. Details
Food Crown Pacific Int'L Llc Class III Ongoing One distributor in both CO and VA Details
Food The Seafood Exchange Of Fla Class II Ongoing TX Details
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