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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Blood Systems, Inc. Class II Terminated Arizona Details
Biologics Blood Systems, Inc. Class II Terminated Arizona Details
Biologics Blood Systems, Inc. Class II Terminated Arizona Details
Biologics Blood Systems, Inc. Class II Terminated Arizona Details
Biologics Blood Systems, Inc. Class II Terminated Arizona Details
Biologics Biomat USA, Inc. Class III Terminated Spain Details
Biologics Biomat USA, Inc. Class III Terminated CA, Spain Details
Biologics HemaCare Corporation Class II Terminated California Details
Biologics American National Red Cross (The) Class II Terminated Arizona Details
Biologics CSL Plasma Inc Class II Terminated North Carolina Details
Biologics Tri-counties Blood Bank Class II Terminated California Details
Biologics Tri-counties Blood Bank Class III Terminated California Details
Biologics Tri-counties Blood Bank Class III Terminated California Details
Biologics Tri-counties Blood Bank Class III Terminated CA Details
Biologics Tri-counties Blood Bank Class III Terminated California Details
Biologics Community Blood Centers of South Florida, Inc. Class III Terminated Florida Details
Biologics PlasmaCare Inc Class II Terminated OH Details
Biologics Blood Bank Of San Bernardino and Riverside Counties Class III Terminated California Details
Biologics Hoxworth Blood Center University of Cincinnati Medical Center Class II Terminated OH Details
Biologics Southern California Permanente Medical Group Blood Donor Center Class II Terminated CA Details
Biologics Blood Bank of San Bernardino and Riverside Counties Class III Terminated California Details
Drugs Fresenius Kabi USA LLC (FK USA) Class II Ongoing Nationwide Details
Food NuGo Nutrition HQ Class I Ongoing Nationwide and Canada. Details
Biologics Department of Air Force - BB/HT Class II Terminated TX Details
Biologics Medic Inc Class III Terminated Switzerland Details
Biologics LifeServe Blood Center Class II Terminated SD Details
Biologics OneBlood / dba CBCF Class II Terminated FL Details
Biologics Inland Northwest Blood Center Class II,Class III Terminated Switzerland; WA; CA Details
Biologics Blood Systems, Inc. Class II Terminated NV Details
Biologics Department of Army US Army Blood Bank Center Class II Terminated Afghanistan Details
Food Galveston Shrimp Company, Inc. Class II Ongoing All product was distributed in Texas. Details
Biologics Community Blood Centers of Florida, Inc. Class II Terminated Florida; New York Details
Biologics American National Red Cross Class III Terminated California Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Michigan; Florida Details
Biologics HCSC-Blood Center Class II,Class III Terminated Pennsylvania Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida Details
Biologics BloodSource, Inc. Class II Terminated Austria; New York Details
Biologics Community Blood Centers of South Florida, Inc. Class II,Class III Terminated Tennessee; Florida Details
Biologics Community Blood Centers of South Florida, Inc. Class II,Class III Terminated Switzerland; Florida Details
Biologics Blood Systems Inc Class III Terminated IL, AZ Details
Biologics DCI Biologicals Temple Terrace, LLC Class II Terminated CA Details
Biologics Community Blood Center of Carolinas Class II Terminated NC Details
Biologics Plasma Biological Services Class II Terminated TN Details
Biologics Community Blood Centers of South Florida, Inc. Class II,Class III Terminated Switzerland, FL, NY Details
Biologics Community Blood Centers of South Florida, Inc. Class II,Class III Terminated Tennessee; Switzerland; Florida; California Details
Biologics Northern California Community Blood Bank Class II Terminated CA Details
Devices Zimmer, Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) and the country of Japan. Details
Biologics LifeNet Health Class II Terminated Massachusetts Details
Biologics Life Technologies Holdings Pte Ltd Class III Ongoing DE,. IL, MA, MN,NE, OR. Details
Devices Invacare Corporation Class II Ongoing Nationwide distribution: USA including states of: CA, FL, IN, MN, NJ, NY, OH, RI, SC, SD, TX, and VA. Details
Drugs Medicis Pharmaceutical Corp Class II Ongoing Nationwide, Great Britain, Mexico, Russia and The Ukraine. Details
Drugs Earthlabs, Inc. DBA Wise Woman Herbals Class II Ongoing Nationwide Details
Food Harmony Chai Class II Ongoing Retail stores, one farmers' market in Washington State, and two internet customers in Washington State Details
Devices Medtronic MiniMed Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of Australia, Bermuda, Brazil, Canada, Chile, Columbia, Ecuador, El Salvador, Germany, Japan, Mexico, Netherland, Paraguay, Puerto Rico, Singapore, Uruguay and Venezuela. Details
Food Whole Foods Market Class I Ongoing Retail Stores Nationwide Details
Drugs Stayma Consulting Service, LLC. Class III Ongoing Nationwide. Details
Drugs Braintree Laboratories Inc. Class III Ongoing Nationwie Details
Devices Atrium Medical Corporation Class II Ongoing Nationwide Distribution. Details
Food Pacific Pure Aid Class II Terminated CA, NJ, KY, OH, and IL Foreign - France, Ireland, Australia, England, and Hungry Details
Devices Smith & Nephew Inc Class II Ongoing International only: Germany, France, United Arab Emirates, and United Kingdom. Details
Food Zip International Group LLC. Class II Ongoing IN, ND & NY Details
Devices Aspen Surgical Products, Inc. Class II Ongoing Worldwide Distribution - US Nationwide in the state of Florida and in the countries of , Netherlands, and Reditch Worcestershire England Details
Drugs VistaPharm, Inc. Class II Ongoing Nationwide. Details
Food Plum Inc Class II Ongoing Nationwide and Bermuda. Details
Devices Stryker Spine Class I Ongoing Nationwide Distribution. Details
Devices Gyrus Medical, Inc Class II Ongoing Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, FL, GA, IL, IN, KS,KY, MD, MA, MI, MN, MS, MO, NY, NC, OH, PA, SD, TN, TX, VA and WI., and the countries of BRAZIL, CHINA, AUSTRALIA, CHINA, GERMANY and INDIA. Details
Devices GE Healthcare, LLC Class II Ongoing US Distribution in the state of CT. Details
Devices Boston Scientific CRM Corp Class II Ongoing US distribution in the state of Tennessee. Details
Food Green Core Class III Terminated VA, TN, GA, NC, SC, FL Details
Food Johnson Brothers Liquor Company, Inc Class II Ongoing AL, AZ, GA, IN,KY, MI, MO , NE, NV, NC, OH, SC. Details
Devices Beckman Coulter Inc. Class II Ongoing Worldwide Distribution - USA and the country of Canada. Details
Devices Zimmer, Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of CT, FL, GA, IL, IN, KS, KY, MA, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VI, and WI, and the countries of Singapore, Canada, Mexico, Arab Emirates, Saudi Arabia, and Hong Kong. Details
Devices Blue Belt Technologies MN Class II Ongoing Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom. Details
Devices Philips Healthcare Inc. Class II Ongoing US Nationwide Distribution including Puerto Rico Details
Drugs Novartis Consumer Health Class III Ongoing Nationwide, Canada, and Panama. Details
Food SensoryEffects Powder Systems Class II Ongoing Product was shipped to the following states: KY, MN, SD, WA. Product was also shipped to Canada. Details
Drugs AbbVie Inc. Class III Ongoing Nationwide Details
Devices Endogastric Solutions Inc Class II Ongoing Distributed nationwide and Italy. Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution - USA Nationwide in the states of AL, AK, AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, MD, MA, NMI, MN, MS, MO, NE, NV,NH,NJ, NM, NY, NC,ND, OH, OK OR, PA,SC, SD, TN, TX, UT, VA, WA, WV, WI, WY and the countries of CANADA, FRANCE GERMANY, GREAT BRITAIN ITALY, PANAMA, SAUDI ARABIA. Details
Devices Getinge USA Inc Class II Ongoing Worldwide Distribution - USA and the country of Canada. Details
Devices Sorin Group USA, Inc. Class II Ongoing Nationwide Distribution Details
Devices Convatec Inc. Class III Ongoing US Nationwide Distribution Details
Devices Stryker Communications Class II Ongoing Worldwide Distributio: US natiowide and to the country of Canada. Details
Devices Medicel Ag Class II Ongoing Nationwide Distribution. Details
Food Mariposa Baking Co. Class II Ongoing one distributor in CA. Number of retail locations forthcoming. Details
Drugs Bracco Diagnostics Inc Class III Ongoing Nationwide Details
Food S & M International Inc Class III Ongoing NY Details
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