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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Florida Blood Services, Inc. Class II Terminated Florida Details
Biologics American National Red Cross (The) Class III Terminated California Details
Biologics Talecris Plasma Resources Inc Dba International Bioresources Class III Terminated North Carolina Details
Biologics Talecris Plasma Resources Inc Dba International Bioresources Class II Terminated North Carolina Details
Biologics Talecris Plasma Resources Inc Dba International Bioresources Class III Terminated North Carolina Details
Biologics Talecris Plasma Resources Inc Dba International Bioresources Class III Terminated North Carolina Details
Biologics Csl Plasma Inc Class II Terminated IL, Switzerland Details
Biologics Talecris Plasma Resources Inc Dba International Bioresources Class III Terminated North Carolina Details
Biologics Talecris Plasma Resources Inc Dba International Bioresources Class III Terminated North Carolina Details
Biologics Csl Plasma Inc Class II Terminated Illinois, Switzerland, Germany Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated North Carolina Details
Biologics Talecris Plasma Resources Inc Dba International Bioresources Class III Terminated North Carolina Details
Biologics Community Blood Center Of Gtr KC Class II Terminated MO; KS; LA; CA; Details
Biologics American National Red Cross (The) Class II Terminated PA, NY Details
Biologics Biotest Pharmaceuticals Corporation Class II Terminated PA Details
Biologics Octapharma Plasma, Inc. Class III Terminated Austria Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide Distribution-USA (nationwide) including DC and Puerto Rico 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, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand. Details
Devices St. Jude Medical Class II Ongoing Worldwide Distribution - USA Nationwide Including Puerto Rico and countries of: Argentina, Australia, Belgium, Brazil, Canada, China, Chile, Colombia, Ireland, Israel, India, Malaysia, Mexico, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland and United Kingdom. Details
Food MR Cuts, L.p. Class I Ongoing TX Details
Drugs Apotex Corp. Class I Ongoing Nationwide Details
Biologics Marquette General Hospital, Inc, UP Reg Bl Ctr Marquette Class II Terminated Michigan Details
Biologics CSL Plasma, Inc. Class II Terminated Germany Details
Biologics Central California Blood Center Class II Terminated Switzerland; California Details
Biologics South Texas Blood & Tissue Center Class II,Class III Terminated Texas Details
Biologics Blood Centers of the Pacific - Irwin Center Class III Terminated California Details
Biologics Blood Systems Inc Class II Terminated Arizona Details
Biologics Blood Centers of the Pacific - Irwin Center Class II Terminated California Details
Devices SpineFrontier, Inc. Class II Completed USA Nationwide Distribution including the state of TX Details
Biologics Community Blood Centers of South Florida, Inc. Class II,Class III Terminated Florida Details
Biologics American National Red Cross (The) Class II Terminated California Details
Biologics Talecris Plasma Resources Inc Class III Terminated North Carolina Details
Biologics Memorial Blood Centers Class II Terminated Minnesota Details
Biologics Central Blood Bank Class II Terminated Pennsylvania Details
Biologics Central Blood Bank Class II Terminated Pennsylvania Details
Devices Paa Laboratories Inc Class II Ongoing Worldwide Distribution - USA (nationwide), and countries of: Canada and Novia Scotia. Details
Biologics Community Blood Centers of South Florida, Inc. Class III Terminated Switzerland Details
Biologics American National Red Cross (the) Class II Terminated Massachusetts Details
Biologics Hoxworth Blood Center UC Medical Center Class II Terminated Ohio Details
Biologics Lifesouth Community Blood Centers - Montgomery Region Class II Terminated Alabama Details
Biologics LifeServe Blood Center Class II Terminated Switzerland Details
Biologics Oklahoma Blood Institute - Sylvan N Goldman Center Class II Terminated Oklahoma Details
Devices Roche Diagnostics Operations, Inc. Class II Ongoing Nationwide distribution: USA including states of: AL, CA, GA, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, TX, VA, VT, and WA. Details
Devices Leibel-Flarsheim Company LLC Class II Ongoing Nationwide Distribution (US), including the states of TN, KY, CO, KS, CT, HI, and AZ. Details
Devices Baxa Corporation Class II Ongoing Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan. Details
Biologics CryoLife, Inc. Class III Terminated Pennsylvania; Nebraska; Indiana Details
Biologics CryoLife, Inc. Class III Terminated New York Details
Biologics CryoLife, Inc. Class III Terminated New York; West Virginia; Indiana Details
Biologics CryoLife, Inc. Class III Terminated California; Texas Details
Biologics CryoLife, Inc. Class III Terminated Canada; South Carolina; Florida Details
Biologics CryoLife, Inc. Class III Terminated Michigan; Maryland; Texas; Minnesota Details
Biologics CryoLife, Inc. Class III Terminated California; Texas Details
Biologics CryoLife, Inc. Class III Terminated Louisiana; Georgia Details
Biologics CryoLife, Inc. Class III Terminated Canada; New York Details
Devices Boston Scientific Corporation Class II Ongoing Worldwide distribution: US (nationwide) including states of: CA, FL, IA, ID, MI, OK, TA and WA; and countries of: Canada and Thailand. Details
Veterinary RI Textile Company Class II Ongoing Nationwide Details
Devices Zeiss, Carl Inc Class II Ongoing Distributed in the states of MI, TX, SD, FL, GA, NY, and NY. Details
Devices Integra LifeSciences Corporation Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Israel, Italy, Netherlands, Portugal, Russia, Saudia Arabia, South Africa, Spain and United Arab Emirates. Details
Devices Codman & Shurtleff, Inc. Class I Ongoing Worldwide Distribution-USA (nationwide) including the states of FL, NC, NJ, and TX, and the countries of Austria, Australia, Belgium, China, Denmark, Spain, Great Britain, Germany, Italy, Ireland, Luxemburg, Russia, Saudi Arabia, and Turkey. Details
Food Kenton Burr Class III Ongoing New York State (Fingerlakes region) Details
Devices Stryker Instruments Div. of Stryker Corporation Class II Ongoing Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan. Details
Food Nassau Candy Class I Ongoing NY, NJ, CT, ME, PA, MD, NC, IN, TX, IL, FL, UT, CO Details
Devices Edwards Lifesciences, LLC Class II Ongoing Worldwide Distribution - USA (nationwide) and Canada. Details
Devices Karl Storz Endoscopy America Inc Class II Terminated US distribution to: AZ, FL, IL, IN and TX. Details
Drugs Sandoz Incorporated Class II Ongoing Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees. Details
Drugs Fresenius Kabi USA, LLC Class II Ongoing Nationwide and Puerto Rico Details
Drugs Teva Pharmaceuticals USA, Inc. Class III Ongoing Nationwide Details
Food Windy Acres Candy & Nut, Outlet Inc. Class I Ongoing The product was distributed only to two consignees in the state of Ohio. Details
Devices Staar Surgical Co. Class II Ongoing Nationwide distribution: USA including states of: AL,AZ, CA, CO, CT, FL, GA, HI, KY, IA, IL, IN, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV. Details
Devices Synthes USA HQ, Inc. Class II Ongoing US Nationwide Distribution including the states of MA, TX, MN, SC, UT, VA, and NY. Details
Food Kroger Co Class I Ongoing The affected product was only distributed in the states of WA and OR. Details
Food Fresh Unlimited Inc Class I Ongoing The affected product was distributed to the following states: Indiana, Kentucky, Michigan, New York, Ohio, and Pennsylvania. Details
Food Sani Fresh Distribution Class I Ongoing Borough of Queens, NY Details
Food Talenti Gelato Class II Ongoing Alaska, CT, ID, IL, IN, MD, MA, MT, NH, NJ, NY, NC, OH, PA, TN, VA, WA and WI. Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing United States Nationwide Distribution - including the states of: CA, CO, FL, IA, IL, IN, MA, MD, MI, NC, NY, PA, TX, VA and WA and Puerto Rico. Details
Food Somersault Snack Co., LLC Class I Ongoing Distribution centers in CA, OH, GA, KS and SC and then on to stores in AZ, FL, HI, MO, NC,NE, NV, NY, OK, PA, TX and WV. Details
Drugs Church & Dwight Inc Class II Ongoing Nationwide Details
Devices Hospira Inc. Class II Ongoing Worldwide Distribution - US (nationwide) including the states of IA, IL, MN, SD and WA., and Costa Rica. Details
Devices Technidata S.A. Class III Ongoing US Distribution CA only. Details
Devices KooJoo Trading Company Class II Ongoing US Distribution GA only. Details
Devices Synthes USA HQ, Inc. Class II Ongoing Nationwide Distribution including PA, CT, DE, and NY. Details
Drugs American Health Packaging Class II Completed Nationwide Details
Drugs Bayer HealthCare Pharmaceuticals Inc. Class III Ongoing NY, CA Details
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