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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics South Florida Blood Banks, Inc. Class II Terminated Florida Details
Biologics American National Red Cross (The) Class II Terminated Arizona Details
Biologics American National Red Cross (The) Class II Terminated AZ Details
Biologics American National Red Cross (The) Class II,Class III Terminated CA, AZ Details
Biologics Csl Plasma Inc Class II Terminated Switzerland, Germany, IL, MA, CA Details
Devices GE Healthcare It Class II Ongoing USA Nationwide Distribution in the state of OK Details
Devices Sysmex America Inc Class II Ongoing Worldwide distribution: US (Nationwide) including Puerto Rico and states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and country of Canada. Details
Devices Integra LifeSciences Corp. Class II Ongoing Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA. Details
Biologics New York Blood Center, Inc. Class II Terminated New York Details
Biologics OneBlood / dba CBCF Class II,Class III Terminated Switzerland; Florida Details
Biologics Biomat USA, Inc. Class II Terminated Spain Details
Biologics Mississippi Valley Reg Bld Ctr Class III Terminated Illinois Details
Devices Siemens Medical Solutions USA, Inc. Class II Ongoing Worldwide Distribution - US (nationwide) including the states of IL, PA, AZ, OR, OH, NY, CO, TX and CA., and the countries of France, Germany, Japan, Portugal, Saudi Arabia, Taiwan and Turkey. Details
Biologics Blood Assurance Inc Class II,Class III Terminated Tennessee; New York Details
Biologics Community Blood Center of Carolinas Class II Terminated North Carolina Details
Biologics Innovative Blood Resources Class III Terminated Wisconsin Details
Biologics Mississippi Blood Services Inc. Class II,Class III Terminated Mississippi; Switzerland Details
Biologics Upstate New York Transplant Services Class II Terminated New York Details
Biologics American National Red Cross Class III Terminated California Details
Biologics OneBlood, Inc. Class II Terminated Florida Details
Devices DePuy Spine, Inc. Class II Ongoing Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY. Details
Food Evershing International Trading Inc. Class II Ongoing CA, WA, OR Details
Biologics OneBlood / dba CBCF Class II,Class III Terminated Switzerland; Florida Details
Biologics Plasma Biological Services, Inc Class II Terminated California Details
Biologics OneBlood, Inc. Class II,Class III Terminated Florida Details
Biologics Aurora Area Blood Bank Dba Heartland Blood Centers Class III Terminated Illinois Details
Biologics Interstate Blood Bank, Inc of Wisconsin Class II Terminated California Details
Biologics OneBlood, Inc. Class II,Class III Terminated Switzerland; Florida Details
Biologics OneBlood, Inc. Class II Terminated Florida; New York Details
Biologics BioLife Plasma Services, L.P. Class II Terminated California Details
Devices Aesculap, Inc. Class II Ongoing Nationwide Distribution. Details
Biologics Mid-South Regional Blood Center Class II Terminated Tennessee Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated Michigan Details
Devices Synergetics Inc Class II Ongoing Nationwide Distribution-USA including the states of MO, CO, KY, TN, NC, PA, IL CA, NY, IN, MI, LA, NJ and OH. Details
Biologics Indiana Blood Center Class II Terminated Indiana Details
Biologics Virginia Blood Services Class III Terminated Pennsylvania; Virginia Details
Devices OPTI Medical Systems, Inc Class II Ongoing Worldwide distribution: US (nationwide) including states of: CA, MA, MN, and VA; and countries of: China, Guatemala, India, Iraq, South Korea, and Untied Arab Emirates. Details
Devices Varian Medical Systems, Inc. Class II Ongoing Worldwide distribution: US (nationwide) distribution in CA and in the country of India. Details
Food Chobani Idaho Class II Ongoing distributed nationwide Details
Biologics American National Red Cross The Class II Terminated California Details
Biologics Tacoma Pierce County Blood Bank Class III Terminated Washington; New Jersey; New York Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Kansa, Missouri Details
Biologics Arc Blood Services, New England Region Class II Terminated New Hampshire; New York Details
Biologics DCI Biologicals LLC Class II Terminated United Kingdom Details
Biologics DCI Biologicals Orlando LLC Class II Terminated Pennsylvania Details
Drugs Hi-Tech Pharmacal Co., Inc. Class III Ongoing Puerto Rico Details
Food Vinco Inc. Class II Ongoing Nationwide. Details
Food The Dannon Company, Inc. Class II Ongoing Nationwide. Details
Devices DePuy Orthopaedics, Inc. Class II Ongoing Distributed in Puerto Rico and US Virgin Islands. Details
Food Garre Farms Class I Completed Distributed in California, Oregon, Washington Details
Devices Bio-Rad Laboratories Class III Ongoing US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA Details
Devices Abbott Medical Optics, Inc. Class II Ongoing Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America. Details
Devices Perkin Elmer Health Sciences, Inc. Class II Ongoing US distribution in OH Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution - US (nationwide) including FL, CO, KY, MS, PA, NC, NJ, TX and Puerto Rico and internationally to Italy. Details
Devices Advanced Sterilization Products Class II Ongoing Nationwide Distribution Details
Food Dean Foods, Inc. Class III Ongoing Products sold to various accounts in Southern California and Arizona only. Details
Devices Becton Dickinson & Co. Class II Terminated USA Nationwide Disatribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, IL, KY, MA, ME, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TX, UT, VA, WA, WI Details
Devices Advanced Sterilization Products Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of EA (Europe Middle East and Asia), APAC (Asia Pacific), Japan and Canada Details
Devices GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally to China, India, Japan, Malaysia, Australia, Ireland, France, Germany, Spain, Hungary, Belgium, and Switzerland. Details
Food NatureMost of New England, Inc. Class I Ongoing Strawberry Banana: GA.,MA.,CT.,AR.,NY.,NJ.,MD.,NH.,TX., CA., FL; Vanilla Almond: GA, NC.,MA.,CT.,AR.,NY.,RI.,NJ.,MN.,SC.,AZ.,OH.,MD.,IN.,NH.,TX. St. Thoms, USVI Details
Devices Convergent Dental Class II Ongoing US distribution including states of: MA, CT, NY. Details
Food Norpac Foods, Inc. Class I Ongoing Products distributed in Illinois, Missouri, and Nebraska. Details
Devices Alere San Diego, Inc. Class III Ongoing Worldwide Distribution - USA (nationwide) and countries of: South Africa and Canada Details
Devices Merit Medical Systems, Inc. Class II Ongoing US Distribution including the states of CO, VA, and MS. Details
Drugs Tolmar, Inc. Class III Ongoing Nationwide Details
Devices AGFA Corp. Class II Terminated Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada. Details
Drugs Nephron Pharmaceuticals Corp. Class II Ongoing Nationwide and Puerto Rico Details
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