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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated PA, IL, Switzerland Details
Biologics LifeServe Blood Center Class II Terminated IA, MO, FL, VA, Austria Details
Biologics ZLB Bioplasma, Inc. Class II Terminated NC, Switzerland Details
Biologics LifeServe Blood Center Class II Terminated FL, IA Details
Biologics American Red Cross Blood Services Class II Terminated Missouri Details
Biologics American Red Cross Blood Services Class II Terminated Georgia Details
Biologics Siouxland Community Blood Bank Class III Terminated SD Details
Biologics American National Red Cross Class II Terminated California. Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated IL, PA, IA, MS, MO Details
Biologics International BioResources, LLC Class III Terminated NC Details
Biologics LifeServe Blood Center Class III Terminated IA Details
Biologics LifeServe Blood Center Class II Terminated IA Details
Biologics American Red Cross Blood Services Class II,Class III Terminated OK, TX Details
Biologics American National Red Cross (The) Class II,Class III Terminated IL and MO Details
Biologics American Red Cross Blood Services Class II,Class III Terminated TX and MO Details
Biologics American Red Cross Blood Services Class II Terminated Arkansas Details
Biologics American National Red Cross (The) Class II,Class III Terminated CA, MA, NH, VT Details
Biologics Biomat USA, Inc. Class II Terminated California, Spain, and Japan. Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated NC Details
Biologics Talecris Plasma Resources, Inc. Class III Terminated NC Details
Biologics American National Red Cross (The) Class III Terminated AR Details
Biologics New York Blood Center, Inc. Class II,Class III Terminated NY, NJ, PA, CA, NC Details
Biologics DCI Biologicals LLC Class II Terminated CA Details
Biologics American National Red Cross (The) Class III Terminated CT, NY Details
Devices Hill-Rom, Inc. Class II Ongoing Worldwide Distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, 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, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and CANADA LOCATIONS: AB, BC, MB, NB, NS, ON, and SK. Details
Devices Stryker Sustainability Solutions Class II Ongoing Distributed in Arizona and New Jersey. Details
Devices DePuy Orthopaedics, Inc. Class I Ongoing Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, GA, ID, IL, MA, MD, MI, MN, NC, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV and the countries of Holland, Australia, Austria, South Africa and Canada including Veteran Administration hospitals. Details
Drugs Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Class I Ongoing Nationwide Details
Devices Healthtronics, Inc. Class II Ongoing CA, CO, FL, GA, NC, NJ, OH, TX, and WI. No international distribution. Details
Drugs P & J Trading Co Class I Ongoing Nationwide and Korea Details
Devices International Technidyne Corp. Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally to Bermuda, Canada, Chile, Denmark, Germany,Italy,Latvia, Lithuania, Malaysia, Phillipines, South Africa, Spain, Switzerland, Taiwan, and United Arab Emirates. Details
Drugs Procter & Gamble Hair Care Llc Class III Ongoing Nationwide Details
Devices Codman & Shurtleff, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland. Details
Devices Integra LifeSciences Corp. Class II Ongoing Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA & WI. Internationally to Belgium. Details
Food Bimbo Bakeries Usa Class II Ongoing Products were to distributed to grocery outlets within the US in AL, FL, GA, LA, MS, NC, SC, and TN. Details
Biologics Hemacare Corporation Class III Terminated California Details
Devices Philips Healthcare Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally to ALGERIA, ANGOLA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BULGARIA, COLOMBIA, CROATIA (LOCAL NAME HYVATSKA), CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, ESTONIA, FINLAND, FRANCE, GABON, GERMANY, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MALAYSIA, MALTA, MAURITIUS, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PALESTINE, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA (SLOVAK REPUBLIC), SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, AND VIET NAM. Details
Devices Merit Medical Systems, Inc. Class II Ongoing Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark Details
Devices Carefusion 303 Inc Class II Ongoing Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT. Details
Biologics CryoLife, Inc. Class II Terminated Tennessee; Missouri; Kentucky; Texas Details
Devices Vascular Solutions, Inc. Class II Ongoing Worldwide Distribution - USA Nationwide including the states of AL, AZ, AR, CA, CO, CT, DE, CD, FL, GA, HI, ID, IL ,IN, IA, KY, LA, ME, MD, MA, MI,MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT VA, WA, WV, WI, WY and AUSTRIA, CANDA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, ISRAEL,. ITALY, MEXICO, NETHERLANDS, NORWAY, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM. Details
Biologics Heartland Lions Eye Bank Class II Terminated Missouri Details
Food Tumalo Farms LLC Class II Terminated WA and OR only Details
Devices Ansell Healthcare Products LLC Class II Ongoing .Nationwide Distribution including the states of AL, AZ, CA, CO, DE, FL, GA, IA, IN, IL, KS, KY, LA, MI, MN, MO.MS, NC, NH, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WI and UT. Details
Devices ConMed Corporation Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia. Details
Devices Maquet Cardiovascular Us Sales, Llc Class II Ongoing Worldwide Distribution-USA including the states of AZ, CO, FL, TN, and TX and the countries of Australia, Canada, Czech Republic, Dubai/Bahrain/Kuwait/Lebanon/Saudi Arabia/Yemen, France, Germany, Hong Kong, Italy, Japan, Netherlands, Singapore, South Africa, Sweden, Switzerland, Thailand, Turkey, and UK. Details
Devices Animas Corporation Class III Ongoing Worldwide Distribution-USA (nationwide) including Washington, DC, Puerto Rico, US Virgin Island 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Austria, Australia, Bermuda, Canada, New Zealand, Czech Republic, Italy, France, Finland, Hungary, Israel, United Kingdom, Spain, Sweden, Norway, Denmark, Germany, Mexico and Ireland. Details
Devices Varian Medical Systems, Inc. Oncology Systems Class II Ongoing Worldwide Distribution - USA Nationwide Details
Devices Greiner Bio-One North America, Inc. Class II Ongoing US Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA Details
Devices Elekta, Inc. Class II Ongoing Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI. Details
Devices Medrad Inc Class II Ongoing Worldwide Distribution including USA nationwide. Details
Food Nestle USA Class II Ongoing Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI & WY. Details
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