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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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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