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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics ZLB Bioplasma, Inc. Class III Terminated IL, CA Details
Biologics Blood Bank Of San Bernardino and Riverside Counties Class II,Class III Terminated CA, Switzerland Details
Biologics CSL Plasma Inc Class III Terminated CA Details
Biologics Hoxworth Blood Center University of Cincinnati Medical Center Class II Terminated Kentucky, Ohio. Details
Biologics ZLB Bioplasma, Inc. Class II Terminated NC Details
Biologics Department of the Air Force Class II Terminated New Jersey Details
Biologics Tri-counties Blood Bank Class II Terminated CA Details
Biologics Creative Testing Solutions Class II Terminated AZ Details
Biologics ZLB Bioplasma, Inc. Class II Terminated IL, IN Details
Biologics Tri-counties Blood Bank Class II Terminated California Details
Biologics Tri-counties Blood Bank Class III Terminated California Details
Biologics Central Kentucky Blood Center Inc Class II Terminated Kentucky Details
Biologics Blood Bank Of San Bernardino And Riverside Counties Class II Terminated CA, Austria Details
Biologics BioLife Plasma Services L.P. Class II Terminated California Details
Biologics Blood Bank of San Bernardino and Riverside Counties Class II,Class III Terminated California, Florida, Washington, D.C., Austria Details
Biologics Tri-counties Blood Bank Class II Terminated California Details
Biologics Tri-counties Blood Bank Class II Terminated CA Details
Biologics Tri-counties Blood Bank Class III Terminated CA Details
Biologics American National Red Cross (The) Class II Terminated Arizona, California Details
Biologics Tri-counties Blood Bank Class II Terminated CA Details
Biologics Southern California Permanente Medical Group Blood Donor Center Class II Terminated CA Details
Biologics Tri-counties Blood Bank Class II Terminated CA Details
Biologics Hoxworth Blood Center University of Cincinnati Medical Center Class II Terminated Ohio. Details
Biologics Hoxworth Blood Center University of Cincinnati Medical Center Class II Terminated Kentucky, Ohio. Details
Biologics Hoxworth Blood Center University of Cincinnati Medical Center Class II Terminated OH Details
Biologics ZLB Bioplasma, Inc. Class II Terminated IL, Germany. Details
Biologics St. Thomas More Hospital Blood Bank Class III Terminated CO Details
Devices St. Jude Medical Class II Ongoing Worldwide Distribution--USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Belgium, Brazil, canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Saudi, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom. Details
Devices Leica Microsystems, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Brazil, Chile, France, Germany, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, Philipines, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, and United Kingdom. Details
Drugs Green Planet Inc Class I Completed Nationwide. Details
Devices Acclarent, Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia. Details
Biologics OneBlood, Inc. Class II Terminated Florida Details
Biologics Community Blood Centers of South Florida, Inc. Class II Completed Michigan, Florida Details
Devices SpineFrontier, Inc. Class II Ongoing US distribution in states of: CO, DC, MA and TX. Details
Biologics LifeShare Blood Centers Class II Terminated Louisiana Details
Biologics LifeShare Blood Centers Class II Terminated Louisiana Details
Biologics Community Blood Centers of South Florida, Inc. Class II,Class III Terminated Florida Details
Devices SpineFrontier, Inc. Class II Ongoing US distributions to states of: KS and TX. Details
Biologics American National Red Cross (The) Class III Terminated Wisconsin Details
Devices Custom Spine, Inc. Class II Ongoing Nationwide Distribution including Nebraska and Virginia. Details
Devices Wako Life Sciences, Inc. Class II Ongoing Distribution to CA, GA, MN, NC, UT and the District of Columbia. Details
Biologics Alba Bioscience Limited Class III Terminated Multiple U.S. States Details
Devices HeartWare Inc Class II Ongoing Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom. Details
Drugs Actavis South Atlantic LLC Class II Ongoing Nationwide Details
Biologics One Lambda Inc Class II Ongoing USA, Canada, Germany, Israel, Poland, Spain, Brazil, Japan, Singapore, Thailand, and Vietnam. Details
Biologics International Sight Restoration, Inc. Class III Terminated Israel and Florida Details
Devices Beckman Coulter Inc. Class II Ongoing Worldwide Distribution, including Nationwide (US) and the countries of China, Italy, Japan, Canada, Turkey, United Kingdom, Singapore, Israel, and the Netherlands. Details
Drugs Warner Chilcott US LLC Class II Ongoing Nationwide Details
Food Oskri Corp. Class I Ongoing CA, CT, FL, ID, IL, IA, ME, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX, VT, VA, WA, WV, WI. Details
Devices Steritec Products Mfc. Co., Inc. Class II Ongoing Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey. Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing US Distribution including the states of CA, IN, NJ and OK. Details
Devices Accelerated Care Plus Corporation Class II Ongoing Nationwide Distribution. Details
Food El Campestre Class I,Class II,Class III Ongoing CA Details
Devices Mesa Laboratories, Inc., Bozeman Manufacturing Facility Class II Ongoing Worldwide Distribution: US (nationwide) and countries of: Australia, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Egypt, Greece, India,Israel, Japan, Jordan, Malaysia, Mexico, Milanese, Netherlands, Peru, Portugal, Pozan, Romania, Spain, Sweden, Taiwan, Thailand, United Kingdom, and Uruguay. Details
Devices Exactech, Inc. Class II Ongoing US Distribution including the states of AR, CA, FL, NJ, NY, OK, and TX Details
Devices Tosoh Smd Inc Class II Ongoing Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. Internationally to Canada, Japan, Mexico, Chile, and Uruguay. Details
Food Church & Dwight Inc Class II Ongoing Nationwide Details
Devices DePuy Orthopaedics, Inc. Class I Ongoing Worldwide Distribution-USA including the states of FL, GA, ID, KS, KY, MI, MO, NV, NY, OH, OK, PA, TN, TX, VA, and WA and the countries of AUSTRALIA, CANADA, ENGLAND, GERMANY, INDIA, COUNTY CORK, IRELAND, and TURKEY. Details
Drugs Physicians Total Care, Inc. Class II Completed GA Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing US Distribution only including the states of PA, OH, UT, CA, NY, MO, and TX. Details
Devices Hospira Inc. Class II Ongoing US Distribution including the states of AL, CA, CT, DE, FL, HI, IA, IL, IN, LA, MA, MD, ME, MI, MN, NC, NJ, NY, PA, SD, TX and WA. Details
Devices Becton Dickinson & Co. Class II Ongoing Nationwide Distribution Details
Food Fisher's Homestyle Salads Class I,Class II Ongoing 1. Esh Foods, L.L.C., located at 58 Hatville Rd; Gordonville, PA 17529 tel # 717-768-8542 Contact: David Esh 2. Landis Foods, located at 679 Hartman Station Road, Lancaster, PA 17602 Tel 717-397-5382 Contact: Lloyd Miller 3. Soup R Salads, located at 2268 Old Philadelphia Pike, Lancaster, PA 17602 Tel # 717-295-3105 Contact: Steve Shenk. Additional quantities (approximately 140 lbs) were sold to customers from the on-site retail counter at Fisher's Homestyle Salads, LLC. Details
Devices Stryker Howmedica Osteonics Corp. Class II Ongoing US Distribution including the states of IL, KY and TN. Details
Drugs Procter & Gamble Co Class II Ongoing Nationwide Details
Food Ozark Bottling, LLC Class III Ongoing Distribution was made to OH. Details
Devices Picis Inc. Class II Ongoing Nationwide Distribution, including the states of: AK, AR, AZ, CA, CO, DC, DE, FL, GA, ID, IN, MA, MD, MO, NH, NJ, OH, OR, SC, TN, WA, and WV. Details
Devices Synthes USA HQ, Inc. Class II Ongoing US distribution: PA only. . Details
Devices Synthes USA HQ, Inc. Class II Ongoing US Distribution including the states of CA, MN, NC and TN. Details
Cosmetics Sunflower Hill Class II Ongoing ME, VA. Product sold only in two LL Bean stores. No online sales. Details
Devices Sotera Wireless, Inc. Class II Ongoing US distribution including CA and UT. Details
Food Hagee Foods Inc. Class I Ongoing Products were directly distributed in Oregon and Washington. Details
Food Whole Foods Market Mid-Atlantic Kitchen Class I Ongoing The product was distributed to Kentucky, Maryland, Pennsylvania, Ohio, Virginia, Washington D.C. and New Jersey. Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution - US Distribution including the states AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, LA, MD, MI, MN, MO, NE, NV, NM, NY, NC, OH, OR, PA, SC, SD, TN,TX, VA, WA and WI., and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRIL, CANADA, CHINA, COLOMBIA, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, INDIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF MOLDOVA, NETHERLANDS, NORWAY, POLAND, ROMANIA, RUSSIAN FEDERATION, KINGDOM OF SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA. Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, DE, FL, GA, ID, IL , IA, MD, MA, MI, MS, MO, NJ, NM, NY, NC, OH, PA, RI, SC, TN,TX, UT,VT, VA and WI., and the countries of ARAB EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, HONG KONG, INDIA, ITALY, JAPAN, NETHERLANDS,NEW ZEALAND, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SINGAPORE,SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND and UNITED EMIRATES. Details
Food Kabco Pharmaceuticals, Inc. Class II Completed New York Details
Food CSM Bakery Products North America Class II Ongoing CA, FL, GA, IL, IN, MO, NC, NY, OH, OK, PA, TX, UT, WI, and WY Details
Food Northwest Gourmet Food Products, Inc. Class I Ongoing Distributed in Washington Details
Drugs Torrent Pharma Inc Class II Ongoing Nationwide Details
Drugs Baxter Healthcare Corp. Class II Ongoing Nationwide and Puerto Rico Details
Food Lipari Foods, Inc. Class I Ongoing Ohio, Michigan, Minnesota, West Virginia, Kentucky, Pennsylvania, Illinois, and Indiana Details
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