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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Belle Bonfils Memorial Blood Center Class II Terminated AZ Details
Biologics Belle Bonfils Memorial Blood Center Class II Terminated Colorado, Switzerland Details
Biologics Community Blood Center of Greater Kansas City Class II Terminated MO Details
Biologics Biomat USA, Inc. Class II Terminated Spain Details
Biologics American Red Cross Blood Services Class II Terminated OK, KY Details
Biologics American National Red Cross (The) Class II Terminated Blood products were released for distribution to consignees located in CA. Details
Biologics Community Blood Center of Greater Kansas City Class II Terminated MO Details
Biologics Community Blood Center of Greater Kansas City Class II Terminated MO Details
Biologics Community Blood Center of Greater Kansas City Class II Terminated MO Details
Biologics American National Red Cross (The) Class III Terminated IN Details
Biologics Mississippi Valley Reg Bld Ctr Class III Terminated Illinois Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Kentucky Details
Biologics Belle Bonfils Memorial Blood Center Class II Terminated CO, CA, Switzerland Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated NE Details
Biologics Bio-Blood Components, Inc. Class III Terminated California. Details
Biologics Community Blood Center Of Gtr KC Class III Terminated KS. Details
Biologics Mississippi Valley Regional Blood Center Class II Terminated Iowa Details
Biologics Mississippi Valley Regional Blood Center Class II Terminated Missouri, Iowa Details
Biologics Mississippi Valley Regional Blood Center Class II Terminated Washington, D.C. Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated FL Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Iowa Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated NE Details
Biologics Belle Bonfils Memorial Blood Center Class II Terminated MI, Switzerland Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Pennsylvania Details
Biologics American Red Cross Blood Services Class II Terminated NE Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Iowa, Illinois Details
Biologics Delta Blood Bank Class II Terminated CA. Details
Biologics Belle Bonfils Memorial Blood Center Class II Terminated CO, Switzerland Details
Biologics Delta Blood Bank Class II Terminated CA and Austria Details
Biologics Mississippi Valley Regional Blood Center Class II Terminated California, Missouri and Maryland Details
Biologics Blood Centers of the Pacific Class III Terminated CA. Details
Biologics American Red Cross Blood Services Class II,Class III Terminated TX, CA Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Biologics Plasma Care, Inc. dba Marion Blood Plasma, Inc. Class II Terminated California. Details
Biologics Belle Bonfils Memorial Blood Center Class II Terminated CO, Switzerland Details
Biologics American National Red Cross (The) Class II Terminated KY, IN Details
Biologics Blood Center of Northcentral Wisconsin, Inc. Class II Terminated WI, NY Details
Biologics CSL Plasma, Inc. Class II Terminated IL, NC, CA. Details
Biologics Csl Plasma Inc Class II Terminated Illinois Details
Biologics Delta Blood Bank Class II Terminated CA. Details
Biologics New Life Generation, INC. Class II,Class III Ongoing IN, CA, VA Details
Biologics Allograft Innovations, LLC Class III Ongoing Products were distributed domestically to hospitals nationwide and internationally to Israel, South Korea, United Kingdom, and Turkey. Details
Biologics Delta Blood Bank Class III Terminated CA, IN. Details
Biologics Delta Blood Bank Class III Terminated CA, IN. Details
Biologics San Antonio Eye Bank Class III Terminated CA, TX, FL Details
Devices Stryker Medical Division of Stryker Corporation Class II Ongoing Worldwide Distribution -- USA (nationwide) including the states of AK, AL, AZ, CA, FL, ID, IN, KS, KY, LA, MA, MD, MN, MO, NC, NJ, NY, OR, PA, TN, TX, UT, UT, VA, WA, WI, and WV, and the country of Canada. Details
Drugs Morton Salt Co. Class III Ongoing Nationwide & PR & Ireland. Details
Biologics Siemens Healthcare Diagnostics Inc. Class II Ongoing Product was released for distribution in US and Internationally. The firm stated that National Competent Authorities notified in affected countries: Brazil, Thailand, and South Africa. Details
Veterinary Diamond Pet Foods Class I Ongoing Distribution was made to AR, CO, IL, KY, LA, MI, MN, MO, OK, NE, PA, SD, TN, TX, and WI, Details
Drugs The Menz Club, LLC Class I Ongoing Nationwide Details
Devices Exactech, Inc. Class II Ongoing Nationwide distribution: USA including states of: AL, AZ, CO, FL, GA, IL, LA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TN, VA, and WA. Details
Biologics SightLife Class II Terminated One cornea was shipped to each of 2 physicians in Japan. Details
Devices Abbott Point Of Care Inc. Class II Ongoing Worldwide Distribution - US Nationwide, International Details
Devices Sunquest Information Systems, Inc. Class III Completed US Nationwide Distribution Details
Devices Siemens Healthcare Diagnostics, Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of Canada, France, Germany, Spain, Portugal, Italy, Japan, Norway, Australia, Austria, New Zealand, Belgium, Switzerland, Netherlands, Malaysia, Slovenia, South Korea, Denmark, Saudi Arabia, Slovakia, Taiwan, Philippines, Czech Republic, and Singapore. Details
Veterinary Mars Petcare USA Class I Ongoing Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI & WV. Details
Food Breadfarm Class II Terminated Distributed to retailers and direct accounts in Washington State. Details
Drugs Noven Pharmaceuticals, Inc. Class II Ongoing Nationwide and Puerto Rico. Details
Food KT Specialty Foods Inc. Class II Ongoing Products are distributed in Oregon and Washington Details
Drugs Victus, Inc. Class II Ongoing FL Details
Food Peoples Bakery Inc Class I Ongoing Mercer/Burlington counties in NJ Details
Devices Mckesson Medical Imaging Group Class II Ongoing Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom. Details
Devices Medtronic Navigation, Inc. Class II Ongoing Worldwide Distribution - USA, including the states of AL, CO, FL, IA, MI, IA, NC, NE, NY and the countries of South Africa, Italy, and Spain. Details
Devices Conformis Inc Class II Ongoing Worldwide Distribution - US Nationwide and the country of Germany Details
Devices Siemens Medical Solutions, USA, Inc Class II Ongoing Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC. Details
Food LD Amory & Company Class II Ongoing The products were distributed to AZ, NC, and VA. Details
Devices Siemens Healthcare Diagnostics, Inc Class II Ongoing Worldwide Distribution - US Nationwide and the countries of: Foreign: Brazil, China, Denmark, Hong Kong, Malaysia, and New Zealand Viet Nam Details
Devices CareFusion 303, Inc. Class I Ongoing Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa. Details
Devices DePuy Orthopaedics, Inc. Class II Ongoing Worldwide Distribution - USA including PA and the country of Canada Details
Devices Stryker Spine Class II Ongoing Distributed in Atlanta, Georgia. Details
Food Cool Creations, LLC Class I Ongoing Direct distribution was made to KS, MO, and OK. Details
Food Wimberger's Old World Bakery, Inc. Class I Ongoing The product was distributed to retailers located in Colorado and Kansas. Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide Distribution - US Nationwide including the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, and WV and the countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Germany, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Singapore, South Africa, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam Details
Food Freshpoint Atlanta, Inc. Class I Ongoing AL, GA, NC, SC & TN. Details
Food Huxtable's Kitchen Inc Class I Ongoing Distributed to Trader Joes market stores CA, AZ, NV and NM. Details
Devices GE OEC Medical Systems, Inc Class II Ongoing Worldwide Distribution -- USA (nationwide) Details
Food Reshmi's Group Inc. Class I Ongoing Product was further distributed to consignees in Alaska, Colorado, Oregon, and Washington Details
Food Authentic Gourmet Class II Ongoing CA Details
Food Mother India foods LLC Class I Ongoing Distributed in Oregon and Washington Details
Devices Beckman Coulter Inc. Class II Terminated Worldwide distribution: USA (nationwide) and countries of: Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea,Republic of; Kuwait, Liechtenstein, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam. Details
Food Tomales Bay Foods, Inc. Class II Completed Part One: CA, VA, VT, WI, OR, UT and Italy, Spain, Switzerland, France, Holland, Greece. Part Two: Dates of Distribution: 6/2512 - 7/27/12 Pattern: CA, NC, FL Details
Devices GE OEC Medical Systems, Inc Class II Terminated Worldwide and Nationwide (USA) distribution. Details
Devices GE OEC Medical Systems, Inc Class II Terminated Nationwide Distribution. Details
Devices Biomet U.K., Ltd. Class II Ongoing Worldwide Distribution-USA-including the states of IN, SD, and TX and the countries of Austria, China, Japan, Netherlands, Sweden, Turkey, and UK. Details
Devices GE OEC Medical Systems, Inc Class II Ongoing Nationwide distribution. Details
Devices Sunquest Information Systems, Inc. Class III Terminated Worldwide distribution: USA (nationwide) and country of: Bahamas. Details
Devices Beckman Coulter Inc. Class II Terminated Worldwide Distribution-USA (nationwide) including the states GA, NY, IL, TX, WA, PA, IN, MS, NC, and MO and the countries of Belgium, France, Hong Kong, Italy, Spain, and Switzerland. Details
Drugs Prometheus Laboratories Inc. Class II Ongoing Nationwide and Puerto Rico. Details
Drugs Custom Medical Specialties, Inc. Class II Ongoing GA, MD, MA Details
Food 2 Moms in the Raw, LLC Class I Ongoing National US distribution only: OR, NY, KS, PA, CA, TX, NH, WA. Details
Food Deep Foods Inc Class I Ongoing Nationwide. Details
Food Specialty Commodities, Inc. Class I Ongoing CA, MN NJ, NY, OR, PA, SC, and Canada Details
Food Flywheel's Pies Class II Ongoing Arkansas Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution - US Nationwide including the states of: AL, AR, AZ, CA, DC, FL, GA, KY, MD, MI, MN, MS, ND, NM, NY, OH, OK, SC, TN, TX, VT, WA, and WI and the countries of: Austria, China, Denmark, France, Germany, Iceland, Japan, Netherlands, South Africa, Sweden, Switzerland, United Kingdom. There were two government consignees. There were no Canadian consignees. Details
Devices Beckman Coulter Inc. Class III Ongoing Worldwide Distribution - USA (nationwide), Canada, and internationally. Details
Food Menno Beachy Class I Ongoing Distribution was made to a food distributor in MN who further distributed the product to retail stores located in MN, WI, and MI. Details
Devices AGFA Corp. Class II Ongoing USA Nationwide, Virgin Islands and Canada Details
Devices GE OEC Medical Systems, Inc Class II Terminated Worldwide Distribution - USA - Australia, Brazil, Cameroon, China, Colombia, Cyprus, The Czech Republic, Finland, France, Germany, Greece, Italy, Japan, Korea, Malaysia, The Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Taiwan, Turkey, UAE, UK, and Canada. Details
Food Essential Living Foods, Inc Class I Completed CA Details
Food Fresco Green Farms, Inc. Class I Ongoing CA Details
Devices Hitachi Medical Systems America Inc Class II Ongoing US Nationwide Distribution - including the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and Mexico. Details
Devices Galil Medical, Inc. Class II Completed Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Nationwide Distribution-including the states of CO, FL, MD, MN, NE and PA. Details
Drugs VistaPharm, Inc. Class II Ongoing Nationwide Details
Food Winn Dixie Stores, Inc. Class II Ongoing SC Details
Food J&S Group Class II Ongoing CA, IL Details
Food Spartan Central Kitchen Class II Ongoing MI distribution only Details
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