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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics American National Red Cross (The) Class II Terminated Arizona Details
Biologics American National Red Cross (The) Class III Terminated AZ Details
Biologics Southern California Permanente Medical Group Blood Donor Center Class III Terminated CA Details
Biologics Southern California Permanente Medical Group Blood Bank Class II Terminated CA Details
Biologics Southern California Permanente Medical Group Blood Donor Ctr Class II Terminated CA Details
Biologics Blood Bank of San Bernardino and Riverside Counties Class II Terminated California, Washington DC, Switzerland Details
Biologics HemaCare Corporation Class II Terminated California Details
Biologics Southern California Permanente Medical Group Blood Bank Class II Terminated CA Details
Biologics The American National Red Cross South Carolina Region Class II Terminated SC Details
Biologics BloodNetUSA, Inc. Class II Terminated Florida Details
Biologics American National Red Cross (The) Class II Terminated Illinois, New York Details
Biologics HemaCare Corporation Class II Terminated California Details
Biologics Southern California Permanente Medical Group Blood Bank Class II Terminated CA Details
Biologics Blood Bank of San Bernardino and Riverside Counties Class II,Class III Terminated California Details
Biologics The American National Red Cross South Carolina Region Class II Terminated SC Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida Details
Biologics Southern California Permanente Medical Group Blood Donor Center Class II Terminated CA Details
Biologics Blood Bank of San Bernardino and Riverside Counties Class II Terminated California Details
Biologics Southern California Permanente Medical Group Blood Donor Center Class II Terminated CA Details
Biologics The American National Red Cross South Carolina Region Class III Terminated SC Details
Biologics American National Red Cross (The) Class II Terminated NY Details
Biologics CSL Plasma Inc Class II Terminated IL, CA, Switzerland Details
Biologics Department of the Navy Class III Terminated NJ Details
Biologics American National Red Cross Class II Terminated NC, ID , UT ,OR, MT, WY, CA, AZ Details
Biologics Community Blood Center Of Gtr KC Class III Terminated MO; KS; IL Details
Biologics American National Red Cross (the) Class II Terminated NC Details
Food Caribe Produce Class I Ongoing NJ and NC Details
Food Christian Cheese, LLC Class II Ongoing CO and OK Details
Food Food Source, Inc Class I Ongoing Nationwide Details
Food GHSW, LLC Class I Ongoing FL, LA, and TX Details
Food Del Monte Fresh Produce North America, Inc Class I Ongoing Product was distributed directly to the states of Florida, Georgia, Missouri, North Carolina, Ohio, and Texas. Product was then shipped further from the firm's direct accounts. Details
Drugs Teva Pharmaceuticals USA, Inc. Class III Ongoing Nationwide and Puerto Rico Details
Drugs Teva Pharmaceuticals USA, Inc. Class III Ongoing Nationwide distribution. No foreign or government accounts. Details
Biologics Coastal Bend Blood Center Class II Terminated Texas Details
Biologics Arc Blood Services, New England Region Class II Completed Tennessee; New Hampshire; Vermont; Massachusetts; Maryland; Maine; New York Details
Devices Toshiba American Medical Systems Inc Class II Ongoing US Nationwide Distribution Details
Biologics University Of Miami Miller School of Medicine Tissue Bank Class II Terminated Greece Details
Devices Fresenius Medical Care Holdings, Inc. Class II Ongoing Nationwide Distribution including the states of AR, CA, FL, GA, KY, LA, MA, MD, NC, NJ, NY, PA, PR, SC, TX and VA. Details
Devices SagaTech Electronics, Inc. Class II Completed Worldwide Distribution:US (nationwide) and countries of:Canada and Mexico. Details
Biologics University Of Miami Miller School of Medicine Tissue Bank Class II Terminated California Details
Devices Baxter Healthcare Corp. Class II Ongoing US Nationwide Distribution Details
Biologics TissueTech, Inc. dba Bio-Tissue, Inc. Class II,Class III Terminated Nevada; Illinois; New Mexico; Arizona; Alabama; Oregon; Ohio; Florida; California; Washington; Louisiana; Texas Details
Food Eco-Cuisine Class II Ongoing Nation wide distribution and Canada. Details
Drugs Fresenius Kabi USA, LLC Class III Ongoing Nationwide and Puerto Rico Details
Drugs Hospira Inc. Class II Ongoing Nationwide Details
Food Chs Inc Class I,Class II Ongoing Nationwide. Product was shipped from the Israel facility to the following countries. This product did not come into the U.S. before shipment to the following countries: Canada, Australia, Belgium, Brazil, Bulgaria, Chile, Columbia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Japan, Lithuania, Mauritius, Mexico, Netherlands, New Zealand, Panama, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom, Uruguay, and Vietnam Details
Biologics OneBlood / dba CBCF Class II Terminated Florida Details
Food Mother Earth International LLC Class II Ongoing Distribution was nationwide through internet sales. No foriegn or military distribution was made. Details
Biologics Community Blood Centers of South Florida, Inc. Class II,Class III Terminated Florida Details
Drugs West-ward Pharmaceutical Corp. Class III Ongoing Nationwide Details
Devices Zimmer, Inc. Class II Ongoing Nationwide Distribution including IL and MO. Details
Devices Abbott Medical Optics, Inc. Class II Ongoing Worldwide Distribution, including Nationwide (US) and countries in Latin America, EMEA, and APAC. Details
Food Salmolux (A Pacific Seafood Group Company) Class I,Class II Ongoing Products were distributed in Arkansas, Arizona, California, Idaho, Michigan, Nevada, New York, Ohio, Texas, and Washington. Details
Devices Boston Scientific Corporation Class II Ongoing Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain. Details
Devices Linvatec Corp. dba ConMed Linvatec Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, GA, IL, IN, KS, MO, NC, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, and WI, and the countries of Austria; Belgium, Canada, China, Czech Republic, Finland, France, Great Britain, Italy, and Japan. Details
Food Finger Lakes Farmstead Cheese Company Llc Class I,Class II Ongoing 1 firm in NY State. Details
Food ABCO Laboratories, Inc. Class II Ongoing CA and PA. Details
Devices Fresenius Medical Care Holdings, Inc. Class II Ongoing Nationwide Distribution Details
Devices Boston Scientific Corporation Class III Ongoing Worldwide Distribution - USA Nationwide including the state of NY, NE, MD, OH, TX, PA, VA, PR, CA, NJ, NY, CA and the countries of: AT, FR, DE, GB, IL, IT, LB, NL, ES, SE, TN, Argentina, and Japan. Details
Food Creole & Company, LLC Class I Ongoing LA Details
Food ARO Pistachios, Inc. Class I Ongoing CA, TX, MN, OR, NY, MI, UT, IA, AL, VA, NJ,AZ, GA, PA. and FL, IL, SC, OH, MA, NE, KY, UT, CT, LA, IN, DC, KS, OK, NH,, RI,, NC, MD, AK, Details
Food Lipari Foods, Inc. Class I Ongoing Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana. Details
Food Allergy Research Group Class II Ongoing Distributors, Wholesalers, healthcare providers and retail customers in the USA. Nutrilink in England and DeltaStar in the Netherlands are distributors in Europe. Details
Food Palmer Candy Co Class I Ongoing Distribution made to TN, ND, NE, IL, SD and MO. No foreign or military/government distribution made. Details
Devices Medtronic MiniMed Class I Ongoing Worldwide distribution: US (nationwide) distribution: Algeria, Argentina, Australia, Bahamas, Bahrain, Bermuda, Boliva, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Southern Territories, Germany, Great Britain, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Macedonia, Malaysia, Mexico, Morocco, Netherlands, Norway, New Zealand, Oman, Panama, Paraguay, Peru, Poland, Province of China, Taiwan, Qatar, Republic of Korea, Romania, Russia Federation, Saint Lucia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, Uruguay, and Venezuela. Details
Devices Angiodynamics, INC Class II Ongoing Worldwide Distribution, including the US, Austria, China, Italy, Russia and the UK. Details
Food Hines Nut Co Class I Ongoing AR, MN, PA, and TX Details
Devices Bryan Medical Inc Class I Ongoing Distributed in KY and AL. Details
Devices Biomet, Inc. Class II Ongoing Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands. Details
Devices Cardio Medical Products Class II Ongoing Nationwide Distribution Details
Food Western Mixers Produce & Nuts, Inc. Class I Ongoing CA, OH, UT, FL, WA, NV, OR, AZ, TX Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing United States Nationwide Distribution in the states of ND, OH and SC. Details
Drugs Sun Pharmaceutical Industries Inc. Class II Ongoing Nationwide and Puerto Rico Details
Devices Integra LifeSciences Corp. Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, and WA and the countries of Canada, Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Spain, Finland, France, Ireland, Israel, Italy, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, United Arab Republic, United Kingdom, and South Africa. Details
Food Garden-Fresh Foods, Inc. Class II Ongoing IA, FL, TX Details
Food Granna's, LLC Class I Ongoing All product was distributed in Oklahoma. Details
Devices DeRoyal Industries Inc Class II Completed USA Nationwide Distribution in the state of PA Details
Food Torn & Glasser Inc. Class I Ongoing CA, AZ, and HI. Details
Food R.L. SCHREIBER INC - LEBANON Class III Ongoing The affected product was distributed to the following states:AZ, CA, CO, FL, ID, IL, MA, MI, MO, NC, NJ, NV, OH, OR, PA, TN, and WA. Details
Devices Baxter Healthcare Corp. Class II Ongoing Worldwide Distribution - USA (nationwide), Puerto Rico and Internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Czech Republic, Denmark (including Faroe Islands), Ecuador, Finland, France (including Martinique and Reunion Islands), Germany, Greece, Iceland, India, Ireland, Isreal, Italy, Luxemburg, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweded, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom. Details
Drugs Fresenius Kabi USA, LLC Class II Ongoing Nationwide & Puerto Rico Details
Devices Intuitive Surgical, Inc. Class II Ongoing Worldwide Distribution - USA including UT, CA, AZ, CO, FL, HI. MT, NY,TX and WA and one customer in Russia. Details
Food GKI Foods, LLC Class II Ongoing Traverse City, MI. One customer. Details
Food Los Milagros Tortilleria, LLC Class II Ongoing AZ Details
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