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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida Details
Biologics BioLife Plasma Services LP Class II Terminated CA Details
Biologics Community Blood Centers of South Florida, Inc. Class III Terminated Florida Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida Details
Biologics Delta Blood Bank Class II Terminated CA. Details
Biologics Delta Blood Bank Class II Terminated CA. Details
Biologics Community Blood Centers of South Florida, Inc. Class III Terminated Florida Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida, New York Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated New York Details
Biologics Suncoast Communities Blood Bank, Inc. Class II,Class III Terminated FL, MA, TN, NJ, KY, Puerto Rico Details
Food Trophy Nut Co Inc Class I Terminated Distributed nationwide, including the states of: CA, IL, IN, MD, MI, MN, NC, ND, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT, and VI. Details
Biologics BioLife Plasma Services LP Class II Terminated CA Details
Biologics Talecris Plasma Resources, Inc. Class III Terminated NC Details
Biologics Csl Plasma Inc Class III Terminated Illinois, North Carolina, California, Germany, Switzerland Details
Biologics New York Blood Center, Inc. Class II,Class III Terminated France, UK, NY, NJ, CA Details
Biologics Delta Blood Bank Class II Terminated CA. Details
Food Rio Queen Citrus, Inc Class I Ongoing TX, SC, KS, and Canada Details
Biologics Pacific Coast Tissue Bank Class I Completed nationwide and world wide Details
Food Whole Foods Market Class II Ongoing Domestically, nationwide, and to Canada and the United Kingdom. Details
Drugs Advance Pharmaceutical Inc Class I Ongoing Nationwide Details
Food Southwest Ice Cream Specialties Class I Ongoing Product was distributed in the following states: Arkansas, Arizona, Colorado, Kansas, Oklahoma, New Mexico and Texas. Details
Veterinary Del Monte Foods Corp Class II Ongoing Nationally to >200 consignees Details
Veterinary IMS Trading Corp. Class II Ongoing Nationwide. Details
Biologics Our Lady Of The Lake Hospital Inc Class II Terminated 5 in Louisiana Details
Veterinary Hartz Mountain Corp. Class II Ongoing Nationwide Details
Devices Bard Peripheral Vascular Inc Class II Terminated Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY. Details
Biologics Mississippi Blood Services Inc. Class II Terminated Mississippi Details
Biologics Upstate New York Transplant Services Class II Terminated New York Details
Biologics Plasma Biological Services Class III Terminated California Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Iowa Details
Drugs OLAAX International Class I Ongoing Nationwide, Puerto Rico and Venezuela and Bolivia Details
Biologics Bio-Blood Components, Inc. Class II Terminated California Details
Biologics BloodCenter of Wisconsin, Inc Class II Terminated Wisconsin; Arkansas Details
Biologics Blood Systems, Inc. dba United Blood Services Class III Terminated Texas Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Kansas Details
Biologics Blood Systems Inc Class II Terminated Arizona Details
Biologics Florida's Blood Centers, Inc. Class II Terminated Florida Details
Veterinary Diggin Your Dog, LLC Class I Terminated NV and CO Details
Biologics DCI Biologicals Carbondale, LLC Class II Terminated California Details
Biologics Hoxworth Blood Center UC Medical Center Class II Terminated Ohio Details
Biologics Mercy Hospital St Louis Class II Terminated Missouri Details
Biologics Mercy Hospital St Louis Class II,Class III Terminated Missouri; California Details
Biologics LifeShare Blood Centers Class II Terminated Texas Details
Food Purely American, Inc. Class II Ongoing Product was shipped to the following states: CT, DE, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, NE, NJ, NY, OH, PA, SD, VA & WV. Details
Biologics Terumo Bct Class II Ongoing National and global distribution. Details
Biologics AlloSource, Inc. Class I Terminated Michigan; Alabama; North Carolina Details
Biologics Fenwal Inc Class III Ongoing US (CA, OR, OH, MI) Details
Devices Bard Peripheral Vascular Inc Class II Ongoing Worldwide Distribution: USA Nationwide and Internationally to Europe. Details
Drugs Teva Pharmaceuticals USA, Inc. Class III Ongoing Nationwide Details
Food Pure Herbs Ltd Class I Ongoing The Pure Herbs products are sold to a network of independent distributors/consumers. Details
Devices DePuy Orthopaedics, Inc. Class II Ongoing Worldwide Distribution - USA Nationwide and countries of: Australia, Canada, Czech Republic, England, Germany, Switzerland and Turkey. Details
Devices OrthoPediatrics Corp Class II Ongoing USA Nationwide Distribution Details
Food Hazelnut Growers of Oregon Class I Ongoing distributed in Canada only. Details
Devices American Optisurgical Inc Class II Ongoing Worldwide Disitribution - USA Nationwide in the states of Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming and the countries of Quezon City, Philippines, Singapore, and Panama City, Panama. Details
Food Atlantic Pro Nutrients, Inc. dba XYMOGEN Class I Ongoing AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia and Hawaii Details
Food Dairy Fresh LLC Class I Ongoing FL, GA KY, NC, OH, PA, SC, TN and WV. Details
Devices Edwards Lifesciences, LLC Class II Ongoing Worldwide distribution: US Nationwide and country of Canada. Details
Devices Embla System Llc Class II Ongoing Worldwide distribution: US (nationwide) including states of: CO, AK, WA, CA, WI, MI, MA OH, DE, FL CA, CT, TX, IL, GA, PA, AZ, DC, VA, MD, UT, IN, MO, NY, NC, OR, NV, NJ, NH, DE, and country of: Canada. Details
Devices Siemens Healthcare Diagnostics, Inc. Class II Ongoing Nationwide Distribution. Details
Food Berkshire Cheese LLC Class III Completed MA Details
Devices Applied Medical Resources Corp Class II Ongoing Worldwide Distribution: USA Nationwide and countries of: Argentina, Austria, Australia, Bahrain, Belgium, Canada, Chile, Columbia, Denmark, Ecuador, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Jordan, Kuwait, Malaysia, Lebanon, Lybia, Mexico, Netherlands, New Zealand, Pakistan, Peru, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Spain, South Africa, Switzerland, Taiwan-Province of China,Turkey, United Arabs Emirates United Kingdom, Uruguay, and Venezula-Bolivarian Republic. Details
Devices Endologix Inc Class I Ongoing Worldwide Distribution - USA Nationwide in the states of: NY, NH, IN, MI, FL and NJ and in the countries of: Europe and Latin America. Details
Devices Dental EZ Stardental Division Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of CA, FL, IA, IN, NJ, NV, NY, PA, TN, TX, and WI, and the country of Japan. Details
Devices Abbott Medical Optics, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Great Britian, Greece, India, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Singapore, Sweden, Turkey, Japan, Spain, Chile, Argentina, Colombia, Brazil, Taiwan, Mexico, South Korea, Venezuela, Paraquay, South Korea, Russian Federation, Costa Rico, Portugal, Uruquay, Martinique, Israel, Bolivia, Ecuador, Lebanon, Thailand, Saudi Arabia, Egypt, Dominican Republic, United Arab Emirates, Czech Republic, Indonesia, Kuwait, Ukraine, Guatemala, Phillipines, Trinidad, Tobago, Mongolia, Jordan, Malaysia, Hong Kong, Bulgaria, Oman, Kazakhstan, Bulgaria, Peru, Bolivia, Croatia, Romania, Yemen, Vietnam, Uzbekistan, Libyia, Slovakia, Algeria, El Salvador, and Cyprus. . Details
Food Blessing Seafood, Inc. Class I Ongoing The 16-20 EZ Peel Shrimp was distributed by Perishable Distributors of Iowa (PDI) and sold from February 12 to May 23, 2013 at the seafood display counters in the retail markets seafood section of Hy-Vee stores located in eight states: Iowa, Nebraska, Kansas, Illinois, Missouri, South Dakota, Minnesota, and Wisconsin, and at Cedar Valley Fish Market in Waterloo, Iowa. Details
Devices Fenwal Inc Class II Ongoing USA Nationwide Distribution Details
Food Fruit Treasure Inc Class I Ongoing Within California. Details
Drugs Sandoz Incorporated Class II Ongoing Nationwide and Puerto Rico. Details
Devices Ethicon Endo-Surgery Inc Class II Ongoing Worldwide Distribution - US Nationwide all fifty states and including the countries of Canada, Belgium, India, Malaysia, Saudi Arabia, Brazil, Israel, Mexico, Singapore, Jordan, New Zealand, Taiwan, Chile, Korea, Puerto Rico, Turkey, Columbia, Kuwait, Qatar, United Arab Emirates, Egypt, Lebanon and Russia. Details
Drugs Actavis Class III Ongoing Nationwide Details
Food International Desserts and Delicacies Class I Ongoing Nationwide to retail grocery stores. Details
Devices International Biomedical, Ltd. Class II Ongoing Nationwide Distribution. Details
Food American Importing Co, Inc Class II Ongoing One main customer, Target Corporation with 52 distribution locations. AL, AZ, CA, CO, GA, IL, IN, IA, KS, MI, MN, NY, NC, OH, OR, PA SC, TX, VA, WI. Details
Devices Utah Medical Products, Inc Class II Ongoing Worldwide Distribution - United States Nationwide in the states of (MO, NE, KY, FL, OH, NY), and countries of Columbia, Brazil, Venezuela. West Indies, Latin America, Ecuador are distributed through a US direct consignee exporter. Details
Devices Bard Peripheral Vascular Inc Class II Ongoing US Nationwide Distribution Details
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