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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Devices Sechrist Industries Inc Class II Terminated Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada Details
Devices Medacta Usa Inc Class II Completed Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium. Details
Drugs Aurobindo Pharma LTD Class II Ongoing Nationwide Details
Devices Shimadzu Medical Systems Class II Ongoing US Nationwide Distribution Details
Devices Sysmex America, Inc. Class II Ongoing Nationwide distribution: USA including Puerto Rico. Details
Veterinary Land O Lakes Purina LLC Class I Ongoing WI Expanded Recall: AL, AR, CA, CO,FL, GA, IA, IL, IN, KY, KS, MS, MI, MN, MO, NC, NE, NY, NM, OR, OH, OK, PA , SC, SD, TN, TX, WI. Details
Biologics Community Blood Centers of Florida, Inc. Class II,Class III Terminated Pennsylvania; Florida; New York Details
Biologics Community Blood Centers of Florida, Inc. Class II Terminated Florida Details
Biologics Central Jersey Blood Center, Inc. Class II Terminated New Jersey Details
Biologics Community Blood Centers of Florida, Inc. Class II Terminated Florida Details
Biologics Hoxworth Blood Center UC Medical Center Class II Terminated Ohio Details
Biologics The American National Red Cross - Southern Region Class III Terminated California Details
Biologics Mississippi Blood Services Inc. Class II Terminated Mississippi Details
Devices Siemens Healthcare Diagnostics, Inc. Class III Ongoing USA (nationwide) including the states of AL, CA, CO, CT, DC, DE, FL, IA, IL, IN, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA and WI. Details
Biologics LifeSouth Community Blood Centers Inc - Birmingham Region Class II Terminated Alabama Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated Alabama Details
Biologics LifeSouth Community Blood Centers Inc - Birmingham Region Class II Terminated Alabama Details
Biologics Walter L. Shepeard Community Blood Center, Inc. Class II Terminated Georgia Details
Biologics Community Blood Centers of Florida, Inc. Class II,Class III Terminated Florida; New Zealand Details
Biologics Community Blood Centers of South Florida, Inc. Class II,Class III Terminated Switzerland; Florida Details
Biologics Florida's Blood Centers, Inc. Class II Terminated Florida Details
Biologics Community Blood Centers of Florida, Inc. Class II Completed Florida; New York Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Iowa; New Jersey Details
Biologics Blood Systems Inc Class II Terminated Arizona Details
Biologics Suncoast Communities Blood Bank, Inc. Class II Terminated Florida Details
Biologics Mississippi Valley Reg Bld Ctr Class III Terminated Missouri Details
Biologics Memorial Blood Centers Class II Terminated Minnesota Details
Biologics Memorial Blood Centers Class II Terminated Switzerland; Minnesota Details
Biologics Memorial Blood Centers Class II Terminated Minnesota Details
Biologics Interstate Blood Bank, Inc. of Wisconsin Class II Terminated California; Germany, Federal Republic of Details
Biologics Interstate Blood Bank, Inc. of Wisconsin Class II Terminated California Details
Biologics Carter BloodCare Class II,Class III Terminated Austria; Texas Details
Biologics Blood Assurance Inc Class III Terminated Tennessee Details
Devices Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. Class II Ongoing Worldwide Distribution - USA including DE,IL, NC, CA, CO, GA, KY, PA, MD, MN, NY, and MA and internationally to Austria, UAE, China, Argentina, Italy, Taiwan, Czech Republic, Australia, UK, India, Germany, Spain, France, South Africa, Malaysia, Japan, Lebanon, Korea, Greece, Saudi Arabia, Switzerland, Pakistan, Tunisia, Serbia, Morocco, Netherlands, Portugal, Truk, Belgium, and New Zealand Details
Biologics LifeShare Blood Centers Class II Terminated Switzerland Details
Biologics ITXM Clinical Services Class III Terminated Pennsylvania Details
Biologics Community Blood Centers of South Florida, Inc. Class II,Class III Terminated Florida; New Zealand Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida Details
Biologics Community Blood Centers of Florida, Inc. Class II Terminated Florida Details
Biologics Community Blood Centers of South Florida, Inc. Class II,Class III Terminated Florida; New Zealand Details
Food Giant Eagle Class I Ongoing Product was distributed within the US to select supermarkets (not under the Giant Eagle banner) in OH AND PA. Details
Devices Primus Medical LLC Class II Ongoing Nationwide distribution: USA including states of: AZ, IL, KY, MD, MI, OH, OR, PA, TX and VA. Details
Devices Clinical Diagnostic Solutions Class III Ongoing Nationwide Distribution. Details
Devices Clinical Diagnostic Solutions Class III Ongoing Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV,and WY. Foreign: Brazil and Colombia Details
Devices Zimmer, Inc. Class II Ongoing Nationwide Distribution. Details
Food Fabrica Confecciones Soto, Inc. Class II Ongoing PR only. Product sold by the firm at retail. Details
Devices Diagnostica Stago, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and Canada Details
Devices Stryker Howmedica Osteonics Corp. Class II Ongoing Nationwide Distribution. Details
Food Fresh Express Incorporated Class I Ongoing AZ, CA, CO, ID, MD, MN, MT, OR, TX, WA and Canada. Details
Food FreshPoint Central Florida Class I Ongoing Florida Details
Devices Kerr Corporation Class II Completed Worldwide Distribution-USA (nationwide) and the countries of Canada, Europe, and Australia. Details
Devices Abbott Point Of Care Inc. Class III Ongoing Worldwide distribution: USA (nationwide) including states of: AZ, GA, ID, IL, LA, MD, MO, MN, NC, NV, OK, PA, TN, TX, VA and WI; and country of: Italy. Details
Food Kellogg Company Class II Ongoing US, nationwide and Canada Details
Food Jamba Juice Class I Ongoing Products were released for distribution in US. Details
Devices Sendx Medical Inc Class II Terminated Worldwide Distribution-- US Distribution including the state of Ohio and the countries of Switzerland, Germany, France, Poland, Austria, Italy, Japan, Australia, Denmark, China, Sweden, Norway, Spain, United Kingdom, Netherlands, and Czech Republic. Details
Devices Sunquest Information Systems, Inc. Class II Terminated Worldwide Distribution - USA (nationwide) and Internationally to Ireland Details
Devices Sunquest Information Systems, Inc. Class II Terminated Nationwide Distribution. Details
Devices Sorin Group USA, Inc. Class II Ongoing Worldwide distribution: USA (nationwide) including states of: AZ, GA, MI, MS, NC, NY, PA, SC, and TX; and countries of: Austria, Australia, Belgium, Canada, People's Republic of China, Columbia, Denmark, Finland, Germany, India, Iran-Islamic Republic of, Ireland, Japan, Lebanon, Morocco, Pakistan, Poland, Russian Federation, Saudia Arabia, Spain, South Africa, Thailand, Turkey and United Kingdom. Details
Devices OrthoPediatrics Corp Class II Ongoing Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA. Details
Food Clemmy's LLC Class I Ongoing US States: CA, WA, NC, DE, HI, MN, OH, NH, NY, and IL. No international distribution. Details
Food Belfonte Ice Cream & Dairy Foods Co Class I Ongoing The products were distributed in MO, KS, OK, AR Details
Devices Ormco/Sybronendo Class II Terminated Worldwide distribution, including Nationwide (USA) and the countries of Canada, Austria, Belgium, Bulgaria, Switzerland, Germany, Denmark, France, Estonia, Spain, Finland, Iceland, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Luxembourg, Netherlands, Monaco, Poland, Romania, Serbia, Slovenia, Turkey, Jersey, and Martinique. Details
Food Bliss Unlimited Class I Ongoing Product was distributed to California, Illinois, New Hampshire, New York, Washington, and Wisconsin. Details
Devices Philips Medical Systems (Cleveland), Inc. Class II Ongoing Nationwide distribution: USA including states of: ME, MI, NY, and WI. Details
Food Danielle Livolsi Jagrma Class I Ongoing CA & NH Details
Food PureFit Inc Class I Ongoing Nationwide in the US and worldwide: Australia, Canada, Norway, New Zealand, Ireland, Italy, and United Kingdom. Details
Food Flying Food Group, Inc. Class I Ongoing CT, MA, NY, NJ, PA, DE, MD, DC, VA, GA, FL, IL, WI, MN, IN, TX, AZ, NV, and CA Details
Food Hannaford Bros. Class I Terminated New York, Maine, New Hampshire, Massachusetts and Vermont Details
Food S & P Company Limited Class I Ongoing US states: AZ, CA, IL, NE, and TX. No international distribution. Details
Food Pennsylvania State University Berkey Creamery Class II Ongoing On site retail salesroom and internet customers Details
Food Mondelez Global Llc Class I Ongoing Nationwide. Details
Food Creative Energy Foods, Inc. LLC Class I Ongoing Product was only sold on the internet. Details
Food Velvet Ice Cream Company Class I Ongoing IN, KY, OH, and WV Details
Food Turkey Hill Dairy, Inc. Class II Ongoing Product was distributed to one retail chain and 3 independent grocers in the State of Pennsylvania. Details
Food Think Thin, LLC Class I Ongoing US states nationwide. No international distribution. Details
Food Dole Fresh Vegetables Inc Class I Ongoing IL, IN, ME,. MO, NJ, NY, OH, PA, TN and WI Details
Food Natural Selection Foods LLC dba Earthbound Farm Class I Ongoing CA, FL, HI, LA, MA, MT, NE, NJ, NY, OH, OR, PA, TX and Canada Details
Food Energy Club Inc Class I Ongoing nationwide in the US Details
Drugs Valeant Pharmaceuticals Class III Ongoing Nationwide Details
Food The Nut Factory Inc. Class I Ongoing Product was distributed in Washington state. There are no Canadian consignees. Details
Devices Spacelabs Healthcare, Llc Class II Ongoing Worldwide Distribution--US (nationwide) including states of Alaska, California, Florida, Illinois, Michigan, South Carolina, and Texas., and the countries of Canada, Chile, France, Libya, Panama, Qatar, Saudi Arabia, Switzerland and United Kingdom Details
Food Honolulu Baking Company, Ltd. Class I Terminated HI distribution only on island of Oahu. Details
Food Southern Belle, Inc. Class I Ongoing TN Details
Devices American Medical Systems, Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of Austria, Australia, Brazil, Canada, Germany, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Croatia, India, Morocco, Mexico, Malaysia, Netherlands, New Zealand, Panama, Poland, Russian Federation, Solomon Islands, Singapore, Thailand, Turkey, Venezuela, South Africa, Chile, Colombia, Costa Rica, Slovenia, Argentina, China, and Taiwan. Details
Food Williams and Company Inc dba The Nut Shop Class I Completed AL and MS Details
Devices Kimberly-Clark Corporation Class II Ongoing Nationwide Distribution Details
Devices Alphatec Spine, Inc. Class II Completed Nationwide Distribution including TN, WI, and FL. Details
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