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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Illinois Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Illinois; Iowa; Switzerland Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Biologics BioLife Plasma Services L.P. Class III Terminated CA Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Biologics CSL Plasma, Inc. Class II Terminated Illinois; Germany; Switzerland Details
Biologics CSL Plasma, Inc. Class II Terminated Illinois; North Carolina; Germany; Switzerland Details
Devices First Medical Source LLC Class I Terminated US Nationwide distribution in the state of IL Details
Food Quality Dairy Farms Inc. Class II Terminated Upstate New York Details
Devices Extremity Medical LLC Class II Ongoing Worldwide Distribution - USA including FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE. Internationally to Switzerland. Details
Biologics Florida Blood Services, Inc. Class III Terminated Florida Details
Biologics BloodSource, Inc. Class II Terminated California Details
Biologics LifeShare Blood Centers Class III Terminated Switzerland 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 New York Blood Center, Inc. Class II Terminated New York Details
Biologics Belle Bonfils Memorial Blood Center Class II Terminated Pennsylvania; Colorado Details
Drugs Samantha Lynn, Inc Class I Ongoing Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan 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 Michigan Blood Class II Terminated Michigan Details
Devices GE Healthcare, LLC Class II Ongoing Nationwide distribution Details
Devices Parks Medical Electronics, Inc Class II Ongoing Worldwide distribution: USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, Egypt, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Mexico, Peru, Republica Argentina, Spain, Switzerland, and Venezuela. Details
Devices Diamedix Corporation Class II Ongoing Worldwide Distribution - USA Nationwide including the states: CA, ID, NJ, NY, OH, PA, PR, RI, TN, and TX, FL, and the countries of Italy, Chile and Ecuador Details
Food Nestle Professional Class II Ongoing Distributed to CA. Details
Food Gasco Industrial Class II Ongoing PR only Details
Food BumbleBar, Inc. Class I Ongoing Products are distributed nationwide and Hong Kong Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV. Details
Devices Zimmer, Inc. Class II Ongoing Worldwide Distribution - USA including AZ,CA, FL, IA, IL, IN, MO, NE, NJ, NY, OH, PA, WA. Internationally to Thailand, Canada, Germany, France, UK, Hungary, Netherlands, Russian Fed, and Sweden, Details
Devices Metrex Research, LLC. Class II Terminated Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe. Details
Food Wm Bolthouse Farms Inc Class I Ongoing US and Canada Details
Food CSM Bakery Products NA Class I Ongoing New York, New Jersey, Massachusetts, Illinois, Ohio, and Ontario, Canada Details
Drugs Boehringer Ingelheim Roxane Inc Class II Ongoing Nationwide Details
Devices Kimberly-Clark Corporation Class II Completed Nationwide Distribution including AZ, AK, CA, CO, DE, DC, FL, GA. ID, IL, IN, IA, KS, KY, LA, MD, ME MA, MS, MO, MT, NE, NJ, NM, NV, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WV, and WI Details
Drugs Procter & Gamble Co Class II Ongoing Nationwide Details
Food Hillshire Brands Company Class I Ongoing Iowa, Maine, Maryland, Michigan, Minnesota, Missouri, New York, Ohio, Pennsylvania and Virginia Details
Food Nestle USA Class I Ongoing Nationwide in the US Details
Food Kroger Co Class I Ongoing Product was shipped to the following states: AZ, CO, ID, KS, MO, MT, NE, NM, NV,UT & WY. Details
Devices Iradimed Corporation Class II Ongoing Nationwide Distribution including AZ, CA, FL, KY, MD, MA, NJ, NY, PA, and TX. Details
Devices Cooper Surgical, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Czech Republic, Germany, Italy, Spain, France, United Kingdom, Japan, New Zealand, South Korea, Saudi Arabia, Sweden, Singapore, Slovenia, and Taiwan. Details
Drugs GlaxoSmithKline, LLC. Class II Ongoing Nationwide Details
Food Tri-Union Seafoods, L.L.C dba Chicken of the Sea. Class I Ongoing Nationwide in the US: TX, IL, UT, WA, CA, AZ. Details
Drugs GlaxoSmithKline, LLC. Class III Ongoing Nationwide and Puerto Rico. Details
Devices Biomet, Inc. Class II Ongoing Nationwide distribution: USA including states of: AZ, MD, and KS. Details
Food Ernimich, Inc. (dba Nina International, Inc.) Class I Ongoing The products were sold in Virginia, Maryland and Washington, D.C. Details
Devices Medtronic Navigation, Inc. Class II Ongoing Worldwide Distribution--US (nationwide) including the states of CA, FL, MA, LA, and MI and the countries of Switzerland, Saudi Arabia, Lebanon, Canada and Korea. Details
Food Whole Foods Market South Seafood Distribution Class I Ongoing AL, GA, NC, SC and TN. Details
Food United Dairy Farmers Inc Class I Ongoing Ohio, Inidania, Kentucky, and Michigan Details
Drugs Ranbaxy Inc. Class II Ongoing Nationwide and PR Details
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