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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics American Red Cross Blood Services Class II Terminated NB Details
Biologics Community Blood Center of the Ozarks Class II Terminated FL; MO; NJ; AR; Austria Details
Biologics American Red Cross Blood Services Class II Terminated NE,CA Details
Biologics American Red Cross Blood Services Class III Terminated NE Details
Biologics American Red Cross Blood Services Class II Terminated PA, NJ Details
Biologics Northwest Florida Blood Center, Inc. Class III Terminated FL Details
Biologics Community Blood Center of the Ozarks Class III Terminated MO; AR; NJ Details
Biologics American National Red Cross (The) Class II Terminated NE; MA Details
Biologics Florida Georgia Blood Alliance, Inc. Class II Terminated FL and SC Details
Biologics Hoxworth Blood Center University of Cincinnati Medical Center Class II Terminated OH Details
Biologics Northwest Florida Blood Center, Inc. Class II Terminated AL Details
Biologics Florida Georgia Blood Alliance, Inc. Class III Terminated FL Details
Biologics The Blood Alliance, Inc. Class II Terminated FL Details
Biologics Lane Memorial Blood Bank Class II Terminated TN Details
Biologics Hoxworth Blood Center University of Cincinnati Medical Center Class II Terminated OH Details
Biologics The Blood Alliance, Inc. Class III Terminated FL Details
Biologics The Blood Alliance, Inc. Class II Terminated FL Details
Biologics Northwest Florida Blood Center, Inc. Class II Terminated FL, AL Details
Biologics American National Red Cross (The) Class II Terminated NY Details
Biologics Florida's Blood Centers, Inc. Class II Terminated FL Details
Biologics Florida Blood Services, Inc. Class II Terminated AL Details
Biologics American National Red Cross (The) Class II Terminated PA Details
Biologics American National Red Cross (The) Class II,Class III Terminated NY Details
Biologics The Blood Alliance, Inc. Class II Terminated FL Details
Biologics American National Red Cross (The) Class III Terminated PA and NY Details
Biologics Talecris Plasma Resources, Inc. Class III Terminated NC Details
Biologics The Blood Alliance, Inc. Class II Terminated FL, MO Details
Biologics American National Red Cross (The) Class III Terminated NY Details
Biologics The Blood Alliance, Inc. Class II Terminated FL Details
Biologics Talecris Plasma Resources, Inc. Class III Terminated NC Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Biologics BioLife Plasma Services L.P. Class III Terminated CA Details
Food Good Source Incorporated Class II Ongoing IL, NE, RI, WY, CA, NV Details
Biologics United States Blood Bank, Inc. Class II Terminated TX Details
Food Alymaq Inc Class III Ongoing Ohio Details
Biologics South Texas Blood & Tissue Center Class II Terminated FL; TX Details
Devices Merit Medical Systems, Inc. Class II Completed Germany Details
Biologics Hoxworth Blood Center UC Medical Center Class II Terminated OH Details
Biologics Blood Systems, Inc Class II Terminated NM Details
Biologics Blood Assurance Inc Class II,Class III Terminated TN, NY Details
Biologics Talecris Plasma Resources Inc Class III Terminated North Carolina Details
Drugs Clinical Specialties Compounding Pharmacy Class II Ongoing FL, GA and SC. Details
Biologics The Blood Connection, Inc. Class II Terminated TN; SC; NC; NY Details
Biologics Inland Northwest Blood Center Class II Terminated ID Details
Biologics The Blood Connection, Inc. Class II Terminated SC Details
Biologics Medic Inc Class II Terminated TN Details
Devices Clorox Healthcare Holdings, LLC (dba HealthLink) Class II Ongoing Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AZ, CA, CO, FL, GA, IA, IL, IN, MI, MO, MS, MT, NC, NJ, NY, OH, SC,TX ,VA ,WA, WI, and HI, and the countries of Canada, Mexico, and New Zealand. Details
Biologics Penrose-St Francis Health Services Blood Bank Class II Terminated CO Details
Biologics Penrose-St Francis Health Services Blood Bank Class II Terminated CO Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated GA Details
Biologics American National Red Cross (the) Class II Terminated NC Details
Biologics American National Red Cross Class III Terminated OH Details
Biologics South Bend Medical Foundation, Inc. Class II Terminated IN Details
Devices The Anspach Effort, Inc. Class II Ongoing Worldwide Distribution - USA Nationwide including the states of: AZ, CA, FL, KY, ME, MI, MO, OH, PA, TN, TX , VA, and the countries of: Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey; Details
Devices GE Healthcare, LLC Class II Completed Worldwide distribution - USA including AZ, CA, CO, FL, ID, IL, ME, NV,NY, NC, OK, TN, UT, and WI; and Internationally to Canada, Chile, France, Germany, Italy, Japan, Korea, Norway and Spain. Details
Food Green Mountain Coffee Roasters Class II Ongoing TX, LA, MD, IN, IL, NE, NC, MN, WI, FL, AL Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing USA Nationwide Distribution - including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Details
Food Delhaize America (Hannaford Bros) Class I Completed Maine, New Hampshire, Vermont, New York and Massachusetts. Details
Devices Maquet Cardiovascular Us Sales, Llc Class II Ongoing Worldwide Distribution - USA including Arizona, Georgia, North Dakota, South Carolina, Texas and Tennessee, Internationally to United Arab Emirates, Austria, Brazil, Canada, Switzerland, China, Germany, Spain, France, United Kingdom, Italy, Japan, Singapore, Thailand, Turkey, Serbia, and South Africa. Details
Devices Linvatec Corp. dba ConMed Linvatec Class II Ongoing US Distribution including the states of FL, KY, LA, MI, NC, and NY. Details
Veterinary Wedgewood Village Pharmacy, Inc. Class II Ongoing Nationwide Details
Devices Bard Access Systems Class II Ongoing National and Global distribution (Europe, European Economic Area, Argentina, China, and Brazil). Details
Devices Surgical Instrument Service And Savings, Inc. Class II Ongoing Nationwide Distribution. Details
Devices Ortho-Clinical Diagnostics Class II Ongoing Worldwide Distribution - USA Nationwide including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI & WV, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain Details
Food Florida Nutri Labs, LLC Class II Ongoing Product was distributed to 1 distributor, Kirland Science Labs located in Seattle, WA. Details
Devices Penlon, Ltd. Class II Ongoing Worldwide Distribution - USA including FL, KY, PA, ND, MN, IL, NJ, TX, TN, and VA. Internationally to Belgium, China, Czech Republic, France, Germany, Switzerland, Australia, Finland, Holland, Lithunia, Malta, Poland, and Slovakia. Details
Drugs Baxter Healthcare Corp. Class II Ongoing Nationwide & Puerto Rico Details
Devices Zimmer, Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of NY, MI, MN, OH, IN, IL, VA, MD, PA, WA, KY, CT, RI, NH, TX, MT, and CA and the countries of Chile, China, South Korea, and Australia. Details
Food Food Concepts Class II Ongoing SC Details
Food ABCO Laboratories, Inc. Class II Ongoing CA and PA. Details
Food General Mills, Inc Class I Ongoing The recall involved 2 customers with 6 shipping locations. WV, SC, VA, GA, TN. Details
Food Cheryls Class II Ongoing The product has been distibuted to 13 military members in Europe and the Pacific regions, as well as customers in these states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY. Details
Drugs Pfizer Inc. Class III Ongoing Nationwide and Puerto Rico Details
Devices BRAEMAR, INC. Class II Ongoing Nationwide Distribution including FL, IL, LMD, MA, MN, NY, OH, PA, TN, and TX. Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing Worldwide Distribution: USA Nationwide and countries of: Algeria, Angola, Argentina, Austria, Australia, Bahamas, Belgium, Bosnia Herzeg, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Ecuador, Egypt, El Salvador, France, Germany, Greece, Hungary, India, Indonesia, Italy, Iran, Iraq, Ireland, Japan, Jordan, Kenya, DPR of Korea, Kosovo, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Pakistan, Palestinian Ter, Peru, Philippines, P.R. China, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sri Lanka, South Africa, Sweden, Switzerlan, Taiwan, Thailand, Trinidad Tobago,Turkey, United Kingdom, Venezula, Vietnam, Rep of Yemen, and Zambia. Details
Devices BRAEMAR, INC. Class II Ongoing Nationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, TN, and TX. Details
Food Butterfly Bakery Inc. Class I Ongoing NY Details
Devices Becton Dickinson & Co. Class III Ongoing Worldwide Distribution - USA Nationwide and in the countries of: Japan, Singapore, Hong Kong, China, Australia, Europe, and Chile. Details
Food Hoover Mill, Inc. Class II Terminated Alabama Details
Food Middlefield Original Cheese Coop Class II Ongoing The cheese was sold/distributed to Laubscher Cheese 1468 Perry Highway Mercer, PA 16137, contact is Kevin at 800-798-4015; the liquid whey was sold/distributed to Miceli's Cheese 2721 E. 90th St Cleveland, Ohio 44104, contact is Cominick at 800-551-7196 Ext. 125. Details
Devices DJO, LLC Class II Ongoing Worldwide Distribution - USA Nationwide and countries of: Australia, Belgium, China, Guatemala CentroAmeria, France, Hong Kong, India,Italy, Korea, Lebanon, Malaysia, Morocco, Pakistan, Paraguay, The Netherlands, Romania, Singapore, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom and Venezula, Details
Devices Biosense Webster, Inc. Class II Ongoing Distributed in the states of MN, FL, and UT. Details
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