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U.S. Department of Health and Human Services

Enforcement Report - Week of December 19, 2012

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Missouri; Pennsylvania Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Biologics American National Red Cross (The) Class II,Class III Terminated AR, CA Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated NC Details
Biologics CSL Plasma, Inc. Class II Terminated Illinois, Indiana, Switzerland, Germany Details
Biologics CSL Plasma, Inc. Class II Terminated Illinois; Germany; Switzerland Details
Biologics CSL Plasma, Inc. Class II Terminated Illinois Details
Biologics CSL Plasma, Inc. Class II Terminated Illinois, North Carolina, Switzerland, Germany, Details
Biologics CSL Plasma, Inc. Class II Terminated Illinois; Germany; Switzerland Details
Biologics LifeShare Blood Centers Class II Terminated Texas Details
Food Baugher Enterprises, Incorporated Class I Completed The product was sold to a distributor in MD and retailers in MD and the Gettysburg, PA area. Details
Biologics American National Red Cross (The) Class II Terminated CA, AZ, ID, TN, MI, UT Details
Devices Covidien LLC dba Uni-Patch Class II Completed Nationwide Distribution including CA, IL, MA, MN, and SD. Details
Veterinary PECO Foods Inc. Class III Completed Arkansas Details
Drugs Physicians Total Care, Inc. Class III Completed VA Details
Biologics ONEBLOOD Inc DBA: Southeastern Comm. Blood Center Class II Terminated Florida Details
Biologics American National Red Cross, Penn-Jersey Region Class II,Class III Terminated Pennsylvania; California Details
Biologics Puget Sound Blood Center and Program Class II Terminated Washington Details
Biologics American National Red Cross The Class II Terminated California Details
Biologics Department Of The Army Class II Terminated Washington; New York Details
Devices Roche Molecular Systems, Inc. Class II Ongoing Nationwide Distribution Details
Biologics American National Red Cross, The Class III Terminated West Virginia 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 Biomat USA, Inc. Class II Terminated Spain Details
Biologics Biomat USA, Inc. Class II Terminated California Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated Alabama Details
Food Lin-Mar Partners Inc Class I Ongoing TX only Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing Nationwide Distribution Details
Devices Hospira Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) including Puerto Rico, and the countries of Australia, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Lavenia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates and Vietnam. Details
Devices Quasar Bio-Tech, Inc. dba Silver Bay LLC Class II Ongoing Worldwide distribution: USA (nationwide) including states of: AZ, CA, CO, FL, GA, HI, ID, IL, KS, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OR, TN, TX, UT, VA, and WA; and countries of: Aruba, Canada, Cayman Islands, China, Estonia, Ireland, Malaysia, New Zealand, Singapore, Sweden, Taiwan, and United Kingdom. Details
Food Costco Wholesale Class II Ongoing Product was distributed in Costco Warehouse stores throughout the United States Details
Devices Mindray DS USA, Inc. d.b.a. Mindray North America Class II Ongoing Nationwide Distribution-USA (nationwide) including the states of WA, IL, FL, MN, SC, NV, MI, TN, PA, LA, NE, TX, and IA. Details
Food Ella's Kitchen Class III Ongoing Nationwide Details
Devices Verathon, Inc. Class I Ongoing Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NM, NV, NJ, NY, OK, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and countries of: Argentina, Australia, Canada, China, France, Germany, Indonesia, Japan, The Netherlands, Pakistan, Panama, Peru, Philippines, Singapore, South Korea, Taiwan, Thailand, United Kingdom, and Venezuela. Details
Devices Roche Diagnostics Operations, Inc. Class II Ongoing Nationwide Distribution including NE and AZ. Details
Devices Siemens Healthcare Diagnostics, Inc Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally to the following countries: Argentina Australia Austria Azerbaijan Belgium Bosnia Herzeg. Brazil Canada Chile COLOMBIA Croatia Czech Republic Denmark Egypt Estonia Finland France Germany Greece Hong Kong Hungary Iceland India Indonesia Iran Ireland Italy Japan Kazakhstan Latvia Lithuania Malaysia Mexico Netherlands New Caledonia Norway Oman P.R. China Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Reunion Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. United Kingdom Uruguay Vietnam Details
Food Turkana Food Inc. Class I Ongoing Northeast Details
Devices Leica Microsystems, Inc. Class II Ongoing Worldwide Distribution -- USA including Arkansas, California, Florida, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, Oregon, Rhode Island, Tennessee, Texas and Wisconsin, and the country of Canada. Details
Food Berres Brothers, Inc. Class I Ongoing AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, MD, MI, MN, MS,MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SC,SD, TN, TX, VA, WA, AW, WI, WY. OUS: GU, AE, CA Details
Devices Philips Healthcare Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and Canada. Details
Devices Medtronic Neuromodulation Class I Ongoing Worldwide distribution: USA (nationwide) and countries including: Canada and Mexico. Details
Devices Becton Dickinson & Co. Class II Ongoing Worldwide Distribution - USA (nationwide) to international customers in Belgium, India, Japan, South Korea, Thailand and Mexico Details
Devices ConMed Corporation Class II Ongoing Worldwide Distribution - USA including CA , FL, IA, IN, MA, MD, ME, MO, MS, NC, NM, OH, PA, TX. Foreign distribution to Spain, Portugal, Japan and Hungary. Details
Devices Advanced Sterilization Products Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of AR, AU, BE, BR, CA, CL, CN, CO, EC, GT, HK, ID, IN, JP, KR, MX, MY, PA, PE, PH, SG, TH, VE, and RU. Details
Food Unified Grocers Inc. Class III Ongoing Nationwide in the US: CA, AK, WA, and OR. Details
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