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U.S. Department of Health and Human Services

Enforcement Report - Week of January 9, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Iowa; Illinois Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Missouri; Iowa; New York Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Biologics Community Blood Center Of Gtr KC Class III Terminated Kansas; Missouri Details
Biologics Community Blood Center Of Gtr KC Class III Terminated Missouri; Kansas; Iowa Details
Biologics ZLB Bioplasma, Inc. Class III Terminated Switzerland Details
Biologics American National Red Cross (The) Class II Terminated AR Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Devices Hill-Rom, Inc. Class II Ongoing Worldwide Distribution -- US (nationwide) including the states of AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MA, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OK, OR, PA, TN, TX, UT, WA, WV, and WY., and the country Canada, We have not yet defined our European or International facilities at this time. Details
Drugs Mylan LLC. Class II Ongoing Natiowide. Details
Drugs New England Compounding Center Class I,Class II Ongoing Nationwide Details
Biologics Blood Systems Inc/dba United Blood Services Class II Terminated Mississippi; Switzerland Details
Biologics LifeServe Blood Center Class II Terminated Iowa Details
Biologics Blood Bank Of Delmarva, Inc Class II Terminated Delaware Details
Biologics American National Red Cross The Class III Terminated California Details
Biologics Blood Centers of the Pacific - Irwin Center Class II Terminated California Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Missouri Details
Biologics Community Blood Centers of Florida, Inc. Class II Terminated Illinois; Florida Details
Biologics Southern California Permanente Medical Group Blood Donor Ctr Class II Terminated California Details
Biologics Sanford Medical Center (blood Bank) Class II Terminated Pennsylvania Details
Biologics Talecris Plasma Resources Class II Terminated North Carolina Details
Drugs Hospira Inc. Class II Ongoing Nationwide Details
Devices Stryker Medical Division of Stryker Corporation Class II Ongoing Worldwide Distribution - Nationwide and Canada Details
Devices Mindray DS USA, Inc. d.b.a. Mindray North America Class II Ongoing Nationwide Distribution including OH and GA Details
Food Fresh Express Incorporated Class I Ongoing AZ, CA, CO, HI, ID, KS, MO, MT, NE, NV, NM, OK, OR, SD, TX, UT, WA and WY. Details
Food Focus Products Group Llc Class II Ongoing Nationwide Details
Devices Cooper Vision Caribbean Corp. Class II Ongoing US Nationwide, including Puerto Rico, and Canada. Details
Devices Abbott Molecular Class II Ongoing Worldwide Distribution - USA (nationwide) and internationally to Algeria, Argentina, Australia, Austria, Azerbaijan, Belgium, Bolivia, Brazil, Burkina Faso, Burundi, Cameroon, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ethiopia, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Guinea, Haiti, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Mali, Mexico, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam and Zambia Details
Devices Medtronic Inc. Cardiac Rhythm Disease Management Class II Ongoing Worldwide Distribution--USA (nationwide) including the states of AZ, CA, CT, FL, GA, IL IA, MD, MA, MI, MS, NJ, NY, OH, OK, SC, TN, TX and WI. and the countries of CANADA and MALAYSIA. Details
Devices Hospira Inc. Class II Ongoing Worldwide Distribution -- USA, including Puerto Rico, and the countries of Austria, Australia, Argentina, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Finland, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates, and Vietnam. Details
Drugs Abbott Laboratories Class II Ongoing US Nationwide and Puerto Rico Details
Devices Fisher & Paykel Healthcare, Ltd. Class I Ongoing Worldwide Distribution - USA including IL, IN, AR and GA. Details
Food Cho Fuku Group (usa) Inc Class II Ongoing California and Washington Details
Food Gourmet Cuisine, Inc. Class I Ongoing TX only Details
Devices HemoCue AB Class III Ongoing Distributed in the states of FL, MA, CA, OR, NY, NC, MO, ID, IN, KY, PA, TX, OK, IL, GA, KS, and UT. Details
Food Natural Organics Class II Ongoing Nationwide and Puerto Rico Details
Devices Horiba Instruments, Inc dba Horiba Medical Class II Ongoing Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX. Details
Devices St Jude Medical Inc Class III Ongoing US Distribution only including the states of FL, KY and OK. Details
Devices B. Braun Medical, Inc. Class II Ongoing Worldwide Distribution--US (nationwide) including the states of AL, AZ, NC and TN. Details
Food Nature'S Path Foods Inc Class II Ongoing Distributed to CO, CA, CT, FL, GA, HI, IA, IN, NH, OR, PA, TX, and WA. Details
Devices Maquet Inc. Class II Ongoing Worldwide Distribution - USA including AR, GA, SC, TX, TN and internationally to France, United Arab Emirates, Australia, Brazil, Canada, Switzerland, China, Germany, Spain, United Kingdom, Italy, Japan, Sweden, Thailand, Turkey, Serbia, and South Africa. Details
Devices SynCardia Systems Inc. Class II Ongoing Worldwide Distribution -- US (nationwide) Details
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