Enforcement Report - Week of January 9, 2013
-
| 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | Cho Fuku Group (usa) Inc | Class II | Ongoing | California and Washington | Details |
| Food/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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 |
-
