Enforcement Report - Week of October 3, 2012
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| Product Type | Recalling Firm | Classification | Status | Distribution Pattern | Event Details |
|---|---|---|---|---|---|
| Biologics | ZLB Bioplasma, Inc. | Class II | Terminated | IL, IN, Germany, Switzerland | Details |
| Biologics | Community Blood Bank of Lancaster County Medical Society | Class II | Terminated | FL, Austria | Details |
| Biologics | Community Blood Center of Greater Kansas City | Class III | Terminated | Missouri | Details |
| Biologics | Community Blood Bank of Lancaster County Medical Society | Class II | Terminated | NE | Details |
| Biologics | Mary Greeley Medical Center | Class II | Terminated | IA, NY, MO | Details |
| Biologics | Community Blood Center of Greater Kansas City | Class III | Terminated | MO | Details |
| Biologics | Mercy Medical Center Blood Bank | Class II | Terminated | IA, | Details |
| Biologics | Community Blood Center of Greater Kansas City | Class II | Terminated | KS | Details |
| Biologics | Community Blood Center Of Gtr KC | Class III | Terminated | Kansas | Details |
| Biologics | Community Blood Center Of Gtr KC | Class III | Terminated | MO. | Details |
| Biologics | American National Red Cross (The) | Class III | Terminated | California | Details |
| Biologics | American National Red Cross (The) | Class II | Terminated | CO, NE, Switzerland | Details |
| Biologics | Mississippi Valley Reg Bld Ctr | Class III | Terminated | Iowa, Missouri, New York. | Details |
| Biologics | Community Blood Center Of Gtr KC | Class III | Terminated | Kansas. | Details |
| Biologics | Community Blood Bank of Lancaster County Medical Society | Class III | Terminated | Austria; FL; NE | Details |
| Biologics | Community Blood Bank of Lancaster County Medical Society | Class II,Class III | Terminated | NE; OH; TN; MO; Austria | Details |
| Biologics | American National Red Cross (The) | Class II,Class III | Terminated | NE | Details |
| Biologics | American Red Cross Blood Services | Class III | Terminated | unknown | Details |
| Biologics | Community Blood Bank of Lancaster County Medical Society | Class II,Class III | Terminated | MO; Austria | Details |
| Biologics | Mississippi Valley Regional Blood Center | Class II | Terminated | Iowa, Illinois | Details |
| Biologics | American National Red Cross (The) | Class II | Terminated | CA, MA | Details |
| Biologics | One Lambda Inc | Class II | Terminated | US States CA and NY. Nationwide to: Canada, United Kingdom, Germany, Israel, Spain, Japan, Singapore, and vietnam. | Details |
| Biologics | One Lambda Inc | Class II | Terminated | Nationwide in the US: OR and IL, and worldwide to Canada, Saudi Arabia/USA, United Kingdom, Germany, Italy, Jordon, Sweden, and Peru. | Details |
| Biologics | CSL Plasma, Inc. | Class II | Terminated | IL, Switzerland, Germany | Details |
| Biologics | Octapharma Plasma, Inc. | Class III | Terminated | CA, Austria | Details |
| Biologics | BloodSource, Inc. | Class II | Terminated | CA, Austria | Details |
| Biologics | Delta Blood Bank | Class II | Terminated | CA. | Details |
| Biologics | Delta Blood Bank | Class III | Terminated | IN. | Details |
| Biologics | Delta Blood Bank | Class II | Terminated | CA. | Details |
| Food/Cosmetics | McClures, Inc. | Class I,Class II | Ongoing | Product was distributed to retail outlets in DE, MD, NJ and PA within the US. | Details |
| Drugs | www.vitaminbestbuy.com | Class I | Ongoing | Nationwide | Details |
| Biologics | Blood Centers of the Pacific - Irwin Center | Class II | Terminated | Switzerland; Austria; Armed Forces Americas, California | Details |
| Biologics | Walter L. Shepeard Community Blood Center, Inc. | Class II | Terminated | Georgia | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide and US Nationwide Distribution | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and the countries of AUSTRALIA, Singapore, Jordan, Japan, Vietnam, Germany, Russia, Saudi Arabia, BELGIUM, Mexico, and CANADA. | Details |
| Drugs | Watson Laboratories, Inc. | Class II | Ongoing | Nationwide | Details |
| Devices | Alcon Research, LTD. | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Greece, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria. | Details |
| Drugs | Ben Venue Laboratories Inc | Class I | Ongoing | Nationwide | Details |
| Devices | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | Class III | Ongoing | Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX. | Details |
| Food/Cosmetics | Haldeman Mills | Class II | Ongoing | Product was distributed to specific wholesale and retail outlets within the State of Pennsylvania | Details |
| Devices | OPTI Medical Systems, Inc | Class II | Ongoing | Worldwide Distribution -- US (nationwide) including the states of AZ, ID, TX and UT., and the countries of Argentina, Bolivia, China, Ecuador, France, Germany Greece, India, Indonesia, Iran, Ireland, Japan, Kuwait, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Nigeria, Poland, Romania, Russia, Saudi Arabia, Singapore, South Africa, Sudan Switzerland, Turkey, United kingdom, Venezuela, and Viet Nam. | Details |
| Drugs | Abbott Laboratories | Class II | Ongoing | Nationwide | Details |
| Drugs | Mallinckrodt Inc | Class III | Ongoing | AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK | Details |
| Food/Cosmetics | Derby City Vending Inc | Class I,Class II | Ongoing | Product was shipped to KY and IN. | Details |
| Devices | Imaging Sciences International, LLC | Class II | Ongoing | Worldwide Distribution - USA including Washington, DC, AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and the country of Canada. | Details |
| Drugs | Bracco Diagnostics Inc | Class II | Ongoing | Nationwide and United Kingdom | Details |
| Drugs | Mylan Pharmaceuticals Inc. | Class II | Completed | The product was distributed to KY. | Details |
| Food/Cosmetics | Triton Seafood Co. | Class II | Terminated | Product was distributed throughout the state of Florida and Texas. | Details |
| Devices | Cordis Corporation | Class II | Completed | Worldwide Distribution - USA and Germany | Details |
| Devices | Mc-NEIL-PPC, Inc. | Class II | Ongoing | Nationwide Distribution | Details |
| Devices | Invacare Corporation | Class II | Ongoing | Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of AUSTRALIA, CANADA, GUAM, ISRAEL, NEW ZEALAND, THAILAND, TRINIDAD AND TOBAGO. | Details |
| Devices | KCI USA, Inc. | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria. | Details |
| Food/Cosmetics | Pulmuone Wildwood Inc | Class II | Ongoing | Nationwide and Canada. | Details |
| Food/Cosmetics | MyoSci Technologies Inc. | Class I | Ongoing | nationwide in the US and worldwide to Canada and United Kingdom. | Details |
| Devices | Linvatec Corp. dba ConMed Linvatec | Class II | Terminated | Worldwide Distribution - US Nationwide and the countries of Canada, DK, HK, IN, IT, KR, MY, RU, CO, VN, ZA. | Details |
| Food/Cosmetics | Cucina Fresca, Inc. | Class I | Ongoing | Product was distributed to Oregon and Washington | Details |
| Devices | Covidien LP | Class II | Ongoing | Worldwide Distribution. | Details |
| Biologics | Rocky Mountain Lions Eye Bank | Class II | Terminated | Japan | Details |
| Biologics | Lions Eye Bank of Texas | Class II | Terminated | Texas | Details |
| Biologics | Upstate New York Transplant Services | Class II | Terminated | New York | Details |
| Biologics | RTI Biologics, Inc. | Class II | Terminated | Oklahoma | Details |
| Biologics | RTI Biologics, Inc. | Class II | Terminated | Arizona; Pennsylvania; South Carolina; Oregon; Maryland; California; Florida | Details |
| Food/Cosmetics | Splendid Products | Class I | Ongoing | Nationwide distribution. | Details |
| Devices | Philips Medical Systems (Cleveland) Inc | Class II | Ongoing | Worldwide Distribution - USA including AL, AZ, CA, CO, FL, GA, IL, KS, KY, MI, MS, NJ, NM, NV, NY, OH, TX, WA & WI and internationally to: Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, India, Italy, Japan, Jordan, Mexico, Saudi Arabia, South Korea, Spain, Thailand, Turkey & United Kingdom. | Details |
| Food/Cosmetics | Meijer Distribution, Inc | Class II | Ongoing | Up to 199 Meijer stores located in Illinois, Indiana, Kentucky, Michigan, and Ohio may have received product from Meijer distribution centers. | Details |
| Biologics | Viacord Processing Laboratory | Class II | Terminated | New York | Details |
| Biologics | Lions Eye Institute for Transplant & Research, Inc. | Class II | Terminated | California; Florida | Details |
| Food/Cosmetics | Gordon Food Service | Class I | Ongoing | restaurants and GFS retail outlets in Florida | Details |
| Food/Cosmetics | Indalco Foods Corp. | Class I | Ongoing | US | Details |
| Food/Cosmetics | Ready Pac Foods Inc | Class I | Ongoing | Nationwide to following US States and Canada: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Washington D.C., Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, Wyoming, and Canada. | Details |
| Devices | Alere San Diego, Inc. | Class II | Ongoing | Nationwide Distribution. | Details |
| Devices | Abbott Vascular | Class II | Ongoing | Nationwide(US) Distribution and Puerto Rico. | Details |
| Devices | Varian Medical Systems, Inc. Oncology Systems | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and Internationally. . . | Details |
| Drugs | Dispensing Solutions, Inc | Class II | Ongoing | US: IN & WI | Details |
| Devices | Applied Medical Resources Corp | Class II | Ongoing | Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa. | Details |
| Devices | Linvatec Corp. dba ConMed Linvatec | Class II | Ongoing | Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA ,WI and Hawaii., and the countries of Australia Canada, China, Switzerland, Germany, Czech Republic, Denmark, Egypt, Spain, France, South Africa, United Kingdom, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Russia and Saudi Arabia. | Details |
| Devices | Philips Healthcare Inc. | Class II | Ongoing | Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, Chile, Finland, France, Germany, Hungary. Italy, Japan, Latvia, Netherlands, New Zealand. Oman, South Korea, Switzerland and United Kingdom. | Details |
| Devices | Greatbatch Medical | Class II | Ongoing | Distributed in MA. | Details |
| Food/Cosmetics | M & K Trading Inc | Class II | Terminated | California | Details |
| Food/Cosmetics | Dawn Food Products, Incorporated | Class I | Ongoing | To Sam's Club locations in UT, OK, TX CA, MO, and WY, USA. | Details |
| Devices | Neomend Inc | Class II | Terminated | US Nationwide Distribution | Details |
| Devices | Toshiba American Medical Systems Inc | Class II | Terminated | Nationwide distribution: USA including states of: MA, MD, and NV. | Details |
| Devices | Hologic, Inc. | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia,Belgium, Canada, China, Germany, Ecuador, Spain, France, Great Britain, Greece, Hong Kong, Italy, Japan Korea, Lithuvania, Neherlands, qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan, South Africa, and Switzerland. | Details |
| Devices | RAYSEARCH LABORATORIES AB | Class II | Completed | Worldwide Distribution - USA including CA, KY, MI, NY, OK, OR, SD, and WI. Internationalyl to Canada, Sweden, France, Germany, Australia, Poland, Belgium, and United Kingdom. | Details |
| Devices | Micro Therapeutics Inc, Dba Ev3 Neurovascular | Class II | Completed | Worldwide Distribution - US Nationwide including the states: MN, FL, OR, TX and the countries of: Brazil, Belgium, Czech Republic, Finlind, France, Germany, Netherlands, Poland, and United Kingdom. | Details |
| Drugs | Baxter Healthcare Corp. | Class II | Ongoing | Nationwide and Puerto Rico | Details |
| Devices | Siemens Medical Solutions USA, Inc | Class II | Ongoing | Nationwide Distribution - USA including Washington, DC and AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI and Puerto Rico. | Details |
| Drugs | Hospira Inc. | Class II | Ongoing | Nationwide | Details |
| Drugs | Glenmark Generics Inc., USA | Class II | Ongoing | Nationwide | Details |
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