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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | Unified Grocers Inc. | Class III | Ongoing | Nationwide in the US: CA, AK, WA, and OR. | Details |
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