Drug recall
Apheresis Fresh Frozen Plasma
FDA recall event 76398 · Class III · Carter BloodCare
Key facts
| Event ID | 76398 |
|---|---|
| Recall numbers | B-0343-2017, B-0344-2017, B-0345-2017, B-0346-2017, B-0347-2017, B-0348-2017, B-0349-2017, B-0350-2017, B-0351-2017, B-0352-2017 |
| Recalling firm | Carter BloodCare |
| Product type | Biologics |
| Products | Apheresis Fresh Frozen Plasma, Apheresis Platelets, Leukocytes Reduced, Apheresis Red Blood Cells, Leukocytes Reduced, Cryoprecipitated AHF, Fresh Frozen Plasma and 5 more |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, collected from ineligible donors based on testing for relevant transfusion transmitted infection testing, were distributed. |
| Initiation date | Jan 24, 2017 |
| Report date | Feb 22, 2017 |
| Termination date | Feb 10, 2017 |
| City | Bedford |
| State | TX |
| Country | United States |
| FEI number | 3002603147 |
At a glance
- 10–99 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: