Drug recall
Blood and Blood Products for Reprocessing
FDA recall event 77748 · Class II, Class III · HCSC-Blood Center dba as Miller-Keystone Blood Center
Key facts
| Event ID | 77748 |
|---|---|
| Recall numbers | B-0821-2017, B-0822-2017, B-0823-2017, B-0824-2017 |
| Recalling firm | HCSC-Blood Center dba as Miller-Keystone Blood Center |
| Product type | Biologics |
| Products | Blood and Blood Products for Reprocessing, Plasma Frozen within 24 hours (FP24), Pooled Cryoprecipitated AHF, Red Blood Cells, Leukocytes Reduced |
| Classification | Class II, Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. |
| Initiation date | Feb 16, 2017 |
| Report date | Aug 30, 2017 |
| Termination date | Aug 23, 2017 |
| City | Bethlehem |
| State | PA |
| Country | United States |
| FEI number | 2573135 |
At a glance
- 1–9 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: