Drug recall
Pooled Platelets, Leukocytes Reduced
FDA recall event 83309 · Class II · Walter L. Shepeard Community Blood Center, Inc.
Key facts
| Event ID | 83309 |
|---|---|
| Recall numbers | B-0761-2019 |
| Recalling firm | Walter L. Shepeard Community Blood Center, Inc. |
| Product type | Biologics |
| Products | Pooled Platelets, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Leukoreduced Pooled Platelets, in which platelet yield did not meet product specifications, was distributed. |
| Initiation date | Jul 3, 2019 |
| Report date | Aug 7, 2019 |
| Termination date | Aug 1, 2019 |
| City | Augusta |
| State | GA |
| Country | United States |
| FEI number | 1046616 |
At a glance
- 1–9 Products in this recall
- None 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: