Drug recall
Platelets Pheresis Leukocytes Reduced
FDA recall event 71353 · Class III · American National Red Cross (the)
Key facts
| Event ID | 71353 |
|---|---|
| Recall numbers | B-0708-15, B-0709-15 |
| Recalling firm | American National Red Cross (the) |
| Product type | Biologics |
| Products | Platelets Pheresis Leukocytes Reduced, Platelets Pheresis Leukocytes Reduced Irradiated |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Platelet products, collected on an instrument that failed the leukoreduction quality control process, were distributed. |
| Initiation date | Apr 7, 2015 |
| Report date | Jul 1, 2015 |
| Termination date | Jun 19, 2015 |
| City | West Henrietta |
| State | NY |
| Country | United States |
| FEI number | 3002957282 |
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: