Drug recall
Apheresis Red Blood Cells Adenine-Saline (AS-3) Added Irradiated Leukocytes Reduced (E4539V00, E4540V00)
FDA recall event 83033 · Class III · Bloodworks
Key facts
| Event ID | 83033 |
|---|---|
| Recall numbers | B-0731-2019 |
| Recalling firm | Bloodworks |
| Product type | Biologics |
| Products | Apheresis Red Blood Cells Adenine-Saline (AS-3) Added Irradiated Leukocytes Reduced (E4539V00, E4540V00) |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Unlicensed blood products were distributed in interstate commerce. |
| Initiation date | May 22, 2019 |
| Report date | Jul 3, 2019 |
| Termination date | Jun 27, 2019 |
| City | Seattle |
| State | WA |
| Country | United States |
| FEI number | 3071347 |
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: