Drug recall
Apheresis Platelets, Leukocytes Reduced
FDA recall event 83393 · Class II · BloodSource, Inc.
Key facts
| Event ID | 83393 |
|---|---|
| Recall numbers | B-0807-2019, B-0808-2019, B-0809-2019, B-0810-2019, B-0811-2019 |
| Recalling firm | BloodSource, Inc. |
| Product type | Biologics |
| Products | Apheresis Platelets, Leukocytes Reduced, Apheresis Red Blood Cells, Leukocytes Reduced, Platelets, Pathogen Reduced, Red Blood Cells, Leukocytes Reduced, Red Blood Cells, Leukocytes Reduced, Irradiated |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products collected from donors who traveled to a malarial endemic area, were distributed. |
| Initiation date | May 30, 2019 |
| Report date | Aug 21, 2019 |
| Termination date | Aug 13, 2019 |
| City | Mather |
| State | CA |
| Country | United States |
| FEI number | 3007101464 |
At a glance
- 1–9 Products in this recall
- 1–9 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: