Drug recall
Apheresis Red Blood Cells, Leukocytes Reduced
FDA recall event 84175 · Class II · OneBlood, Inc.
Key facts
| Event ID | 84175 |
|---|---|
| Recall numbers | B-0114-2020 |
| Recalling firm | OneBlood, Inc. |
| Product type | Biologics |
| Products | Apheresis Red Blood Cells, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Apheresis Red Blood Cells, Leukoreduced, collected in a manner that compromised the sterility of the collection system, were distributed. |
| Initiation date | Oct 25, 2019 |
| Report date | Nov 27, 2019 |
| Termination date | Nov 15, 2019 |
| City | St Petersburg |
| State | FL |
| Country | United States |
| FEI number | 1070196 |
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: