Drug recall
Fresh Frozen Plasma
FDA recall event 67181 · Class II · OneBlood, Inc.
Key facts
| Event ID | 67181 |
|---|---|
| Recall numbers | B-0353-14, B-0354-14, B-0355-14, B-0356-14 |
| Recalling firm | OneBlood, Inc. |
| Product type | Biologics |
| Products | Fresh Frozen Plasma, Platelets Pooled Leukocytes Reduced, Red Blood Cells, Red Blood Cells (Apheresis) Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. |
| Initiation date | Nov 12, 2013 |
| Report date | Feb 12, 2014 |
| Termination date | Feb 5, 2014 |
| City | Lauderhill |
| State | FL |
| Country | United States |
| FEI number | 1077496 |
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: