Drug recall
Fresh Frozen Plasma
FDA recall event 28086 · Class II · Inova Health System/Blood Donor Services
Key facts
| Event ID | 28086 |
|---|---|
| Recall numbers | B-0727-4, B-0728-4 |
| Recalling firm | Inova Health System/Blood Donor Services |
| Product type | Biologics |
| Products | Fresh Frozen Plasma, Red Blood Cells, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, collected from a donor who tested negative for anti-HIV - 1/2, but previously tested positive for anti-HIV, were distributed. |
| Initiation date | Nov 19, 2003 |
| Termination date | Mar 8, 2004 |
| City | Annandale |
| Country | United States |
| FEI number | 1177788 |
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