Drug recall
Cardiac Tissue, Non-valved
FDA recall event 65437 · Class II · LifeNet Health
Key facts
| Event ID | 65437 |
|---|---|
| Recall numbers | B-2097-13 |
| Recalling firm | LifeNet Health |
| Product type | Biologics |
| Products | Cardiac Tissue, Non-valved |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Cardiac pulmonary patch, recovered from a donor and not tested using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to… |
| Initiation date | May 10, 2013 |
| Report date | Jul 17, 2013 |
| Termination date | Jul 8, 2013 |
| City | Virginia Beach |
| State | VA |
| Country | United States |
| FEI number | 3005064037 |
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: