Drug recall
Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of…
FDA recall event 92090 · Class II · TELEFLEX LLC
Key facts
| Event ID | 92090 |
|---|---|
| Recall numbers | Z-1611-2023 |
| Recalling firm | TELEFLEX LLC |
| Product type | Devices |
| Products | Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product. |
| Initiation date | Apr 12, 2023 |
| Report date | May 24, 2023 |
| City | Morrisville |
| State | NC |
| Country | United States |
| FEI number | 3005747797 |
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: