Device product
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 suture/collagen-based hemostatic devices.
Z-1611-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92090
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1140 units
- Official record key
device-enforcement:Z-1611-2023
Official wording
Reason: 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.
Code information: UDI/DI M20640000, Lot Numbers: 717535, exp. 04/27/2023; 717413, exp. 04/25/2023
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
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.