Home / Recalls / Medical Devices
TELEFLEX LLC recalls Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tr
Recalled May 24, 2023 · FDA recall Z-1611-2023 · TELEFLEX
Hazard
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. · FDA Class II
Units
1140 units
Sold at
US Nationwide
Description
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.
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.
Manufacturer(s)
TELEFLEX LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →