Recall Z-1611-2023— TELEFLEX LLC
Class II · Ongoing
Class II FDA medical device recall by TELEFLEX LLC, initiated 2023-04-12. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- TELEFLEX LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-04-12
- Firm location
- Morrisville, NC, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.