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.
Reported: May 24, 2023 Initiated: April 12, 2023 #Z-1611-2023
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.
Details
- Recalling Firm
- TELEFLEX LLC
- Units Affected
- 1140 units
- Distribution
- US Nationwide
- Location
- Morrisville, NC
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by TELEFLEX LLC. Units affected: 1140 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 24, 2023. Severity: Moderate. Recall number: Z-1611-2023.
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