Teleflex D-Stat Flowable Hemostat Recalled for Expired Diluent Vial
Teleflex is recalling D-Stat Flowable Hemostat units with expired diluent vials that cannot assure sterility. No illnesses or injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device recall with no reported illnesses or injuries. The expired diluent creates a theoretical loss of sterility assurance, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Teleflex LLC is recalling 1140 units of D-Stat Flowable Hemostat (REF 4000) distributed nationwide in the United States. The affected lot numbers are 717535 and 717413. The device is intended for sealing residual oozing of tissue tracts at femoral access sites previously closed by suture or collagen-based hemostatic devices.
The recalled product contains an expired diluent vial. The diluent component has passed beyond its studied shelf life, meaning the sterility of this component cannot be assured. If the product is used, the sterility assurance of the diluent is compromised.
The recalled 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
- TELEFLEX LLC
- Hazard
- sterility-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI/DI M20640000
- Lot Numbers: 717535
- exp. 04/27/2023
- 717413
- exp. 04/25/2023
Distribution
Distributed nationwide across the United States.
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