FDAApril 12, 2023device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
teleflex
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAEndotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120820552023-05-25
- FDAEndotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120820502023-05-25
- FDAEndotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120800952023-05-25
- FDAEndotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120800552023-05-25
- FDARUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 1124800302023-05-25
- FDAEndotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120801002023-05-25
- FDAEndotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120820902023-05-25
- FDAEndotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120820602023-05-25
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