Reported May 24, 2023 · Ongoing
Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue…
Teleflex LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TELEFLEX LLC · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
- Teleflex (manufacturerVascular 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
- Lot codes and dates
- UDI/DI M20640000
- Lot Numbers
717535exp. 04/27/2023717413exp. 04/25/2023
- Amount recalled
- 1140 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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