FDA-Device2023-05-24Class II
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.
TELEFLEX LLC
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.
Sold states
US Nationwide
Affected count
1140 units
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1611-2023Don't want to check this manually?
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