TELEFLEX LLC: Medical Device Recall in 2023 - (Recall #: Z-1611-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 12, 2023

Date Posted: May 24, 2023

Recall Number: Z-1611-2023

Event ID: 92090

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.

Status: Ongoing

Product Quantity: 1140 units

Code Information:

UDI/DI M20640000, Lot Numbers: 717535, exp. 04/27/2023; 717413, exp. 04/25/2023

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated