Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat Recalled by TELEFLEX LLC Due to The product contains an expired diluent vial. If...

Date: April 12, 2023
Company: TELEFLEX LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact TELEFLEX LLC directly.

Affected 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.

Quantity: 1140 units

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About TELEFLEX LLC

TELEFLEX LLC has 139 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report