🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: April 12, 2023 TELEFLEX Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI/DI M20640000, Lot Numbers: 717535, exp. 04/27/2023; 717413, exp. 04/25/2023
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
TELEFLEX LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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 Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1611-2023

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