GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Catalog Numbers: NT-104-06, INT-104-07, INT-104-08, INT-104-09, INT-104-10, INT-104-11, INT-104-12, INT-104-17, INT-104-18, INT-104-19, INT-104-20, INT-104-21, INT-104-22, INT-104-23, INT-108-06, INT-108-07, INT-108-09, INT-108-10, INT-108-11, INT-108-12, INT-108-17, INT-108-18, INT-108-19, INT-108-20, INT-108-21, INT-108-22, INT-108-22, VTI-002-06, VTI-002-07, VTI-002-08, VTI-002-09, VTI-002-09, VTI-002-10, VTI-002-11, VTI-002-12, VTI-002-17, VTI-002-18, VTI-002-19, VTI-002-20, VTI-002-21, VTI-002-22, VTI-002-23, VTI-003-06, VTI-003-07, VTI-003-08, VTI-003-09, VTI-003-10, VTI-003-11, VTI-003-12, VTI-003-17, VTI-003-18, VTI-003-19, VTI-003-20, VTI-003-21, VTI-003-22, and VTI-003-23.
  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:
Galt Medical Corporation
Reason for Recall:
The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

Product Codes/Lot Numbers:

Catalog Numbers: NT-104-06, INT-104-07, INT-104-08, INT-104-09, INT-104-10, INT-104-11, INT-104-12, INT-104-17, INT-104-18, INT-104-19, INT-104-20, INT-104-21, INT-104-22, INT-104-23, INT-108-06, INT-108-07, INT-108-09, INT-108-10, INT-108-11, INT-108-12, INT-108-17, INT-108-18, INT-108-19, INT-108-20, INT-108-21, INT-108-22, INT-108-22, VTI-002-06, VTI-002-07, VTI-002-08, VTI-002-09, VTI-002-09, VTI-002-10, VTI-002-11, VTI-002-12, VTI-002-17, VTI-002-18, VTI-002-19, VTI-002-20, VTI-002-21, VTI-002-22, VTI-002-23, VTI-003-06, VTI-003-07, VTI-003-08, VTI-003-09, VTI-003-10, VTI-003-11, VTI-003-12, VTI-003-17, VTI-003-18, VTI-003-19, VTI-003-20, VTI-003-21, VTI-003-22, and VTI-003-23.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2588-2014

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