Z-1734-2025 Class II Ongoing

Recalled by Galt Medical Corporation — Garland, TX

Recall Details

Product Type
Devices
Report Date
May 14, 2025
Initiation Date
March 27, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
100 guidewires

Product Description

GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.

Reason for Recall

Due to a potential open seal in the sterile barrier packaging.

Distribution Pattern

Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.

Code Information

Catalog Number: SGW-051-07 UDI-DI code: 0084126810132 Lot Number: 25050797