GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to ...
FDA Recall #Z-1734-2025 — Class II — March 27, 2025
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.
Recalling Firm
Galt Medical Corporation — Garland, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
100 guidewires
Distribution
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated