Recall Z-1737-2025— Galt Medical Corporation

Name: FDA recall Z-1737-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-27

Class II · Ongoing

Class II FDA medical device recall by Galt Medical Corporation, initiated 2025-03-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.. Reason: Due to a potential open seal in the sterile barrier packaging..

Recalling firm: Galt Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-03-27
Firm location: Garland, TX, United States

Product description

Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.