Recall Z-1735-2025— Galt Medical Corporation

Name: FDA recall Z-1735-2025
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- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-38, 00841268108394 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the peripheral vascular system following a small gauge needle stick.. 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- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-38, 00841268108394 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the peripheral vascular system following a small gauge needle stick.

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.