Recall Z-1732-2025— Galt Medical Corporation

Name: FDA recall Z-1732-2025
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. It names one FDA 510(k) clearance: K000737. Product: B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the 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

510(k) clearances named in this recall

1 on FDA's record

K000737 — COAXIAL DILATOR SETXentek Medical, Inc.·cleared 2000-08-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the 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.