Home / Recalls / Medical Devices
Galt Medical Corporation recalls B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introduce
Recalled May 14, 2025 · FDA recall Z-1732-2025 · Galt Medical
Hazard
Due to a potential open seal in the sterile barrier packaging . · FDA Class II
Units
1,400 dilators
Sold at
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.
Description
Due to a potential open seal in the sterile barrier packaging .
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.
Manufacturer(s)
Galt Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →