Galt Medical Corporation recalls B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits…

Recall date

March 27, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1732-2025

FDA classification

Class II

Brand / firm

Galt Medical Corporation

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.