FDA recall Z-1732-2025

Galt Medical Corporation · Class II · device

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 for recall

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

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2025-03-27
Report date
2025-05-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Garland, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1732-2025