FDA recall Z-1734-2025

Galt Medical Corporation · Class II · device

Product

GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.

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-1734-2025