FDA recall Z-1737-2025

Galt Medical Corporation · Class II · device

Product

Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.

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-1737-2025