Galt Medical Corporation recalls Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are use…

Recall date

March 27, 2025

Source

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

Recall number

Z-1737-2025

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

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.