FDA-Device2025-05-14Class II
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.
Galt Medical Corporation
Hazard
Due to a potential open seal in the sterile barrier packaging.
Sold states
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.
Affected count
490 units
Manufactured in
2220 Merritt Dr, N/A, Garland, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1737-2025Don't want to check this manually?
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