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.
Z-1737-2025
Product summary
- Event
- Event 96622
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 490 units
- Official record key
device-enforcement:Z-1737-2025
Official wording
Reason: Due to a potential open seal in the sterile barrier packaging.
Code information: Catalog Number: KIT-051-01, UDI-DI code: 00841268106130 Lot Numbers: 24298473 24190504 INT-101-15, UDI-DI code: 00841268107380 Lot Number: 24284447
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
open seal