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Recall Observatory FDA recall evidence

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

March 27, 2025

Class II

Product summary

Firm
Galt Medical Corporation
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

    reason.labeling_packaging · v1.0.0

    open seal