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FDA (Device enforcement)Recalled 2025-03-27class ii

Galt Medical Corporation: 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 i

Hazard

Due to a potential open seal in the sterile barrier packaging.

Details from the source

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. Quantity: 490 units Lot/code info: Catalog Number: KIT-051-01, UDI-DI code: 00841268106130 Lot Numbers: 24298473 24190504 INT-101-15, UDI-DI code: 00841268107380 Lot Number: 24284447

UPC codes

00841268106130, 00841268107380

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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