Introducer Kit Recalled for Potential Compromised Sterile Barrier Packaging
Galt Medical Corporation is recalling Introducer Kit - Tearaway MicroSlide due to a potential open seal in sterile barrier packaging. These devices are used to introduce catheters into coronary and peripheral blood vessels.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for medical device with compromised sterile barrier. No illnesses or injuries are reported in the source text; the hazard is theoretical contamination risk from potential open seal in packaging of devices used for intravascular procedures.
Plain-English summary
Galt Medical Corporation is recalling the Introducer Kit - Tearaway MicroSlide in two models: KIT-051-01 and INT-101-15. These medical devices are introducers used to guide catheters and other intravascular devices into coronary and peripheral blood vessels in adult and pediatric patients of all ages.
The recall is due to a potential open seal in the sterile barrier packaging of the affected units. A compromised sterile barrier could allow contamination of the device.
The recalled devices were distributed worldwide, with U.S. distribution in Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania, and Utah. International distribution included Canada, Ireland, Israel, Korea, Qatar, and the United Kingdom. Approximately 490 units are affected in lot numbers 24298473, 24190504, and 24284447.
This is an FDA Class II recall.
The recalled product
- 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
- Manufacturer
- Galt Medical Corporation
- Hazard
- sterile-barrier-compromise
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalog Number: KIT-051-01
- UDI-DI code: 00841268106130 Lot Numbers: 24298473 24190504 INT-101-15
- UDI-DI code: 00841268107380 Lot Number: 24284447
Distribution
Distributed nationwide across the United States.
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