Introducer Kit-Tearaway MicroSlide Medical Device Recall
Galt Medical Corporation is recalling Introducer Kit-Tearaway MicroSlide devices used to introduce catheters into blood vessels due to a potential open seal in the sterile barrier packaging. The affected units may not maintain sterility, creating a risk of infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a Class II recall of a sterile medical device where the sterile barrier has potentially been compromised. The hazard (loss of sterility) creates a risk of serious infection in invasive cardiovascular procedures; no reported illnesses are mentioned in the source, but the risk of harm to patients is significant and inherent to the hazard itself.
Plain-English summary
Galt Medical Corporation is recalling Introducer Kit-Tearaway MicroSlide devices (catalog numbers KIT-051-01 and INT-101-15) due to a potential open seal in the sterile barrier packaging. These introducers are used in procedures to introduce catheters and other intravascular devices into the coronary and peripheral blood vessels of adult and pediatric patients of all ages.
A total of 490 units have been distributed nationwide in the United States (AL, FL, GA, IL, MA, OH, PA, and UT), as well as internationally to Canada, Ireland, Israel, Korea, Qatar, and the United Kingdom. The affected lot numbers are 24298473, 24190504 (for KIT-051-01), and 24284447 (for INT-101-15).
If you have received or are using any affected units, do not use them. Contact Galt Medical Corporation directly for instructions on return or replacement of the recalled devices. A compromised sterile barrier may allow microbial contamination, which could lead to serious infection if used in clinical procedures.
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…
- Manufacturer
- Galt Medical Corporation
- Affected units
- 490
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
Part of a larger recall action
This product is one of 7 recalled by Galt Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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