Tearaway Introducer Kit Recalled Due to Potential Connector Defect
Galt Medical Corporation is recalling Tearaway Introducer Kits due to potential cracking or dislodging of the luer connection during use, which can render the device unusable and require replacement.
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: This is a Class II medical device recall with no reported injuries or illnesses. The hazard—a potential connector defect that could render the device unusable during clinical use—presents a risk of harm without reported adverse events, meeting the rubric criterion for High severity.
Plain-English summary
Galt Medical Corporation is recalling the Tearaway Introducer Kit (model references KIT-010-12, KIT-010-17, and KIT-900-16) due to a potential defect in the luer connection of the dilator hub.
Under improper storage conditions, the luer connection can crack or dislodge during clinical use, rendering the dilator component unusable and requiring replacement with another device.
The recall affects 490 units distributed in the United States and internationally to the United Kingdom, Australia, Turkey, France, Switzerland, and Norway. The FDA has classified this as a Class II recall.
If you have received one of these kits, contact Galt Medical Corporation regarding replacement or handling instructions.
The recalled product
- Product
- Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
- Manufacturer
- Galt Medical Corporation
- Hazard
- connector-defect
- device-malfunction
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 (6)
- REF/UDI-DI/LOT (Expiration): KIT-010-12/00841268105195/S23104607(2/05/2027)
- S22356870(1/11/2027)
- KIT-010-17/00841268105249/S23083725(2/05/2027)
- S22231321(9/08/2026)
- S22328872(1/18/2027)
- KIT-900-16/S22308637(1/04/2027)
Distribution
Distributed nationwide across the United States.
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