GALT Guidewire Recalled for Potential Sterile Barrier Packaging Defect
Galt Medical Corporation is recalling GALT Guidewires due to a potential open seal in the sterile barrier packaging that could compromise product sterility.
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 with no illnesses or injuries reported. Potential open seal in sterile barrier packaging of a device used in invasive cardiovascular procedures creates a theoretical contamination risk, meeting criteria for High severity.
Plain-English summary
Galt Medical Corporation is recalling GALT Guidewires (Catalog Number SGW-051-07, Lot 25050797) due to a potential open seal in the sterile barrier packaging. The recall involves 100 guidewires.
The affected guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature. An open seal in the sterile barrier could compromise the sterility of the device, which is critical for safe use in invasive procedures.
The recalled products 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.
Healthcare providers and patients who have received these guidewires should verify lot numbers and contact Galt Medical Corporation or the FDA regarding the recall.
The recalled product
- Product
- GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.
- Manufacturer
- Galt Medical Corporation
- Hazard
- open-seal
- contamination-risk
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 (1)
- Catalog Number: SGW-051-07 UDI-DI code: 0084126810132 Lot Number: 25050797
Distribution
Distributed nationwide across the United States.
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