GALT Guidewire SGW-051-07 Sterile Packaging Seal Defect Recall
Galt Medical Corporation is recalling GALT Guidewire model SGW-051-07 due to a potential open seal in the sterile barrier packaging. The defect may compromise the sterility of the device.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as Class II. The source text states only a potential defect (open seal) with no reported illnesses, injuries, or confirmed sterility compromise, making this a precautionary recall rather than an imminent health threat.
Plain-English summary
Galt Medical Corporation is recalling GALT Guidewire (Catalog Number SGW-051-07, UDI-DI code 0084126810132, Lot Number 25050797) due to a potential open seal in the sterile barrier packaging. The guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
The affected lot comprised 100 guidewires and was distributed nationwide in the United States (Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania, and Utah) as well as internationally to Canada, Ireland, Israel, Korea, Qatar, and the United Kingdom.
Healthcare providers and patients who have received this product should contact Galt Medical Corporation or their distributor to determine whether they may have received affected units. The potential open seal may compromise device sterility. Affected units should not be used and should be quarantined pending further instruction from the manufacturer.
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
- Affected units
- 100
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
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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