GALT Guidewire recall: Sterility Concern
GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional…
Why was GALT Guidewire recalled?
Due to a potential open seal in the sterile barrier packaging.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: SGW-051-07 UDI-DI code: 0084126810132 Lot Number: 25050797
- Product
- GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional…
- Recalling firm
- Galt Medical Corporation
- Quantity
- 100 guidewires
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.
- Recall date
- May 14, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)