Device 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.
Z-1734-2025
Product summary
- Event
- Event 96622
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 100 guidewires
- Official record key
device-enforcement:Z-1734-2025
Official wording
Reason: Due to a potential open seal in the sterile barrier packaging.
Code information: Catalog Number: SGW-051-07 UDI-DI code: 0084126810132 Lot Number: 25050797
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
open seal