Skip to content
Recall Observatory FDA recall evidence

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

March 27, 2025

Class II

Product summary

Firm
Galt Medical Corporation
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

    reason.labeling_packaging · v1.0.0

    open seal