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Recall Observatory FDA recall evidence

Device product

Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires

Z-1736-2025

March 27, 2025

Class II

Product summary

Firm
Galt Medical Corporation
Event
Event 96622
Status
Ongoing
Classification
Class II
Quantity
200 needles
Official record key
device-enforcement:Z-1736-2025

Official wording

Reason: Due to a potential open seal in the sterile barrier packaging.

Code information: Catalog Number: NDL-107-04 UDI-DI code: 00841268102729 Lot Number: 24108670

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