Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of ...
FDA Recall #Z-1736-2025 — Class II — March 27, 2025
Product Description
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
Reason for Recall
Due to a potential open seal in the sterile barrier packaging.
Recalling Firm
Galt Medical Corporation — Garland, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
200 needles
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.
Code Information
Catalog Number: NDL-107-04 UDI-DI code: 00841268102729 Lot Number: 24108670
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated