Device product
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
Z-1736-2025
Product summary
- 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
open seal