Device product
Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Component: No
Z-1426-2025
Product summary
- Event
- Event 96321
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 460 kits.
- Official record key
device-enforcement:Z-1426-2025
Official wording
Reason: Sterility assurance with procedure trays
Code information: Lot Code: UDI-DI: 00191072182845; Lot: 9219618; Exp: 01/21/2026
Distribution pattern: US: AZ OUS: None
Derived failure modes
-
Unknown
Sterility assurance with procedure trays