Device product
Sterile Radiology Procedure Kits, Model Number DYNDH1491B
Z-1693-2026
Product summary
- Event
- Event 98529
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 420 units
- Official record key
device-enforcement:Z-1693-2026
Official wording
Reason: There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
Code information: UDI-DI: (CS) 40198459071455, (EA) 10198459071454; Lot Number: 25GBB924
Distribution pattern: US Nationwide distribution in the state of MN.
Derived failure modes
-
Sterility assurance
sterile pouch packaging for one lot of radiology kits, which may compromise