Device product
Namic FLUID DELIVERY SET, REF 91300040
Z-1807-2024
Product summary
- Event
- Event 94313
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 50 units
- Official record key
device-enforcement:Z-1807-2024
Official wording
Reason: Products have a lack of sterility assurance.
Code information: UDI/DI 20193489069096 (box), 10193489069099 (unit), Lot Numbers: 0000113381
Distribution pattern: US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX.
Derived failure modes
-
Sterility assurance
lack of sterility