Device product
Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic, single use, radiopaque intravascular catheter device used for the administration of medically prescribed fluids, designed to reduce the risk of accidental secondary needle sticks.
Z-1218-2019
Product summary
- Event
- Event 80887
- Status
- Terminated
- Classification
- Class II
- Quantity
- 136,600 units
- Official record key
device-enforcement:Z-1218-2019
Official wording
Reason: Several lots of Jelco¿ ViaValve" safety intravenous (I.V.) catheters exhibited a V shaped puncture at the base of the catheter near the hub due to an adjustment that was made in the manufacturing process.
Code information: Lot Numbers: 3584467, 3584468, 3584469, 3576073, 3576233, 3578511, 3578512
Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, and New Zealand.
Derived failure modes
-
Unknown
Several lots of Jelco¿ ViaValve" safety intravenous (I.V.) catheters exhibited a V shaped puncture at the base of the catheter near the hub due to an adjustment that was made in the manufacturing process.