Z-1218-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2019
- Initiation Date
- August 22, 2018
- Termination Date
- February 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 136,600 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, and New Zealand.
Code Information
Lot Numbers: 3584467, 3584468, 3584469, 3576073, 3576233, 3578511, 3578512