Z-1218-2019 Class II Terminated
FDA device recall Z-1218-2019 was initiated by Smiths Medical ASD Inc. on Aug 22, 2018 and is designated Class II. 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… The recall status is terminated (terminated Feb 11, 2021). Affected quantity: 136,600 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2019
- Initiation Date
- Aug 22, 2018
- Termination Date
- Feb 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1218-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026