FDA recall Z-1218-2019

Smiths Medical ASD Inc. · Class II · 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.

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

Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, and New Zealand.

Key facts

Status: Terminated
Initiation date: 2018-08-22
Report date: 2019-05-01
Termination date: 2021-02-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1218-2019