Smiths Medical ASD Inc.: Medical Device Recall in 2019 - (Recall #: Z-1218-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 22, 2018

Date Posted: May 1, 2019

Recall Number: Z-1218-2019

Event ID: 80887

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.

Status: Terminated

Product Quantity: 136,600 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated