# FDA recall Z-1218-2019

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2018-08-22.

## 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

- **Recall number:** Z-1218-2019
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1218-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1218-2019. Source: US FDA. Licensed CC0.

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