CLASS II Device recall · Reported 1 May 2019 · FDA Enforcement Report

Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters1/4" recalled

Smiths Medical ASD is recalling Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters1/4", distributed nationwide in the US. The recall was initiated on 22 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 3584467, 3584468, 3584469, 3576073, 3576233, 3578511, 3578512

Quantity recalled136,600 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1218-2019
FDA event ID: 80887
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 22 Aug 2018
FDA classified: 25 Apr 2019
Reported: 1 May 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

22 Aug 2018	Recall initiated by company
25 Apr 2019	Classified by FDA	+246 days
1 May 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Numbers: 3584467, 3584468, 3584469, 3576073, 3576233, 3578511, 3578512

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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