FDAClass IIMay 1, 2019

Jelco(R) ViaValve(TM) safety intravenous recall

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…

Why was Jelco(R) ViaValve(TM) safety intravenous recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Smiths Medical ASD Inc.
Quantity
136,600 units
Distribution
Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, and New Zealand.
Recall date
May 1, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls