Jelco ViaValve Safety Intravenous Catheters Recalled for Manufacturing Defect
Smiths Medical ASD Inc. is recalling specific lots of Jelco ViaValve safety intravenous catheters due to a V-shaped puncture at the base of the catheter.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD Inc. is recalling 136,600 units of Jelco ViaValve safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10. The affected lots are 3584467, 3584468, 3584469, 3576073, 3576233, 3578511, and 3578512. These sterile, single-use devices are used for the administration of medically prescribed fluids.
The recall was initiated because several lots exhibited a V-shaped puncture at the base of the catheter near the hub. This defect resulted from an adjustment made in the manufacturing process. The agency has classified this recall as Class II.
The affected products were distributed nationwide in the United States, as well as in Canada, Australia, and New Zealand. Healthcare facilities and distributors should check their inventory for the specific lot numbers listed and stop using the affected devices.
The recalled product
- 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…
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- Affected units
- 136,600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot Numbers: 3584467
- 3584468
- 3584469
- 3576073
- 3576233
- 3578511
- 3578512
Distribution
Distributed nationwide across the United States.
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