Jelco — Class II medical device recall Z-1218-2019
Terminated recall by Smiths Medical ASD Inc., reported 2019-05-01, distributed nationwide. Several lots of Jelco¿ ViaValve" safety intravenous (I.V.) catheters exhibited a V shaped puncture at the base
| Recall number | Z-1218-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2018-08-22 |
| Classified | 2019-04-25 |
| Reported by FDA | 2019-05-01 |
| Terminated | 2021-02-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, NZ |
| Quantity | 136,600 units |
| Lot numbers | 3576073, 3576233, 3578511, 3578512, 3584467, 3584468, 3584469 |
| Model numbers | 3265 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1218-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.