Recall Z-1218-2019 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Smiths Medical ASD Inc.
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.
| Date | Aug 22, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process design |
| Action | Smiths Medical delivered an "URGENT MEDICAL DEVICE RECALL NOTICE" dated 8/22/2018 and accompanying Recall Response Forms via tracked mail on 08/22/2018 to all consignees who purchased potentially affected product. The notices describe the product, problem and actions to be taken. The consignees were instructed to do the following: 1. Locate affected Jelco ViaValve" safety I.V. catheters in your possession 2. Determine the number of affected devices in your possession and complete the Recall Response Form within 10 days of receipt, returning it to SmithsMedical6697@stericycle.com. The form mu |
| Quantity | 136,600 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160235 | ViaValve Safety I.V. Catheter Smiths Medical Asd, Inc., Jun 30, 2016 |