Z-1218-2019Class II

Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The...

Name: Z-1218-2019 Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The...
Creator: Smiths Medical ASD Inc.
Published: 2018-08-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-08-22 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of 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... on 2018-08-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1218-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-22
Posted: 2019-04-25
Terminated: 2021-02-11
Recalling firm: Abbott Medical
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.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
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.
Root cause tag: manufacturing process
FDA 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 [email protected]. The form must be returned even if you do not have any of the affected product in your possession. Product credit and/or replacement will be processed once the Recall Response Form is received and returned affected product has been verified. 3. All affected product must be returned to Stericycle for processing. Please include a copy of the completed Recall Response Form inside EACH BOX of returned product to facilitate processing. 4. DISTRIBUTORS: If you have distributed potentially affected product to your customers, please immediately notify them of this recall. If you have any questions, contact the Compliance Manager at 763-383-3310 or email to: [email protected].
Quantity in commerce: 136,600 units
Distribution: Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, and New Zealand.
Product codes and lots: Lot Numbers: 3584467, 3584468, 3584469, 3576073, 3576233, 3578511, 3578512

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1218-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1218-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-01	2019-04-25

Product code FOZ

K160235Class IIViaValve Safety I.V. CatheterSmiths Medical Asd, Inc. / cleared 2016-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)