—#166806

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.

FDA product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K160235
Affected lot / code info: Lot Numbers: 3584467, 3584468, 3584469, 3576073, 3576233, 3578511, 3578512

Why it was 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.

Root cause (FDA determination)

Process design

Action the firm took

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 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: fieldactions@smiths-medical.com.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, and New Zealand.

Timeline

Recall initiated: 2018-08-22
Terminated: 2021-02-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166806. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.