Class 2 Device Recall Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters

• Date Initiated by Firm: August 22, 2018
• Create Date: April 25, 2019
• Recall Status: Terminated on February 11, 2021
• Recall Number: Z-1218-2019
• Recall Event ID: 80887
• 510(K)Number: K160235
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• 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.
• Code Information: Lot Numbers: 3584467, 3584468, 3584469, 3576073, 3576233, 3578511, 3578512
• Recalling Firm/ Manufacturer: Smiths Medical ASD Inc.; 6000 Nathan Ln N; Minneapolis MN 55442-1690
• For Additional Information Contact: 763-383-3072
• Manufacturer 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.
• FDA Determined 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 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.
• Quantity in Commerce: 136,600 units
• Distribution: Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, and New Zealand.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FOZ