BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1218-2019 · Initiated August 22, 2018

    Recall

    Recall Number
    Z-1218-2019
    Event Number
    80887
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    August 22, 2018
    Terminated
    February 11, 2021
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    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

    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.

    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].

    Distribution

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

    Quantity

    136,600 units