BEUDAMED
    FDA Recall Terminated

    CADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid deliver from an IV bag.

    Recall: Z-2589-2017 · Initiated May 15, 2017

    Recall

    Recall Number
    Z-2589-2017
    Event Number
    77284
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 15, 2017
    Terminated
    April 4, 2018
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    CADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid deliver from an IV bag.

    Reason

    One lot of CADD High Volume Administration sets, part number 21-7381-24, lot number 26X035, incorrectly contained the IFU insert for part number 21-7357-24.

    Action

    Consignees were sent on 5/15/2017 a Smiths Medical "Urgent Medical device Recall Notice" dated May 15, 2017. The letter described the Affected Devices, Reason for Recall, Risk to Health, & Instructions to Customers. Advised consignees to complete and send the Urgent Medical Device Recall Response Form to [email protected] within 10 calendar days of receipt of this Notice.If you have distributed affected devices to your customers, immediately notify your customers of this Recall and retrieve all affected devices. For questions contact Stericycle via email at: [email protected].

    Distribution

    US Nationwide in the states of PA, TN, NV, CA, MD, AR, CA, VA, OH, MN, NY, VT, NY.

    Quantity

    7,035