BEUDAMED
    FDA Enforcement Class II Terminated

    Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic procedures to study the function of the bladder and urethra during filling and voiding, by monitoring pressure and pressure changes.

    Recall: Z-2535-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2535-2020
    Event ID
    85655
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LABORIE MEDICAL TECHNOLOGIES, CANADA ULC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 15, 2020
    Initiation Date
    April 22, 2020
    Classification Date
    July 8, 2020
    Termination Date
    April 25, 2021
    Address
    6415 Northwest Dr Unit 11, Mississauga, N/A, Canada

    Description

    Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic procedures to study the function of the bladder and urethra during filling and voiding, by monitoring pressure and pressure changes.

    Reason

    This field correction is being initiated to address potentially damaged seals in the packaging of some the Laborie Pump Tube Sets. Finished goods inventory was detected with damage to their seals in the form of breaches or folds. Based on our investigation the issue appears to be limited to a single lot of part number 902101226 pump tubing sets.

    Code Info

    Model Number: REF 902101226, LOT 15883/1

    Distribution

    US Nationwide distribution including in the states of CO, FL, IN, MI, NJ, NY, OH, OR, PA and TX.

    Quantity

    480 units