BEUDAMED
    FDA Recall 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 · Initiated April 22, 2020

    Recall

    Recall Number
    Z-2535-2020
    Event Number
    85655
    Firm
    LABORIE MEDICAL TECHNOLOGIES, CANADA ULC
    FEI Number
    3001438491
    Product Code
    FEZ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 22, 2020
    Terminated
    April 25, 2021
    Address
    6415 Northwest Dr, Unit 11, Mississauga 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.

    Action

    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.

    Distribution

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

    Quantity

    480 units