BEUDAMED
    FDA Recall Terminated

    Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60 Days Negative Pressure Wound Therapy (Model 087.4014); d. Endure Negative Pressure Wound Therapy (Model 087.4020 ); e. 15 Days Negative Pressure Wound Therapy (Model 087.4022); f. 60 Days Negative Pressure Wound Therapy (Model 087.4024). Product Usage: The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) as it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

    Recall: Z-2528-2018 · Initiated February 7, 2018

    Recall

    Recall Number
    Z-2528-2018
    Event Number
    80078
    Firm
    Medela Inc
    FEI Number
    1419937
    Product Code
    OMP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 7, 2018
    Posted
    July 23, 2018
    Terminated
    December 4, 2018
    Address
    1101 Corporate Dr, McHenry, IL, 60050-7006

    Description

    Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60 Days Negative Pressure Wound Therapy (Model 087.4014); d. Endure Negative Pressure Wound Therapy (Model 087.4020 ); e. 15 Days Negative Pressure Wound Therapy (Model 087.4022); f. 60 Days Negative Pressure Wound Therapy (Model 087.4024). Product Usage: The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) as it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

    Reason

    Device may display a battery missing error.

    Action

    Medela sent an Notification letter dated February 1, 2018 to customers via Certified Mail. The letter identified the affected product, problem and actions to be taken. Instructions included to place all affected items on hold until an insert outlining additional charging instructions were included with the devices. Those instructions included to provide a printed copy of the charging instructions in each device package, review those insert instructions with patients and care-givers, and complete and return the confirmation letter. For questions contact Medela Partner Services at [email protected] or via phone 877-735-1626.

    Distribution

    US Nationwide Distribution domestically to AR, CA, FL, GA, IL, IN, LA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TX. Distributed internationally to Spain, Italy, Denmark, Sweden, Switzerland, Netherlands.

    Quantity

    778 units