BEUDAMED
    FDA Recall Terminated

    DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.

    Recall: Z-2639-2017 · Initiated June 7, 2017

    Recall

    Recall Number
    Z-2639-2017
    Event Number
    77519
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    MAV
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    June 7, 2017
    Terminated
    July 22, 2020
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    Description

    DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.

    Reason

    Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility

    Action

    DeRoyal issued an Urgent Recall Notice dated June 7, 2017, to all affected customers. The customers were asked to identify the affected products and return the provided notice of return form back to DeRoyal indicating if replacement or credit is requested. Customers with questions were instructed to call 888-938-7828 or email [email protected]. For questions regarding this recall call 865-938-7828.

    Distribution

    Nationwide Distribution to MD, NY, and IL

    Quantity

    426 units