BEUDAMED
    FDA Recall Terminated

    MVP-10 Pediatric/ Neonatal Volume Ventilator

    Recall: Z-0300-04 · Initiated November 7, 2003

    Recall

    Recall Number
    Z-0300-04
    Event Number
    27937
    Firm
    Bio-Med Devices, Inc.
    FEI Number
    3003952420
    Product Code
    MNT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 7, 2003
    Posted
    January 6, 2004
    Terminated
    February 1, 2016
    Address
    1445 Boston Post Rd, Guilford, CT, 06437-4338

    Description

    MVP-10 Pediatric/ Neonatal Volume Ventilator

    Reason

    Two way relief valve may fail to activate at the low negative pressure of -3cm H2O.

    Action

    Bio Med Devices notified accounts by telephone on 11/7/03, to return the device for replacement and correction.

    Distribution

    ID, PA, TX

    Quantity

    3 units