BEUDAMED
    FDA Recall Terminated

    RTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aerosolized medication delivery system having an elliptical mouthpiece to a ventilator circuit.

    Recall: Z-0606-2014 · Initiated November 13, 2013

    Recall

    Recall Number
    Z-0606-2014
    Event Number
    66902
    Firm
    Instrumentation Industries Inc
    FEI Number
    2518436
    Product Code
    CAI
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    November 13, 2013
    Posted
    December 29, 2013
    Terminated
    July 9, 2014
    Address
    2990 Industrial Blvd, Bethel Park, PA, 15102-2536

    Description

    RTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aerosolized medication delivery system having an elliptical mouthpiece to a ventilator circuit.

    Reason

    Some packages of the RTC 25-C may have been shipped to customers with incomplete Installation and Usage Directions due to a printing error.

    Action

    A recall notification letter, dated November 13, 2013, was sent to Users.

    Distribution

    Nationwide Distribution.

    Quantity

    220