BEUDAMED
    FDA Enforcement Class II 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 · Reported January 8, 2014

    Enforcement

    Recall Number
    Z-0606-2014
    Event ID
    66902
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Instrumentation Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 8, 2014
    Initiation Date
    November 13, 2013
    Classification Date
    December 29, 2013
    Termination Date
    July 9, 2014
    Address
    2990 Industrial Blvd, Bethel Park, PA, 15102-2536, United States

    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.

    Code Info

    multiple lots shipped between 10/7/13 and 11/6/13: P1002913, P1004413, P1005713, P1007713, P1009813, P1014213, P1014813, and P1102013.

    Distribution

    Nationwide Distribution.

    Quantity

    220