BEUDAMED
    FDA Enforcement Class III Terminated

    ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.

    Recall: Z-1596-2015 · Reported May 20, 2015

    Enforcement

    Recall Number
    Z-1596-2015
    Event ID
    70662
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arc Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    May 20, 2015
    Initiation Date
    February 19, 2015
    Classification Date
    May 8, 2015
    Termination Date
    August 29, 2017
    Address
    4296 Cowan Rd, N/A, Tucker, GA, 30084-4800, United States

    Description

    ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.

    Reason

    Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.

    Code Info

    Product code: 6160, Batch number: 110208-50

    Distribution

    Distributed in CA and NC.

    Quantity

    1810 units