BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1596-2015 · Initiated February 19, 2015

    Recall

    Recall Number
    Z-1596-2015
    Event Number
    70662
    Firm
    Arc Medical Inc
    FEI Number
    1000111925
    Product Code
    BYD
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 19, 2015
    Posted
    May 9, 2015
    Terminated
    August 29, 2017
    Address
    4296 Cowan Rd, Tucker, GA, 30084-4800

    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.

    Action

    Consignees were contacted by telephone on 02/19/2015.

    Distribution

    Distributed in CA and NC.

    Quantity

    1810 units