BEUDAMED
    FDA Enforcement Class I Terminated

    Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .

    Recall: Z-1058-2013 · Reported April 17, 2013

    Enforcement

    Recall Number
    Z-1058-2013
    Event ID
    64751
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Engineered Medical Systems,Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 17, 2013
    Initiation Date
    September 12, 2011
    Classification Date
    April 10, 2013
    Termination Date
    August 2, 2013
    Address
    2055 Executive Drive, Indianapolis, IN, 46241-4311, United States

    Description

    Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .

    Reason

    The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.

    Code Info

    REF 8-205508-00 Lot Number: 820550800110419.

    Distribution

    Distributed in the states of PA, IN, NY, CO, and CA.

    Quantity

    1500pcs, 75cs {20pcs per cases)