BEUDAMED
    FDA Enforcement Class II Terminated

    McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. Product Usage: Single Use, sterile video laryngoscope blade for use with McGRATH MAC Video Laryngoscopes

    Recall: Z-0494-2015 · Reported December 10, 2014

    Enforcement

    Recall Number
    Z-0494-2015
    Event ID
    69805
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aircraft Medical Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 10, 2014
    Initiation Date
    November 4, 2014
    Classification Date
    December 2, 2014
    Termination Date
    November 17, 2017
    Address
    9-10 SAINT ANDREW SQUARE, N/A, EDINBURGH, N/A, N/A, United Kingdom

    Description

    McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. Product Usage: Single Use, sterile video laryngoscope blade for use with McGRATH MAC Video Laryngoscopes

    Reason

    The blade retaining clip may be difficult to engage and thereby increase the possibility of a blade becoming disconnected during intubation, specifically when the device is being retracted from the patients mouth.

    Code Info

    Product Code: 350-017-000. Lot Numbers and Expiration Dates: Lot 13121202, Expires 2016/12/11; Lot 13122301, Expires 2016/12/25; Lot 13042401, Expires 2017/5/5; Lot 14030501, Expires 2017/3/16; Lot 14031814, Expires 2017/3/26; Lot 14061616, Expires 2017/6/25.

    Distribution

    Worldwide Distribution - US Nationwide in the state of GA and the countries of Austria, China, Denmark, Finland, France, Hong Kong, Israel, Italy, Netherlands, Poland, Saudi Arabia, Singapore, South Korea, Taiwan, and Turkey.

    Quantity

    40,900 blades (US); 16,000 blades (Foreign)