BEUDAMED
    FDA Recall 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 · Initiated November 4, 2014

    Recall

    Recall Number
    Z-0494-2015
    Event Number
    69805
    Firm
    Aircraft Medical Limited 9-10 SAINT ANDREW SQUARE EDINBURGH United Kingdom
    FEI Number
    3005416399
    Product Code
    CCW
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    November 4, 2014
    Posted
    December 2, 2014
    Terminated
    November 17, 2017

    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.

    Action

    Aircraft Medical Limited sent a recall notification letter dated November 4, 2014 to the sole US consignee. The letter included instructions for the consignee to: 1) check its own stock and its customers' stock for the recalled products; 2) arrange for any remaining stock to be removed from use. Customers with any questions can contact Aircraft Medical by e-mail at [email protected].

    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)