BEUDAMED
    FDA Recall Open, Classified

    McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid laryngoscope it holds and shapes the anatomy allowing a clear view of the larynx and entrance to the trachea.

    Recall: Z-1408-2020 · Initiated January 28, 2020

    Recall

    Recall Number
    Z-1408-2020
    Event Number
    84819
    Firm
    Medtronic, PLC
    FEI Number
    1219930
    Product Code
    CCW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 28, 2020
    Posted
    February 10, 2020
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid laryngoscope it holds and shapes the anatomy allowing a clear view of the larynx and entrance to the trachea.

    Reason

    Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles which may result in a change in optical performance as displayed on the video screen

    Action

    Medtronic issued Medical Device Correction letter via Federal Express and/or certified mail beginning January 28, 2020. The letter states reason for recall, health risk and action to take: dispose of affected product according to their institutions disposal procedures;" Notify all care environments about this notice in which the McGRATH" X3 disposable laryngoscope blades are used;" Promptly forward the information from the customer communication to any recipients to whom they have distributed any of the affected; product; Complete the acknowledgment and receipt form. Questions: Customer Service at (800) 448-3644, Option 2, Option 2.

    Distribution

    Worldwide distribution - US Nationwide and countries Australia, Canada, New Zealand, India, Korea, Japan, Indonesia, Malaysia, Philippines, Singapore, Vietnam, Latin America, France, Switzerland. Italy, Belgium, Germany, Netherlands, Denmark, Poland, Austria, Czech Republic, Croatia, Spain, Finland,Greece, Guadeloupe, Ireland, Hungry, Italy, Jordan, Kazakhstan, Lithuania, Lebanon, Luxembourg, Norway, Poland, Portugal, Reunion, Romania, Russian Federation, Saudia Arabia, Sweden, Serbia, Slovakia, Turkey, Tunisia, United Arab Emirates, United Kingdom.

    Quantity

    109,897