BEUDAMED
    FDA Recall Open, Classified

    RUSCH POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

    Recall: Z-1294-2021 · Initiated February 18, 2021

    Recall

    Recall Number
    Z-1294-2021
    Event Number
    87370
    Firm
    TELEFLEX MEDICAL INC
    FEI Number
    3005747797
    Product Code
    CCW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 18, 2021
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

    Description

    RUSCH POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

    Reason

    Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge.

    Action

    The US consignee notification letter "Urgent Medical Device Recall Notification" and Recall Acknowledgement form sent on 02/18/2021 via FedEx 2-day mail.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI. The country of Canada.

    Quantity

    157, 150 units (156,980 units in the US; 170 units OUS)