BEUDAMED
    FDA Enforcement Class II Terminated

    Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.

    Recall: Z-0784-2020 · Reported January 15, 2020

    Enforcement

    Recall Number
    Z-0784-2020
    Event ID
    83527
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intersurgical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 15, 2020
    Initiation Date
    August 7, 2019
    Classification Date
    January 8, 2020
    Termination Date
    December 15, 2020
    Address
    6757 Kinne St, N/A, East Syracuse, NY, 13057-1215, United States

    Description

    Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.

    Reason

    The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.

    Code Info

    Lot numbers: 2181793, 2182007, 2182830, 2183105, 2183345(3183345), 2190034, 2190139, 2191204, 2191327

    Distribution

    US Nationwide

    Quantity

    115,200 pieces