BEUDAMED
    FDA Enforcement Class II Terminated

    Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.

    Recall: Z-0787-2020 · Reported January 15, 2020

    Enforcement

    Recall Number
    Z-0787-2020
    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

    Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. 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: 2182536, 2182852, 2183161, 2190350, 2190531, 2190617, 2191025, 2191591

    Distribution

    US Nationwide

    Quantity

    50,400 pieces