BEUDAMED
    FDA Enforcement Class II Terminated

    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C

    Recall: Z-1889-2019 · Reported July 3, 2019

    Enforcement

    Recall Number
    Z-1889-2019
    Event ID
    82973
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ethicon Endo-Surgery Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2019
    Initiation Date
    May 15, 2019
    Classification Date
    June 26, 2019
    Termination Date
    June 11, 2020
    Address
    4545 Creek Rd, N/A, Blue Ash, OH, 45242-2803, United States

    Description

    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C

    Reason

    Observed reported incidence rate for harm associated with intraoperative bleeding

    Code Info

    All lot numbers

    Distribution

    Nationwide Foreign: CANADA, AUSTRALIA, BELGIUM

    Quantity

    1059 boxes