BEUDAMED
    FDA Enforcement Class II Terminated

    Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubular structures.

    Recall: Z-1212-2019 · Reported May 1, 2019

    Enforcement

    Recall Number
    Z-1212-2019
    Event ID
    82426
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    COVIDIEN LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 1, 2019
    Initiation Date
    March 13, 2019
    Classification Date
    April 23, 2019
    Termination Date
    April 23, 2020
    Address
    15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States

    Description

    Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubular structures.

    Reason

    Sterilization method used was not consistent with the labeling and the approved sterilization method

    Code Info

    Lot Numbers: P8D1335PRX P8D1336PRX P8D1605PRX

    Distribution

    Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.

    Quantity

    240 units