BEUDAMED
    FDA Recall 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 · Initiated March 13, 2019

    Recall

    Recall Number
    Z-1212-2019
    Event Number
    82426
    Firm
    COVIDIEN LLC
    FEI Number
    1282497
    Product Code
    HDA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 13, 2019
    Terminated
    April 23, 2020
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113

    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

    Action

    Medtronic notified consignees via an "URGENT MEDICAL DEVICE RECALL" letter by Federal Express and/or certified mail on March 13, 2019. The letter informs customers of the recall of twenty-one production lot of Covidien Endo Clinch" and Endo Grasp" Auto Suture" graspers 5mm as the sterilization method used for these lots was not consistent with the labeling and the approved sterilization method. Customers are instructed to take the following actions: 1. Please immediately quarantine and discontinue use of the affected item codes and lots listed above. 2. Please return affected product as indicated below. 3. If you have distributed the Endo Clinch" II or Endo Grasp" Auto Suture" graspers 5mm listed above, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory. -----If you have inventory email to: [email protected] fax to: 800-895-6140. -----Exception: Customers with zero inventory, fax to 203-492-7719 or email to [email protected] If purchased by distributor, fax to 203-492-7719 or email [email protected]. If you have any questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at 800-962-9888, option 2.

    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