BEUDAMED
    FDA Enforcement Class II Terminated

    Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.

    Recall: Z-1635-2014 · Reported May 28, 2014

    Enforcement

    Recall Number
    Z-1635-2014
    Event ID
    68012
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microline Surgical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 28, 2014
    Initiation Date
    April 14, 2014
    Classification Date
    May 20, 2014
    Termination Date
    September 2, 2015
    Address
    50 Dunham Rd, N/A, Beverly, MA, 01915-1882, United States

    Description

    Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.

    Reason

    Grasper jaw may break when force is applied to the jaw

    Code Info

    Lot Numbers: 00116169 and 00115866

    Distribution

    Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile.

    Quantity

    540 units