BEUDAMED
    FDA Enforcement Class II Terminated

    TLS2 Thermal Ligating Shears, Catalog Number 132-131D

    Recall: Z-1698-2019 · Reported June 12, 2019

    Enforcement

    Recall Number
    Z-1698-2019
    Event ID
    82708
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microline Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2019
    Initiation Date
    March 22, 2019
    Classification Date
    May 31, 2019
    Termination Date
    July 30, 2020
    Address
    50 Dunham Rd, Suite 1500, Beverly, MA, 01915-1882, United States

    Description

    TLS2 Thermal Ligating Shears, Catalog Number 132-131D

    Reason

    The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.

    Code Info

    UDI: 811099011439; Lot Numbers: 807118, 807119, 807120, 811076

    Distribution

    The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands.

    Quantity

    115 units