BEUDAMED
    FDA Recall Terminated

    TLS2 Thermal Ligating Shears, Catalog Number 132-131D

    Recall: Z-1698-2019 · Initiated March 22, 2019

    Recall

    Recall Number
    Z-1698-2019
    Event Number
    82708
    Firm
    Microline Surgical, Inc.
    FEI Number
    1000137656
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 22, 2019
    Terminated
    July 30, 2020
    Address
    50 Dunham Rd, Suite 1500, Beverly, MA, 01915-1882

    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.

    Action

    Urgent Medical Device Recall letters dated 3/22/19 were sent to customers.

    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