BEUDAMED
    FDA Enforcement Class II Terminated

    1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.

    Recall: Z-0695-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0695-2018
    Event ID
    79117
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Mitek, Inc., a Johnson & Johnson Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    August 31, 2017
    Classification Date
    February 23, 2018
    Termination Date
    April 9, 2019
    Address
    325 Paramount Dr, N/A, Raynham, MA, 02767-5199, United States

    Description

    1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.

    Reason

    Leakage of FMS gravity tub sets (281113) at the bulb and tube connection

    Code Info

    Lot codes: 138, 194, 633, 1067, 1741, 2576, 2608, and 2645

    Distribution

    US Nationwide Distribution

    Quantity

    15,678