BEUDAMED
    FDA Recall 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 · Initiated August 31, 2017

    Recall

    Recall Number
    Z-0695-2018
    Event Number
    79117
    Firm
    DePuy Mitek, Inc., a Johnson & Johnson Co.
    FEI Number
    1221934
    Product Code
    JCY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 31, 2017
    Terminated
    April 9, 2019
    Address
    325 Paramount Dr, Raynham, MA, 02767-5199

    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

    Action

    On September 6, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to customers titled "FMS Gravity Tubing" requesting that customers cease further distribution or use, quarantine all remaining products and contact sales consultant for the coordination of return and replacement. Questions or concerns can be directed to the recall coordinator at 508-828-6609

    Distribution

    US Nationwide Distribution

    Quantity

    15,678