BEUDAMED
    FDA Enforcement Class II Terminated

    Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009

    Recall: Z-0075-2017 · Reported October 19, 2016

    Enforcement

    Recall Number
    Z-0075-2017
    Event ID
    75274
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Banyan Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 19, 2016
    Initiation Date
    September 7, 2016
    Classification Date
    October 13, 2016
    Termination Date
    March 9, 2021
    Address
    89 Bellows St, N/A, Warwick, RI, 02888-1503, United States

    Description

    Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009

    Reason

    Potential lack of assurance of sterility

    Code Info

    Lot Numbers:140718, 160209

    Distribution

    IN, TN

    Quantity

    64 boxes of 5