BEUDAMED
    FDA Recall 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 · Initiated September 7, 2016

    Recall

    Recall Number
    Z-0075-2017
    Event Number
    75274
    Firm
    Banyan Medical, LLC
    FEI Number
    3009770724
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 7, 2016
    Terminated
    March 9, 2021
    Address
    89 Bellows St, Warwick, RI, 02888-1503

    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

    Action

    Banyan Medical issued Urgent Voluntary Recall Notification on 9/7/16 to Distributors to remove product from inventory and contact hospital to examine and return product. Questions contact your local Banyan Sales Representative

    Distribution

    IN, TN

    Quantity

    64 boxes of 5