BEUDAMED
    FDA Recall Terminated

    Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.

    Recall: Z-0001-2016 · Initiated July 14, 2015

    Recall

    Recall Number
    Z-0001-2016
    Event Number
    71987
    Firm
    US Endoscopy Group Inc
    FEI Number
    1000122656
    Product Code
    FDI
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 14, 2015
    Posted
    October 1, 2015
    Terminated
    October 27, 2016
    Address
    5976 Heisley Rd, Mentor, OH, 44060-1873

    Description

    Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.

    Reason

    The company has determined the sterility cannot be assured for the affected lot.

    Action

    The firm, US Endoscopy, sent an "URGENT: HISTOLOCK" RESECTION DEVICE RECALL" letter and response form to their customers on July 14, 2015. The letter described the product, problem and action to be taken. The customers were instructed to complete the response form and return to your US Endoscopy Product Specialist and retain a copy of the letter for your records. If you have any questions, contact Sr. Manager, Reg. Affairs & Quality Compliance at 440-358-6251 or email at: [email protected].

    Distribution

    US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.

    Quantity

    41 units