BEUDAMED
    FDA Recall Terminated

    Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedures. Model # 8145100S

    Recall: Z-2206-2019 · Initiated July 19, 2019

    Recall

    Recall Number
    Z-2206-2019
    Event Number
    83485
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 19, 2019
    Terminated
    May 22, 2020
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedures. Model # 8145100S

    Reason

    Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected

    Action

    Integra LifeSciences issued recall letter on July 19, 2019 advising of problem, health risk and action to take: 1.Review your inventory and determine if you have any impacted lot. 2. If you do have product with an affected Lot Number, stop using the product immediately and remove the product from service. 3. Complete the attached form. If you do not have affected product, check the box, I do not have any product with the lot number. 4. If you do have affected product, check the box I do have product{s) with the lot number. Record the total quantity of affected product you have. 5. Complete the other information and Return the completed "Acknowledgement and Return Form" by email or fax indicating your receipt and review of this notification. Keep a copy of the form for your records. Customer Service will contact you and provide an RMA number and directions to return the product. A replacement order will also be placed for the quantity noted on the form. Customer Service Monday to Friday 8:00 AM - 8:00 PM EST USA: 1-800-654-2873: email: [email protected] Outside USA: 781-565-1401

    Distribution

    KY,NJ, RI, TX, WA Foreign: BE

    Quantity

    125 units