BEUDAMED
    FDA Enforcement Class II 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 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2206-2019
    Event ID
    83485
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 14, 2019
    Initiation Date
    July 19, 2019
    Classification Date
    August 7, 2019
    Termination Date
    May 22, 2020
    Address
    311 Enterprise Dr, N/A, Plainsboro, NJ, 08536-3344, United States

    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

    Code Info

    Lot # J2670Y

    Distribution

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

    Quantity

    125 units