BEUDAMED
    FDA Enforcement Class II Terminated

    CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US

    Recall: Z-0938-2022 · Reported April 20, 2022

    Enforcement

    Recall Number
    Z-0938-2022
    Event ID
    89810
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Graphic Controls Acquisition Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 20, 2022
    Initiation Date
    March 15, 2022
    Classification Date
    April 14, 2022
    Termination Date
    July 12, 2024
    Address
    400 Exchange St, N/A, Buffalo, NY, 14204-2064, United States

    Description

    CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US

    Reason

    Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.

    Code Info

    All lots UDI: 03700506307326

    Distribution

    US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT.

    Quantity

    8265 units