BEUDAMED
    FDA Enforcement Class II Terminated

    IVEA 500A Intended for Med-Surg patient care.

    Recall: Z-0767-2017 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0767-2017
    Event ID
    75571
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Firefly Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2016
    Initiation Date
    November 1, 2016
    Classification Date
    December 15, 2016
    Termination Date
    August 1, 2017
    Address
    320 E Vine Dr Ste 312, Fort Collins, CO, 80524-2332, United States

    Description

    IVEA 500A Intended for Med-Surg patient care.

    Reason

    The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.

    Code Info

    Product Part Number 16100. Serial Numbers 100200-101068, except for serial numbers within this range not released into final inventory for other reasons.

    Distribution

    Worldwide Distribution -- USA and Canada.

    Quantity

    239