BEUDAMED
    FDA Enforcement Class II Ongoing

    Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.

    Recall: Z-1985-2019 · Reported July 24, 2019

    Enforcement

    Recall Number
    Z-1985-2019
    Event ID
    82967
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DJO, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 24, 2019
    Initiation Date
    January 17, 2019
    Classification Date
    July 18, 2019
    Address
    1430 Decision St, N/A, Vista, CA, 92081-8553, United States

    Description

    Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.

    Reason

    The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.

    Code Info

    Lot # 418003 UDI: (01)00888912302418

    Distribution

    Distributed domestically, Oklahoma

    Quantity

    9 units