BEUDAMED
    FDA Enforcement Class II Ongoing

    PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter

    Recall: Z-2466-2023 · Reported September 6, 2023

    Enforcement

    Recall Number
    Z-2466-2023
    Event ID
    92614
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 6, 2023
    Initiation Date
    July 18, 2023
    Classification Date
    August 28, 2023
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter

    Reason

    Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product

    Code Info

    UDI/DI 30351688410645, Lot Numbers: 3419998, 3420441, 3429265, 3432722, 3440006, 3467682, 3467683, 3475349, 3489248, 3493797, 3509569, 3521742, 3526245, 3526337, 3529553, 3529672, 3533982, 3542040, 3546408, 3564993, 3570687, 3570840, 3576129, 3576138, 3635067, 3646546, 3658725, 3678314, 3688406, 3695958, 3696009, 3708884, 3727517, 3728938, 3745100, 3754085, 3764388, 3768464, 3784917, 3788804, 3791099, 3798345, 3802616, 3806235, 3843436, 3846795, 3855864, 3855865, 3858487, 3862085, 3864846, 3867640, 3867641, 3874801, 3878332, 3881026, 3884523, 3891892, 3904937, 3917655

    Distribution

    US Nationwide distribution.

    Quantity

    66,633 units