BEUDAMED
    FDA Enforcement Class II Ongoing

    BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers

    Recall: Z-1892-2025 · Reported June 11, 2025

    Enforcement

    Recall Number
    Z-1892-2025
    Event ID
    96814
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Civco Medical Instruments Co. Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 11, 2025
    Initiation Date
    May 1, 2025
    Classification Date
    May 30, 2025
    Address
    102 1st St S, N/A, Kalona, IA, 52247-9589, United States

    Description

    BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers

    Reason

    During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.

    Code Info

    UDI-DI: 00841436120050; Lot Numbers: A174424, A176855, A177208, A182744, A184023, A185336, A185337, A186904, A189734, A190489, A193623, A194755, A198716, A198795, A199940, A200430, A202208, A203169, A203201, A203520, A205457, A207901, A208740, A211619, A212291, A213027, A215531, A216885, A217412, A220102, A221365, A221925, A225145, A226800, A228446, A228778, A229092, A229898, A230045, A230054, A230549, A230581, A231101, A231810, A232903, A233075, A233535, A236538, A238767, A239339, A239355, A240873, A240931, A241445, A242018, A242161, A243263, A243264, A245342, A245527, A246173, A248520, A248572, A250325, A252513, A252842, A254080, A254081, A254900, A254955, A255332, A257534, A258150, A258926, A260607

    Distribution

    OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and Denmark

    Quantity

    506 boxes