BEUDAMED
    FDA Enforcement Class I Terminated

    0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO

    Recall: Z-1791-2020 · Reported May 13, 2020

    Enforcement

    Recall Number
    Z-1791-2020
    Event ID
    85398
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Argon Medical Devices, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 13, 2020
    Initiation Date
    December 4, 2019
    Classification Date
    May 7, 2020
    Termination Date
    April 1, 2024
    Address
    1445 Flat Creek Rd, N/A, Athens, TX, 75751-5002, United States

    Description

    0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO

    Reason

    The stiffness of the soft end of the guidewire caused tissue perforation.

    Code Info

    Guidewire Model 114135080; LOT numbers: 11235895, 11234476, 11237014, and 11240602.

    Distribution

    No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England

    Quantity

    1690 units