BEUDAMED
    FDA Recall 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 · Initiated December 4, 2019

    Recall

    Recall Number
    Z-1791-2020
    Event Number
    85398
    Firm
    Argon Medical Devices, Inc
    FEI Number
    1625425
    Product Code
    DQX
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 4, 2019
    Posted
    May 7, 2020
    Terminated
    April 1, 2024
    Address
    1445 Flat Creek Rd, Athens, TX, 75751-5002

    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.

    Action

    On 12/04/2019, the firm sent Medical Device Recall letter by email to their customer/ distributors. Customers are instructed to inspect and quarantine and return any affected product remaining at their facility utilizing the instruction on the Recall Response Form. Customers are instructed to complete the response acknowledgement form included with the letter and return by fax, mail or email as soon as possible. Customers were also instructed to pass the notice on to all those who need to be aware within their organization or to any organization to which the potentially affected devices have been transferred.

    Distribution

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

    Quantity

    1690 units