BEUDAMED
    FDA Enforcement Class I Terminated

    Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies

    Recall: Z-1747-2020 · Reported May 6, 2020

    Enforcement

    Recall Number
    Z-1747-2020
    Event ID
    85350
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vascular Solutions, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2020
    Initiation Date
    March 16, 2020
    Classification Date
    April 27, 2020
    Termination Date
    June 18, 2024
    Address
    6420 Sycamore Ln N, N/A, Maple Grove, MN, 55369-6013, United States

    Description

    Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies

    Reason

    The inner lumen of the Langston catheter may separate from the hub during pressure injection.

    Code Info

    Model 5540; UDI 10841156100513; Lots 651278, 651457, 651920, 652097, 652176, 652459, 652628, 652777, 653053, 653319, 653443, 653565, 653776, 653863, 654010, 654190, 654340, 654514, 654657, 654889, 654890, 655128, 655287, 655460, 655465, 655738, 655869, 656191, 656533, 656554, 656727, 656801, 657030, 657243, 657517, 657627, 657680, 657866, 658018, 658151, 658250, 658438, 658541, 658671, 658824, 658984, 659122, 659217, 659362, 659443, 659630, 659855, 660075, 660199, 660288, 660397, 660590, 660717, 660823, 660910, 661139, 661257, 661474, 662824

    Distribution

    Worldwide distribution. US nationwide, Austria, Australia, Belgium, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Slovakia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

    Quantity

    30,877 units