BEUDAMED
    FDA Enforcement Class I Terminated

    Langston Dual Lumen Catheter.

    Recall: Z-0111-2021 · Reported October 28, 2020

    Enforcement

    Recall Number
    Z-0111-2021
    Event ID
    86433
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vascular Solutions, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 28, 2020
    Initiation Date
    August 31, 2020
    Classification Date
    October 20, 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.

    Reason

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

    Code Info

    Model Number: 5540, UDI, 10841156100513, Lots 643376, 633647, 639516, 645032, 649315, 650991, 656191, 658151, 659443, 660590, 666438, 670586, 672660, 635207, 636898, 643051, 644573, 645360, 645482, 648481, 649729, 650018, 650873, 651457, 653053, 655645, 655738, 657627, 658250, 658824, 659122, 659217, 660910, 661139, 663039, 663344, 665098, 665099, 666559, 668703, 671743, 671948, 672894, 633211, 635208, 635542, 636901, 637832, 644015, 646106, 649078, 650765, 654190, 657517, 657680, 660717, 662903, 663138, 665303, 667164, 669190, 647786, 671427, 634423, 634247, 648043, 648963, 651920, 653863, 660823, 662493, 661257, 650369, 638953, 669199, 658438, 668701, 636284, 640938, 641222, 641543, 641679, 642031, 650023, 654010, 655128, 657030, 660075, 663281, 663790, 663854, 635805, 659362, 668303, 666966, 632018, 635209, 643835, 645118, 646247, 647482, 649456, 652176, 653319, 656554, 659630, 661863, 662824, 665234, 669602, 647370, 648337, 672813, 664087, 657243, 652097, 668095, 636471, 640676, 642373, 642520, 644650, 654890, 655460, 657866, 658018, 661474, 662053, 662133, 664449, 667465, 668934, 670503, 672130, 663791, 635280, 669402, 632020, 638198, 639892, 640034, 648603, 653565, 654889, 658984, 662642, 671202, 643542, 645481, 672349, 635541, 661707, 666332, 670144, 654514, 654657, 671004, 671633,637388,645031, 646641, 650606, 670299, 642928, 670865, 639414, 642178, 646110, 651524, 660199, 668094, 669591, 641060, 647014, 651163, 655869, 656727 ,647697, 635861, 640459, 666067, 667936, 632019, 638323, 643874, 646108, 648210, 649584, 654340, 658541, 664236, 633929, 646640, 653443, 668305, 668771, 655287, 662265, 637384, 651829, 669737, 648780, 652777, 653776, 658671, 667832, 637945, 651278, 652628, 660288, 667151, 656801, 646879, 650560, 652459, 659855, 660397, 667835, 636709, 647206, 673021, 649315.

    Distribution

    Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL ,GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,NM ,NV ,NY ,OH ,OK,OR, PA ,PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. International Distribution: Austria, Australia, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Oman, Poland, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and United Kingdom.

    Quantity

    89,121 units