BEUDAMED
    FDA Enforcement Class II Terminated

    Video Duodenoscope

    Recall: Z-1835-2016 · Reported June 8, 2016

    Enforcement

    Recall Number
    Z-1835-2016
    Event ID
    73377
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pentax Medical Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 8, 2016
    Initiation Date
    February 22, 2016
    Classification Date
    May 27, 2016
    Termination Date
    December 6, 2017
    Address
    3 Paragon Dr, N/A, Montvale, NJ, 07645-1782, United States

    Description

    Video Duodenoscope

    Reason

    Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.

    Code Info

    A110021, A110022, A110023, A110024, A110025, A110026, A110027, A110028, A110029, A110030, A110031, A110032, A110033, A110034, A110035, A110036, A110037, A110038, A110039, A110043, A110046, A110051, A110055, A110056, A110057, A110058, A110059, A110060, A110061, A110062, A110063, A110064, A110065, A110067, A110068, A110070, A110071, A110072, A110073, A110074, A110075, A110076, A110077, A110078, A110079, A110080, A110081, A110082, A110083, A110086, A110087, A110088, A110089, A110090, A110091, A110092, A110095, A110098, A110099, A110100, A110114, A110115, A110116, A110117, A110118, A110121, A110122, A110127, A110128, A110129, A110130, A110131, A110132, A110133, A110134, A110135, A110136, A110137, A110138, A110140, A110142, A110143, A110150, A110152, A110156, A110157, A110158, A110159, A110160, A110162, A110163, A110164, A110165, A110166, A110167, A110168, A110169, A110170, A110173, A110174, A110177, A110178, A110179, A110180, A110182, A110183, A110190, A110191, A110192, A110193, A110194, A110203, A110204, A110206, A110207, A110208, A110209, A110210, A110211, A110213, A110214, A110215, A110216, A110217, A110218, A110229, A110230, A110231, A110232, A110233, A110234, A110235, A110236, A110237, A110243, A110244, A110246, A110247, A110248, A110249, A110250, A110251, A110252, A110258, A110259, A110260, A110268, A110269, A110272, A110273, A110274, A110275, A110276, A110277, A110278, A110279, A110280, A110281, A110283, A110284, A110285, A110287, A110288, A110289, A110290, A110293, A110297, A110301, A110302, A110304, A110305, A110306, A110307, A110308, A110316, A110317, A110318, A110319, A110320, A110321, A110322, A110323, A110324, A110325, A110326, A110327, A110328, A110329, A110331, A110333, A110338, A110339, A110345, A110347, A110352, A110362, A110363, A110385, A110386, A110387, A110388, A110389, A110390, A110391, A110392, A110393, A110399, A110403, A110405, A110406, A110407, A110409, A110410, A110412, A110413, A110415, A110416, A110417, A110418, A110419, A110421, A110422, A110424, A110438, A110439, A110440, A110454, A110462, A110464, A110466, A110468, A110470, A110473, A110474, A110476, A110480, A110483, A110491, A110492, A110495, A110496, A110497, A110498, A110499, A110501, A110502, A110518, A110520, A110521, A110524, A110525, A110527, A110534, A110535, A110538, A110547, A110549, A110550, A110553, A110554, A110555, A110574, A110581, A110582, A110587, A110588, A110589, A110590, A110591, A110593, A110594, A110595, A110596, A110598, A110599, A110600, A110601, A110602, A110607, A110610, A110612, A110614, A110615, A110616, A110617, A110619, A110620, A110621, A110623, A110625, A110626, A110633, A110649, A110651, A110652, A110654, A110665, A110666, A110667, A110668, A110669, A110670, A110671, A110672, A110674, A110675, A110676, A110677, A110678, A110680, A110682, A110683, A110684, A110686, A110692, A110694, A110695, H110699, H110700, H110701, H110703, H110704, H110705, H110706, H110707, H110708, H110709, H110710, H110711, H110712, H110714, H110715, H110716, H110717, H110718, H110719, H110721, H110723, H110729, H110733, H110736, H110737, H110738, H110740, H110749, H110754, H110767, H110773, H110774, H110775, H110779, H110780, H110781, H110782, H110783, H110784, H110786, H110788, H110789, H110790, H110791, H110792, H110793, H110794, H110795, H110796, H110797, H110799, H110800, H110802, H110803, H110805, H110807, H110819, H110822, H110823, H110825, H110826, H110827, H110828, H110830, H110831, H110832, H110834, H110835, H110837, H110838, H110840, H110842, H110844, H110845, H110846, H110849, H110850, H110851, H110852, H110853, H110858, H110859, H110860, H110861, H110862, H110863, H110865, H110866, H110867, H110868, H110869, H110870, H110871, H110872, H110873, H110876, H110877, H110880, H110881, H110882, H110883, H110890, H110891, H110892, H110893, H110894

    Distribution

    Nationwide

    Quantity

    423 units