BEUDAMED
    FDA Enforcement Class II Terminated

    Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.

    Recall: Z-1487-2021 · Reported May 5, 2021

    Enforcement

    Recall Number
    Z-1487-2021
    Event ID
    87568
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    May 5, 2021
    Initiation Date
    March 19, 2021
    Classification Date
    April 23, 2021
    Termination Date
    July 15, 2022
    Address
    711 Park Ave, N/A, Medina, NY, 14103-1036, United States

    Description

    Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.

    Reason

    Potentially defective component in the AC power adapter which may fail over time.

    Code Info

    Product Code: 3570009 Serial Numbers: 3008222, 3539596, 3546215, 3586366, 3619652, 3622541, 3623709, 3624381, 3624740, 3625247, 3011477, 3539777, 3547110, 3586582, 3619759, 3622688, 3623721, 3624383, 3624744, 3625266, 3012363, 3540327, 3547708, 3586798, 3619767, 3622691, 3623728, 3624393, 3624749, 3625275, 3013708, 3540486, 3548756, 3587371, 3620063, 3622721, 3623737, 3624396, 3624761, 3625300, 3014132, 3541062, 3549098, 3587774, 3620333, 3622773, 3623754, 3624409, 3624763, 3625308, 3014459, 3541163, 3552089, 3588483, 3620532, 3622779, 3623789, 3624414, 3624777, 3625314, 3500621, 3541326, 3553030, 3589274, 3620606, 3622791, 3623801, 3624415, 3624784, 3625370, 3500772, 3541365, 3554960, 3590805, 3620620, 3622849, 3623843, 3624446, 3624805, 3625422, 3502812, 3541546, 3557201, 3597269, 3620626, 3622888, 3623873, 3624449, 3624818, 3625437, 3522442, 3541581, 3560533, 3598374, 3620699, 3622889, 3623877, 3624473, 3624824, 3625443, 3525471, 3541732, 3560780, 3599028, 3620766, 3623048, 3623878, 3624493, 3624825, 3625512, 3526276, 3541857, 3562368, 3600400, 3620769, 3623157, 3623886, 3624497, 3624826, 3625548, 3526801, 3541923, 3563542, 3601482, 3620775, 3623241, 3623895, 3624498, 3624827, 3625634, 3526869, 3541932, 3564532, 3601498, 3620790, 3623244, 3623921, 3624539, 3624828, 3625648, 3527443, 3541971, 3566208, 3601772, 3620887, 3623295, 3623962, 3624541, 3624830, 3625684, 3527832, 3542101, 3566535, 3602192, 3620905, 3623349, 3623985, 3624553, 3624835, 3625685, 3528039, 3542226, 3566790, 3602246, 3621090, 3623416, 3623991, 3624567, 3624838, 3625694, 3528084, 3542278, 3566871, 3607943, 3621234, 3623420, 3624034, 3624572, 3624839, 3625695, 3528271, 3542683, 3569103, 3608133, 3621315, 3623434, 3624069, 3624573, 3624853, 3625698, 3528426, 3542739, 3571487, 3609850, 3621351, 3623441, 3624155, 3624590, 3624905, 3625801, 3528462, 3543043, 3572131, 3609928, 3621354, 3623444, 3624162, 3624591, 3624924, 3625804, 3528535, 3543442, 3572541, 3610434, 3621459, 3623447, 3624173, 3624597, 3624925, 3625805, 3528601, 3543477, 3572696, 3610714, 3621534, 3623452, 3624185, 3624622, 3624930, 3625831, 3530776, 3543509, 3572824, 3611054, 3621591, 3623455, 3624214, 3624623, 3624934, 3625836, 3530964, 3543792, 3572909, 3611702, 3621611, 3623460, 3624221, 3624624, 3624937, 3625913, 3531978, 3543909, 3573095, 3612451, 3621684, 3623493, 3624230, 3624629, 3624966, 3625915, 3532405, 3544169, 3573194, 3614169, 3621705, 3623524, 3624243, 3624639, 3624968, 3625918, 3533275, 3544200, 3573272, 3614468, 3621786, 3623576, 3624252, 3624658, 3624971, 3625921, 3536232, 3544466, 3573666, 3616985, 3621848, 3623584, 3624259, 3624660, 3624982, 3625981, 3537657, 3544530, 3573892, 3617094, 3622007, 3623595, 3624280, 3624661, 3625003, 3626030, 3538453, 3544540, 3573916, 3617407, 3622011, 3623616, 3624283, 3624670, 3625004, 3626032, 3538557, 3544657, 3574481, 3617538, 3622077, 3623636, 3624288, 3624678, 3625025, 3626116, 3538693, 3544745, 3575642, 3617745, 3622086, 3623647, 3624290, 3624700, 3625044, 3626198, 3538779, 3544805, 3575858, 3617883, 3622133, 3623649, 3624297, 3624701, 3625115, 3626232, 3538840, 3544914, 3577824, 3618471, 3622146, 3623653, 3624303, 3624719, 3625132, 3626252, 3538847, 3545023, 3577991, 3618800, 3622148, 3623657, 3624306, 3624721, 3625156, 3626257, 3538867, 3545037, 3578563, 3618934, 3622159, 3623659, 3624339, 3624724, 3625158, 3626515, 3539013, 3545101, 3578574, 3618954, 3622201, 3623665, 3624349, 3624727, 3625186, 3628102, 3539331, 3545730, 3578811, 3619059, 3622364, 3623668, 3624358, 3624729, 3625188, 3629743, 3539375, 3545967, 3579301, 3619592, 3622429, 3623669, 3624379, 3624735, 3625234, 3539423, 3546068, 3585654, 3619625, 3622450, 3623691, 3624380, 3624736, 3625240.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CT, FL, IA, IN, LA, MA, MD, ME, MN, MO, MS, MT, NC, NJ, NY, OH, PA, RI, SC, TN, TX and the country of Puerto Rico.

    Quantity

    408 units