Z-1487-2021 Class II Terminated
FDA device recall Z-1487-2021 was initiated by Baxter Healthcare Corporation on March 19, 2021 and is designated Class II. Reason for recall: Potentially defective component in the AC power adapter which may fail over time. The recall status is terminated (terminated July 15, 2022). Affected quantity: 408 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 5, 2021
- Initiation Date
- March 19, 2021
- Termination Date
- July 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 408 units
Product Description
Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.
Reason for Recall
Potentially defective component in the AC power adapter which may fail over time.
Distribution Pattern
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.
Code Information
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.