Z-1487-2021 Class II Terminated

Recalled by Baxter Healthcare Corporation — Medina, NY

FDA device recall Z-1487-2021 was initiated by Baxter Healthcare Corporation on Mar 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 Jul 15, 2022). Affected quantity: 408 units.

Recall details

Product Type
Devices
Report Date
May 5, 2021
Initiation Date
Mar 19, 2021
Termination Date
Jul 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.

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1487-2021
openFDA file date
Nov 10, 2026
Loaded by RegDataLab
Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for Z-1487-2021. Report a data issue: hello@regdatalab.com.