Z-1487-2021Class II

Spectrum IQ - Infusion Pump -

Name: Z-1487-2021 Spectrum IQ - Infusion Pump -
Creator: Baxter Healthcare Corporation
Published: 2021-03-19
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2021-03-19 / Terminated / root cause: design

FDA source

Baxter Healthcare Corporation began a recall of Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids on 2021-03-19. FDA classified it as Class II and gives the reason as "Potentially defective component in the AC power adapter which may fail over time". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1487-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-19
Posted: 2021-04-23
Terminated: 2022-07-15
Recalling firm: Baxter Healthcare Corporation
Product: Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.
Product code: FRN Pump, Infusion
Reason for recall: Potentially defective component in the AC power adapter which may fail over time.
Root cause tag: design
FDA root cause: Device Design
Action: On 3/19/2020 the firm sent a letter to its customers with the following instructions: 1. Operators may continue to use the Spectrum IQ Infusion Pumps until the correction is completed. If using an impacted pump to infuse critical medication such as vaso-active medications, ensure there is a back-up pump available in case the power adapter fails. 2. A local Baxter service representative will contact your facility to provide a list of affected serial numbers at your facility and to coordinate power adapter replacement. Your facility will be receiving this power adapter from Baxter at no charge. 3. Upon receipt of the new power adapters, refer to the Spectrum IQ Installation and Maintenance Manual (41019v900 Rev F, Section 11.2) for instructions on how to remove and replace the power adapter on the impacted pumps. The manual can be found on Baxters Technical Service Portal at https://service.baxter.com. 4. After the installation of the new power adapters, please return the original power adapters to Baxter using the packaging from the replacement power adapter and the provided return label. 5. If you received this notification directly from Baxter, complete the enclosed Baxter Customer Reply Form and return it to Baxter by e-mailing it to [email protected]. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. If you do not return the customer reply form, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 6. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. 7. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 8. If you are a de
Quantity in commerce: 408 units
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1487-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1487-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-23

Product code FRN

K173084Class IISpectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation / cleared 2018-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)