Baxter Healthcare Corporation: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

Recall number

Z-1254-2025

Recalling firm

Baxter Healthcare Corporation

Product

Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

Status

Open, Classified

Initiated

2025-02-05

Posted

2025-03-06

Terminated

not on file

Reason

There is the potential for missing motor mounting screws, which may have occurred during the servicing process.

Root cause

Under Investigation by firm

Action

Baxter issued an "URGENT MEDICAL DEVICE RECAL" notice to its consignees on 02/05/2025 via US Mail. The notice explained the issue, hazard involved, and requested the following actions be taken: "1. Immediately locate, isolate, and cease all use of Spectrum pumps with the affected serial numbers. The product code and serial number can be found on the bottom of the infusion pump. 2. Contact Baxter to arrange for the return of the affected pumps for inspection and reservicing as applicable. 3. If you received this communication directly from Baxter, acknowledge receipt on the enclosed reply form even if you have no remaining inventory. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 5. Please forward a copy of this communication to all departments within your institution who use the affected product. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a user-level recall of the affected product that you distributed to customers and check the associated box on the customer portal. For general questions regarding this communication, or quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-843-7867 Monday through Friday, between 7:00 am and 7:00 pm Eastern Time."

Quantity

323 units

Distribution

US: Nationwide

Lot, serial or model codes

UDI/DI 00085412610900, Serial Numbers: 3020290, 3020992, 3020996, 3021929, 3023080, 3023183, 3023537, 3023758, 3500529, 3502799, 3502864, 3510806, 3511639, 3512647, 3514801, 3516888, 3517399, 3517517, 3518558, 3519053, 3564064, 3564818, 3565462, 3565620, 3566022, 3566254, 3567145, 3567218, 3567998, 3568527, 3568922, 3570910, 3571100, 3571598, 3571972, 3573147, 3573504, 3574293, 3575033, 3575107, 3576026, 3576443, 3656732, 3657316, 3657541, 3657814, 3657821, 3657995, 3659259, 3660176, 3660244, 3662986, 3664495, 3665624, 3721608, 3721910, 3721946, 3722620, 3723725, 3724211, 3730270, 3730408, 3732309, 3732476, 3734858, 3735010, 3735261, 3735734, 3738122, 3744219, 3744455, 3746159, 3746749, 3749111, 3749929, 3764591, 3767418, 3519969, 3520138, 3520706, 3520746, 3520829, 3521120, 3521338, 3606099, 3607097, 3607681, 3608730, 3609223, 3610668, 3610820, 3611120, 3611140, 3611650, 3612298, 3612886, 3613052, 3614035, 3615599, 3615816, 3616449, 3666443, 3666451, 3667116, 3668076, 3668654, 3668851, 3669058, 3669126, 3669307, 3670942, 3671444, 3672061, 3672846, 3676099, 3677241, 3679511, 3680542, 3681596, 3681981, 3686743, 3689421, 3691453, 3691496, 3693341, 3696268, 3618354, 3619039, 3619876, 3620296, 3620427, 3620631, 3620643, 3620757, 3621068, 3621252, 3621777, 3623915, 3623963, 3624131, 3624546, 3627519, 3628177, 3630964, 3632085, 3632710, 3632830, 3633267, 3634729, 3634792, 3699321, 3699388, 3699822, 3699917, 3700350, 3700551, 3701785, 3703127, 3703425, 3703513, 3703840, 3704056, 3704228, 3705346, 3706311, 3706762, 3706856, 3707896, 3002100, 3003072, 3004069, 3006254, 3006831, 3009116, 3009918, 3011726, 3012929, 3013032, 3013567, 3014990, 3015179, 3015242, 3016501, 3018280, 3018908, 3020206, 3576448, 3576730, 3576867, 3577158, 3578268, 3578536, 3578772, 3578906, 3584933, 3587077, 3588099, 3590690, 3591061, 3591360, 3591997, 3593297, 3634941, 3635142, 3637457, 3638689, 3640189, 3642200, 3642537, 3642720, 3645079, 3645908, 3646680, 3647126, 3647441, 3647540, 3647866, 3648851, 3648878, 3650355, 3650984, 3651372, 3654108, 3655491, 3655618, 3655785, 3655938, 3656531, 3521873, 3521999, 3522038, 3522253, 3522529, 3523783, 3523984, 3524348, 3524522, 3528869, 3528966, 3529402, 3529628, 3529632, 3529636, 3529928, 3529935, 3530350, 3530787, 3531077, 3531419, 3534705, 3539485, 3539740, 3540240, 3540832, 3595222, 3598809, 3599437, 3601012, 3601382, 3602225, 3603240, 3603637, 3603686, 3603842, 3603852, 3603947, 3604716, 3605640, 3605644, 3605994, 3697496, 3697667, 3697864, 3698034, 3698139, 3698336, 3699050, 3699248, 3541085, 3542213, 3542383, 3542809, 3542839, 3543062, 3543083, 3543172, 3544259, 3546132, 3548337, 3548404, 3549047, 3552392, 3554222, 3554971, 3555901, 3555949, 3556168, 3556278, 3556819, 3556876, 3557131, 3557902, 3560245, 3562324, 3562649, 3562705, 3562975, 3616568, 3616648, 3617327, 3617431, 3617744, 3708183, 3708637, 3708695, 3709027, 3709669, 3710188, 3711475, 3714210, 3715824, 3717594, 3718985.

510(k) numbers

K230041

PMA numbers

not on file

Product code

FRN

Firm FEI

1417572

Firm city

Deerfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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