FDAClass IMarch 12, 2025

Baxter Spectrum IQ Infusion System with Dose IQ Safety recall

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

Why was Baxter Spectrum IQ Infusion System with Dose IQ Safety recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Recalling firm
Baxter Healthcare Corporation
Quantity
323 units
Distribution
US: Nationwide
Recall date
March 12, 2025
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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