Recalls / —

—#212493

Product

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

FDA product code

FRN — Pump, Infusion

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K230041

Affected lot / code info

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.

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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."

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern

US: Nationwide

Timeline

Recall initiated

2025-02-05

Posted by FDA

2025-03-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #212493. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.