Recalls / —

—#210440

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

00085412610900, Serial Numbers: 3796578, 3797382, 3797464, 3797578, 3797728, 3797733, 3798019, 3798200

Why it was recalled

The door on the Spectrum IQ Infusion pump may not be able to fully close.

Root cause (FDA determination)

Process control

Action the firm took

Baxter Healthcare notified its consignees on 10/03 and 04/2024 via telephone. The call included information regarding the problem with the device, risk to health, and requested the affected units be removed from service pending inspection. On-site inspections to assess for impact and offer replacement, were scheduled.

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern

GA, ID

Timeline

Recall initiated

2024-10-02

Posted by FDA

2024-11-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #210440. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.