—#188212

Product

Dose IQ Safety Software used with Spectrum IQ Infusion Pump

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K173084
Affected lot / code info: Software version: All libraries initially created with version 9.0.x

Why it was recalled

Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump.

Root cause (FDA determination)

Software design

Action the firm took

The firm issued an Urgent Medical Device Correction notice by letter on July 7, 2021. The letter explained the issue and provided a temporary workaround which can be implemented until the new software tool is ready for distribution.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US Nationwide Distribution.

Timeline

Recall initiated: 2021-07-07
Posted by FDA: 2021-08-11
Terminated: 2024-06-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188212. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.