Baxter Healthcare Corporation recalls SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009

Recall date

September 18, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0107-2019

FDA classification

Class II

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

NJ

Why it was recalled

If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from programming the infusion.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009