FDA recall Z-2165-2021

Baxter Healthcare Corporation · Class I · device

Product

Dose IQ Safety Software used with Spectrum IQ Infusion Pump

Reason for recall

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.

Distribution

US Nationwide Distribution.

Key facts

Status: Terminated
Initiation date: 2021-07-07
Report date: 2021-08-18
Termination date: 2024-06-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2165-2021