The FDA issued a Class I recall — the most serious kind of recall — for Baxter’s Dose IQ safety software program.

Baxter designed its Dose IQ safety software as a standalone computer-based software program that allows care providers to create a drug library of pre-programmed dosing information for specific medications, which are delivered into a person’s body in controlled amounts using the Spectrum IQ infusion pump.

The recall occurred due to a software defect that may lead to mismatched drug information in drug libraries created using version 9.0.x of the computer-based software.

According to an FDA notice, if the software’s drug identifier does not match the drug information on the pump, the drugs may be improperly configured and cause serious adverse events including delay in therapy, under-infusion or over-infusion of medication. To date, there have been 15 complaints, no injuries and no deaths reported for the issue.

Devices affected by the recall fall under the product code 35723V091 and were distributed between Feb. 1, 2018, and Jan. 1, 2019. In total, the company recalled 61 devices since initiating the recall on July 7, 2021.