Baxter Healthcare Corporation: Medical Device Recall in 2021 - (Recall #: Z-2165-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Dose IQ Safety Software used with Spectrum IQ Infusion Pump

Product Classification:

Class I

Date Initiated: July 7, 2021

Date Posted: August 18, 2021

Recall Number: Z-2165-2021

Event ID: 88246

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.

Status: Terminated

Product Quantity: 61 units

Code Information:

Software version: All libraries initially created with version 9.0.x

Distribution Pattern:

US Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated