Baxter Healthcare Corporation: Medical Device Recall in 2018 - (Recall #: Z-0107-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009

Product Classification:

Class II

Date Initiated: September 18, 2018

Date Posted: October 24, 2018

Recall Number: Z-0107-2019

Event ID: 81158

Reason for Recall:

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.

Status: Terminated

Product Quantity: 354 units

Code Information:

UDI 00085412610900 All Serial Numbers distributed prior to 07/09/2018

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated