# FDA recall Z-0107-2019

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2018-09-18.

## Product

SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009

## 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.

## Distribution

NJ

## Key facts

- **Recall number:** Z-0107-2019
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-18
- **Report date:** 2018-10-24
- **Termination date:** 2020-08-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Medina, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0107-2019

## Citation

> AI Analytics. FDA recall Z-0107-2019. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-0107-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*