SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE — Class II medical device recall Z-0107-2019
Terminated recall by Baxter Healthcare Corporation, reported 2018-10-24, distributed in NJ. If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Libra
| Recall number | Z-0107-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Medina, NY, United States |
| Recall initiated | 2018-09-18 |
| Classified | 2018-10-12 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2020-08-19 |
| Distributed | NJ |
| Quantity | 354 units |
| UPC / GTIN / UDI-DI | 00085412610900 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0107-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.