Dose IQ Safety Software used with Spectrum IQ Infusion Pump — Class I medical device recall Z-2165-2021
Terminated recall by Baxter Healthcare Corporation, reported 2021-08-18, distributed nationwide. Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interf
| Recall number | Z-2165-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2021-07-07 |
| Classified | 2021-08-11 |
| Reported by FDA | 2021-08-18 |
| Terminated | 2024-06-20 |
| Distributed | Nationwide (US) |
| Quantity | 61 units |
| Reason classes | software |
Product
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
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.
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-2165-2021. 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.