Z-2165-2021 Class I Terminated
FDA device recall Z-2165-2021 was initiated by Baxter Healthcare Corporation on Jul 7, 2021 and is designated Class I. 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. The recall status is terminated (terminated Jun 20, 2024). Affected quantity: 61 units.
Recall details
- Product Type
- Devices
- Report Date
- Aug 18, 2021
- Initiation Date
- Jul 7, 2021
- Termination Date
- Jun 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61 units
Product description
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.
Distribution pattern
US Nationwide Distribution.
Code information
Software version: All libraries initially created with version 9.0.x
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2165-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026