Z-2110-2021 Class I Terminated
FDA device recall Z-2110-2021 was initiated by Baxter Healthcare Corporation on Jun 4, 2021 and is designated Class I. Reason for recall: System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive… The recall status is terminated (terminated Sep 25, 2024). Affected quantity: 130135 units.
Recall details
- Product Type
- Devices
- Report Date
- Aug 18, 2021
- Initiation Date
- Jun 4, 2021
- Termination Date
- Sep 25, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 130135 units
Product description
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Reason for recall
System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors.
Distribution pattern
United States (including Puerto Rico), Canada, Bahamas, Bermuda, Guyana, and Trinidad and Tobago.
Code information
All Serial Numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2110-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026