FDA recall Z-2530-2024
Baxter Healthcare Corporation · Class II · device
Product
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Reason for recall
Improperly performed testing prior to release
Distribution
US Nationwide distribution in the state of Florida.
Key facts
- Status
- Ongoing
- Initiation date
- 2024-06-14
- Report date
- 2024-08-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Deerfield, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2530-2024