FDA recall Z-1013-2023
Baxter Healthcare Corporation · Class II · device
Product
Baxter Electrocardiograph, ELI 380 -DCS21
Reason for recall
One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.
Distribution
TX
Key facts
- Status
- Terminated
- Initiation date
- 2022-10-31
- Report date
- 2023-02-01
- Termination date
- 2025-03-06
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Deerfield, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1013-2023