Recall Z-1013-2023
Baxter Healthcare Corporation · initiated October 31, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Baxter Electrocardiograph, ELI 380 -DCS21
Codes / lots: Lot number 122420001706
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.
FDA-determined cause: Process control
Action taken
The customer was contacted on 31 October 2022 to inform them of the issue and instructed not to install the device for use.
Details
- Recall number
- Z-1013-2023
- Initiated
- October 31, 2022
- Posted by FDA
- January 24, 2023
- Terminated
- March 6, 2025
- Product code
- DPS – Electrocardiograph
- Quantity
- 1 unit
- Distribution
- TX
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL