Baxter Electrocardiograph, ELI 380 -DCS21
FDA device recall Z-1013-2023 · posted 2023-01-24 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DPS
- Quantity affected
- 1 unit
- Distribution
- TX
- Date initiated
- 2022-10-31
- Date posted
- 2023-01-24
- Date terminated
- 2025-03-06
- Location
- Deerfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELI 380 ELECTROCARDIOGRAPH (K142105) | Mortara Instrument, Inc. | 2014-09-05 |