FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Baxter Electrocardiograph, ELI 380 -DCS21
- Recall number
- Z-1013-2023
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Baxter Electrocardiograph, ELI 380 -DCS21
- Status
- Terminated
- Initiated
- 2022-10-31
- Posted
- 2023-01-24
- Terminated
- 2025-03-06
- Reason
- One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.
- Root cause
- Process control
- Action
- The customer was contacted on 31 October 2022 to inform them of the issue and instructed not to install the device for use.
- Quantity
- 1 unit
- Distribution
- TX
- Lot, serial or model codes
- Lot number 122420001706
- 510(k) numbers
- ["K142105"]
- PMA numbers
- not on file
- Product code
- DPS
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28