Z-1013-2023Class II

Baxter Electrocardiograph, ELI 380 -DCS21

Name: Z-1013-2023 Baxter Electrocardiograph, ELI 380 -DCS21
Creator: Baxter Healthcare Corporation
Published: 2022-10-31
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-10-31 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Baxter Electrocardiograph, ELI 380 -DCS21 on 2022-10-31. FDA classified it as Class II and gives the reason as "One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1013-2023
Classification: Class II
Status: Terminated
Initiated: 2022-10-31
Posted: 2023-01-24
Terminated: 2025-03-06
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Electrocardiograph, ELI 380 -DCS21
Product code: DPS Electrocardiograph
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 1 unit
Distribution: TX
Product codes and lots: Lot number 122420001706

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1013-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1013-2023	Class II	Terminated	Voluntary: Firm initiated	2023-02-01	2023-01-24

Product code DPS

K142105Class IIEli 380 ElectrocardiographMortara Instrument, Inc. / cleared 2014-09-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)