RecallRadar

FDA Device recall Z-1013-2023

Baxter Electrocardiograph, ELI 380 -DCS21

On 2023-02-01 the FDA classified a Class II recall of Baxter Electrocardiograph, ELI 380 -DCS21 by Baxter Healthcare, citing one ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1013-2023
ClassificationClass II
Statusterminated
Initiated2022-10-31
Published2023-02-01
Last updated2026-09-13 11:56 UTC
CompanyBaxter Healthcare
DistributionTX

Product

Baxter Electrocardiograph, ELI 380 -DCS21

Reason

One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.

Identifiers

code_infoLot number 122420001706

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1013-2023%22

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