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Terminated

Baxter Electrocardiograph, ELI 380 -DCS21

FDA Recall Z-1013-2023 · Posted 2023-01-24

Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeDPS
Date Initiated2022-10-31
Date Terminated2025-03-06
Product Quantity1 unit

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.

Firm Action

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

Distribution Pattern

TX

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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