Recall Z-1013-2023— Baxter Healthcare Corporation

Name: FDA recall Z-1013-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-31

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2022-10-31, terminated 2025-03-06. It names one FDA 510(k) clearance: K142105. 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..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2022-10-31
Terminated: 2025-03-06
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K142105 — ELI 380 ELECTROCARDIOGRAPHMortara Instrument, Inc.·cleared 2014-09-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Baxter Electrocardiograph, ELI 380 -DCS21

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.