Class 2 Device Recall Baxter

• Date Initiated by Firm: October 31, 2022
• Date Posted: January 24, 2023
• Recall Status: Terminated on March 06, 2025
• Recall Number: Z-1013-2023
• Recall Event ID: 91388
• 510(K)Number: K142105
• Product Classification: Electrocardiograph - Product Code DPS
• Product: Baxter Electrocardiograph, ELI 380 -DCS21
• Code Information: Lot number 122420001706
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer 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.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DPS