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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter

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  Class 2 Device Recall Baxter see related information
Date Initiated by Firm October 31, 2022
Date Posted January 24, 2023
Recall Status1 Completed
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 2		 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.
510(K) Database 510(K)s with Product Code = DPS and Original Applicant = MORTARA INSTRUMENT, INC
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