Z-1013-2023 Class II Terminated
FDA device recall Z-1013-2023 was initiated by Baxter Healthcare Corporation on Oct 31, 2022 and is designated Class II. 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. The recall status is terminated (terminated Mar 6, 2025). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 1, 2023
- Initiation Date
- Oct 31, 2022
- Termination Date
- Mar 6, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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.
Distribution Pattern
TX
Code Information
Lot number 122420001706
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1013-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026