Baxter ELI 380 Electrocardiograph Recalled After Misdirected Shipment
Baxter recalls one ELI 380 electrocardiograph that was shipped to a customer in Texas by mistake on 26 October 2022. The device was intended for a pilot program only.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA recall for a misdirected shipment with no reported injuries, illnesses, or described safety hazards. The concern is administrative—the device reaching an unintended customer—rather than a product defect, making this a moderate-level voluntary precautionary recall.
Plain-English summary
Baxter Healthcare Corporation is recalling one model ELI 380 electrocardiograph that was misdirected and shipped to a customer in Texas on 26 October 2022. The device carries lot number 122420001706 and was intended to be used only for a pilot program.
The device should not have been distributed to the customer who received it. This is a Class II FDA recall. Persons who received this ELI 380 unit should contact Baxter Healthcare Corporation.
The recalled product
- Product
- Baxter Electrocardiograph, ELI 380 -DCS21
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number 122420001706
Distribution
Distributed in 1 state:
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