—#197603

Product

Baxter Electrocardiograph, ELI 380 -DCS21

FDA product code: DPS — Electrocardiograph
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K142105
Affected lot / code info: Lot number 122420001706

Why it was recalled

One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.

Root cause (FDA determination)

Process control

Action the firm took

The customer was contacted on 31 October 2022 to inform them of the issue and instructed not to install the device for use.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: TX

Timeline

Recall initiated: 2022-10-31
Posted by FDA: 2023-01-24
Terminated: 2025-03-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197603. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.