Exact FDA event identifier

Event 91388

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: October 31, 2022
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Baxter Healthcare Corporation

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Baxter Electrocardiograph, ELI 380 -DCS21

Z-1013-2023

Recall number: Z-1013-2023
Initiated: October 31, 2022
Classification: Class II
Status: Terminated
Recalling firm: Baxter Healthcare Corporation
Quantity: 1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot number 122420001706

Distribution pattern

TX