Exact FDA event identifier

Event 86825

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

Open FDA event record

Event summary

Timeline bucket: November 19, 2020
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Lidco Ltd

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

CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set).

Z-0756-2021

Recall number: Z-0756-2021
Initiated: November 19, 2020
Classification: Class II
Status: Terminated
Recalling firm: Lidco Ltd
Quantity: 40 packs (5 each per pack)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

labeling is incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The expiration date on labeling is incorrect.

Code information

Model CM 50-001-01, Lot 11103786 (expiration: 04/26/2023) and Lot 11090135 (expiration: 02/2023)

Distribution pattern

Worldwide distribution - US Nationwide distribution in the state of IL and the country of Kuwait.