Z-0756-2021Class II

CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor -

Name: Z-0756-2021 CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor -
Creator: Lidco Ltd
Published: 2020-11-19
License: https://open.fda.gov/license/

Lidco Ltd / initiated 2020-11-19 / Terminated / root cause: labeling and UDI

FDA source

Lidco Ltd began a recall of CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative... on 2020-11-19. FDA classified it as Class II and gives the reason as "The expiration date on labeling is incorrect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0756-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-19
Posted: 2020-12-30
Terminated: 2022-09-26
Recalling firm: Lidco Ltd
Product: CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set).
Product code: DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Reason for recall: The expiration date on labeling is incorrect.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The recalling firm contacted consignees via email to notify of the recall. Customers are asked to return impacted product to the recalling firm.
Quantity in commerce: 40 packs (5 each per pack)
Distribution: Worldwide distribution - US Nationwide distribution in the state of IL and the country of Kuwait.
Product codes and lots: Model CM 50-001-01, Lot 11103786 (expiration: 04/26/2023) and Lot 11090135 (expiration: 02/2023)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0756-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0756-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-06	2020-12-30

Product code DXG

K163334Class IILiDCOunity v2 Hemodynamic MonitorLidco, Ltd. / cleared 2017-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)