The Recall Desk
ModerateFDA (Devices)·Z-0756-2021·Announced 2021-01-06

Lidco CM 50-001-01 Injectate Kit Recalled for Incorrect Expiration Date

Lidco Ltd is recalling specific lots of the CM 50-001-01 Injectate Kit because the expiration date on the labeling is incorrect.

What this means for you

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: The recall is for a labeling error (incorrect expiration date) without reported injuries or illnesses, which aligns with the rubric for minor labeling errors and low-risk issues.

Plain-English summary

Lidco Ltd is recalling the CM 50-001-01 Injectate Kit, an accessory device intended to administer lithium dilution indicator for the LiDCOunity v2 Monitor. The recall affects 40 packs (5 each per pack) of Model CM 50-001-01, specifically Lot 11103786 (expiration: 04/26/2023) and Lot 11090135 (expiration: 02/2023).

The reason for the recall is that the expiration date on the labeling is incorrect. The agency has classified this as a Class II recall.

The product was distributed worldwide, including nationwide distribution in the United States (specifically the state of IL) and in Kuwait. Users should check their inventory for the affected lot numbers and stop using the product if it matches the recalled lots.

The recalled product

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

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 (2)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: