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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Hazard
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
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