FDAClass IIJanuary 6, 2021

CM 50-001-01 Injectate Kit recall: Labeling Error

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

Why was CM 50-001-01 Injectate Kit recalled?

The expiration date on labeling is incorrect.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube…
Recalling firm
Lidco Ltd
Quantity
40 packs (5 each per pack)
Distribution
Worldwide distribution - US Nationwide distribution in the state of IL and the country of Kuwait.
Recall date
January 6, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls