Recall Z-0756-2021

Lidco Ltd · initiated November 19, 2020

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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

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

Reason for recall

The expiration date on labeling is incorrect.

FDA-determined cause: Labeling mix-ups

Action taken

The recalling firm contacted consignees via email to notify of the recall. Customers are asked to return impacted product to the recalling firm.

Details

Recall number
Z-0756-2021
Initiated
November 19, 2020
Terminated
September 26, 2022
Product code
DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
Quantity
40 packs (5 each per pack)
Distribution
Worldwide distribution - US Nationwide distribution in the state of IL and the country of Kuwait.
Recalling firm
Lidco Ltd, London

Official FDA recall record