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Z-0756-2021 Class II Terminated

Recalled by Lidco Ltd — London, N/A

FDA device recall Z-0756-2021 was initiated by Lidco Ltd on November 19, 2020 and is designated Class II. Reason for recall: The expiration date on labeling is incorrect. The recall status is terminated (terminated September 26, 2022). Affected quantity: 40 packs (5 each per pack).

Recall Details

Product Type: Devices
Report Date: January 6, 2021
Initiation Date: November 19, 2020
Termination Date: September 26, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 40 packs (5 each per pack)

Product Description

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

Reason for Recall

The expiration date on labeling is incorrect.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the state of IL and the country of Kuwait.

Code Information

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