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Recall Observatory FDA recall evidence

Device product

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

Z-0756-2021

November 19, 2020

Class II

Product summary

Firm
Lidco Ltd
Event
Event 86825
Status
Terminated
Classification
Class II
Quantity
40 packs (5 each per pack)
Official record key
device-enforcement:Z-0756-2021

Official wording

Reason: The expiration date on labeling is incorrect.

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

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labeling is incorrect