Medical device recalls Moderate risk

Lidco Ltd recalls CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium d…

Recall date
November 19, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0756-2021
FDA classification
Class II
Brand / firm
Lidco Ltd
Sold / distributed
Worldwide distribution - US Nationwide distribution in the state of IL and the country of Kuwait.

Why it was recalled

The expiration date on labeling is incorrect.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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