CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set).
FDA Recall Z-0756-2021 · Posted None
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Recalling FirmLidco Ltd
Recall StatusTerminated
Product CodeDXG
Date Initiated2020-11-19
Date Terminated2022-09-26
Product Quantity40 packs (5 each per pack)
Reason for Recall
The expiration date on labeling is incorrect.
Firm Action
The recalling firm contacted consignees via email to notify of the recall. Customers are asked to return impacted product to the recalling firm.
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the state of IL and the country of Kuwait.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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