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U.S. Department of Health and Human Services

Class 2 Device Recall CM 5000101 Injectate Kit

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 Class 2 Device Recall CM 5000101 Injectate Kitsee related information
Date Initiated by FirmNovember 19, 2020
Create DateDecember 30, 2020
Recall Status1 Terminated 3 on September 26, 2022
Recall NumberZ-0756-2021
Recall Event ID 86825
510(K)NumberK163334 
Product Classification Computer, diagnostic, pre-programmed, single-function - Product Code DXG
ProductCM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set).
Code Information Model CM 50-001-01, Lot 11103786 (expiration: 04/26/2023) and Lot 11090135 (expiration: 02/2023)
Recalling Firm/
Manufacturer		 Lidco Ltd
16 Orsman Road
London United Kingdom
Manufacturer Reason
for Recall		The expiration date on labeling is incorrect.
FDA Determined
Cause 2		Labeling mix-ups
ActionThe recalling firm contacted consignees via email to notify of the recall. Customers are asked to return impacted product to the recalling firm.
Quantity in Commerce40 packs (5 each per pack)
DistributionWorldwide distribution - US Nationwide distribution in the state of IL and the country of Kuwait.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DXG
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