Date Initiated by Firm |
November 19, 2020 |
Create Date |
December 30, 2020 |
Recall Status1 |
Terminated 3 on September 26, 2022 |
Recall Number |
Z-0756-2021 |
Recall Event ID |
86825 |
510(K)Number |
K163334
|
Product Classification |
Computer, diagnostic, pre-programmed, single-function - Product Code DXG
|
Product |
CM 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 |
Action |
The recalling firm contacted consignees via email to notify of the recall. Customers are asked to return impacted product to the recalling firm. |
Quantity in Commerce |
40 packs (5 each per pack) |
Distribution |
Worldwide distribution - US Nationwide distribution in the state of IL and the country of Kuwait. |
Total Product Life Cycle |
TPLC 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) Database |
510(K)s with Product Code = DXG and Original Applicant = LiDCO Ltd
|