Recall Z-0756-2021— Lidco Ltd

Name: FDA recall Z-0756-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-19

Class II · Terminated

Class II FDA medical device recall by Lidco Ltd, initiated 2020-11-19, terminated 2022-09-26. It names one FDA 510(k) clearance: K163334. Product: CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set).. Reason: The expiration date on labeling is incorrect..

Recalling firm: Lidco Ltd
Classification: Class II
Status: Terminated
Initiated: 2020-11-19
Terminated: 2022-09-26
Firm location: London, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K163334 — LiDCOunity v2 Hemodynamic MonitorLidco, Ltd.·cleared 2017-06-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

The expiration date on labeling is incorrect.

Data sourced from openFDA. This site is unofficial and independent of the FDA.