FDA Recall
Terminated
CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set).
Recall: Z-0756-2021
·
Initiated November 19, 2020
Recall
- Recall Number
- Z-0756-2021
- Event Number
- 86825
- Firm
- Lidco Ltd 16 Orsman Road London United Kingdom
- FEI Number
- 3001139253
- Product Code
- DXG
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- November 19, 2020
- Terminated
- September 26, 2022
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
The expiration date on labeling is incorrect.
Action
The recalling firm contacted consignees via email to notify of the recall. Customers are asked to return impacted product to the recalling firm.
Distribution
Worldwide distribution - US Nationwide distribution in the state of IL and the country of Kuwait.
Quantity
40 packs (5 each per pack)