Device product
CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set).
Z-0756-2021
Product summary
- Firm
- Lidco Ltd
- Event
- Event 86825
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 packs (5 each per pack)
- Official record key
device-enforcement:Z-0756-2021
Official wording
Reason: The expiration date on labeling is incorrect.
Code information: Model CM 50-001-01, Lot 11103786 (expiration: 04/26/2023) and Lot 11090135 (expiration: 02/2023)
Distribution pattern: Worldwide distribution - US Nationwide distribution in the state of IL and the country of Kuwait.
Derived failure modes
-
Labeling or packaging
labeling is incorrect