FDA Medical Device Recalls (openFDA)
Lidco Ltd: CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set).
- Recall number
- Z-0756-2021
- Recalling firm
- Lidco Ltd
- Product
- CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set).
- Status
- Terminated
- Initiated
- 2020-11-19
- Posted
- not on file
- Terminated
- 2022-09-26
- Reason
- The expiration date on labeling is incorrect.
- Root cause
- 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
- 40 packs (5 each per pack)
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of IL and the country of Kuwait.
- Lot, serial or model codes
- Model CM 50-001-01, Lot 11103786 (expiration: 04/26/2023) and Lot 11090135 (expiration: 02/2023)
- 510(k) numbers
- ["K163334"]
- PMA numbers
- not on file
- Product code
- DXG
- Firm FEI
- 3001139253
- Firm city
- London
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28