FDA recall Z-0756-2021

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 for recall

The expiration date on labeling is incorrect.

Distribution

Worldwide distribution - US Nationwide distribution in the state of IL and the country of Kuwait.

Key facts

Status

Terminated

Initiation date

2020-11-19

Report date

2021-01-06

Termination date

2022-09-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

London, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0756-2021