FDA recall Z-0652-2025

ICU Medical, Inc. · Class II · device

Product

ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

Reason for recall

Due to finished goods incorrectly packaged and labeled.

Distribution

Worldwide - U.S. Nationwide distribution in the state of IL and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2024-11-06
Report date
2024-12-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Clemente, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0652-2025