FDA-Device2024-12-18Class II

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.

ICU Medical, Inc.
Hazard

Due to finished goods incorrectly packaged and labeled.

Sold states
Worldwide - U.S. Nationwide distribution in the state of IL and the country of Canada.
Affected count
6000 units
Manufactured in
951 Calle Amanecer, San Clemente, CA, United States
Products
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.

Official notice

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

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