PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: December 18, 2024 Initiated: November 6, 2024 #Z-0652-2025

Product Description

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.

Details

Recalling Firm
ICU Medical, Inc.
Units Affected
6000 units
Distribution
Worldwide - U.S. Nationwide distribution in the state of IL and the country of Canada.
Location
San Clemente, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by ICU Medical, Inc.. Units affected: 6000 units.
Why was this product recalled?
Due to finished goods incorrectly packaged and labeled.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 18, 2024. Severity: Moderate. Recall number: Z-0652-2025.