Class II

Medical Device Recall: 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

ICU Medical, Inc. · November 6, 2024

Reason for Recall

Due to finished goods incorrectly packaged and labeled.

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.

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

6000 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0652-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.