ICU Medical, Inc. recalls ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental…

Recall date

November 6, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0652-2025

FDA classification

Class II

Brand / firm

ICU Medical, Inc.

Sold / distributed

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

Why it was recalled

Due to finished goods incorrectly packaged and labeled.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.