Recall Z-0652-2025— ICU Medical, Inc.

Name: FDA recall Z-0652-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-06

Class II · Ongoing

Class II FDA medical device recall by ICU Medical, Inc., initiated 2024-11-06. It names one FDA 510(k) clearance: K131549. 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: Due to finished goods incorrectly packaged and labeled..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-11-06
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K131549 — CHEMOLOCK, CHEMOLOCK PORTIcu Medical, Inc.·cleared 2013-07-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.