Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

icumedical ChemoLock Vial Spike Recalled by ICU Medical, Inc. Due to There is a potential for one lot of...

Date: January 3, 2019
Company: ICU Medical, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ICU Medical, Inc. directly.

Affected Products

icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system.

Quantity: 2050 units

Why Was This Recalled?

There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate

Where Was This Sold?

This product was distributed to 7 states: CA, FL, IL, IA, OH, PA, VA

Affected (7 states)Not affected

About ICU Medical, Inc.

ICU Medical, Inc. has 592 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report