ICU Medical, Inc. recalls icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfe…

Recall date

January 3, 2019

Source

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

Recall number

Z-0805-2019

FDA classification

Class I

Brand / firm

ICU Medical, Inc.

Sold / distributed

US Distribution to states of: OH, FL, IA, CA, PA, IL, VA; and internationally to: AUSTRIA, CHINA (TAIWAN), IRELAND, ITALY and SINGAPORE.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.