ICU Medical, Inc. recalls icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-…

Recall date

February 21, 2019

Source

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

Recall number

Z-1093-2019

FDA classification

Class I

Brand / firm

ICU Medical, Inc.

Sold / distributed

Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.

Why it was recalled

There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.

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 ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.