medical Class I Updated 2019-04-24

ICU Medical, Inc. recalls icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S .

Recalled Product

icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 3866759, 3872252, 3910046, 3910627
View official government recall

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