ICU Medical, Inc. recalls icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The Ch

Recalled April 24, 2019 · FDA recall Z-1096-2019 · ICU Medical

Hazard

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. · FDA Class I

Units

160775 devices

Sold at

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

Description

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.

Product

icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. 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. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

Manufacturer(s)

ICU Medical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →