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FDAFebruary 21, 2019device

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 v...

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

icu medicalicu

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 v... — Recall Details · AllClear