medical Class II Updated 2020-10-28

ICU Medical, Inc. recalls 6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-

Recalled Product

6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros Red Cap;1 unit per pouch, 50 pouches per case. UDI:(01)10887709098878(17)241201(30)50(10)4493149. 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

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number:4493149.
View official government recall

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