CareFusion—SmartSite Needle-Free Connectors: Disconnection from Female Luer May Be Problematic

February 5, 2014 | Strategic Insights for Health System


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In a January 22, 2014, Urgent Medical Device Recall Notification letter submitted by an ECRI Institute member hospital, CareFusion states that the connectors below may unintendedly disconnect from a female Luer and may be difficult to disconnect or fail to disconnect from a female Luer once attached. CareFusion also states that leakage may be observed if the connector disconnects from the female Luer during infusion. Disconnection of the line could result in a delay of infusion, interruption of infusion, underinfusion, or air entering the fluid path, and may necessitate line replacement. The inability to disconnect may delay or interrupt infusion. CareFusion states that it has received no reports of serious injuries or death related to this problem. CareFusion also states that this problem...

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