September 2014

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CareFusion EnVe and ReVel Ventilators: Class 1 Recall

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Sit and Slim II: Public Notification

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ICU Medical ConMed Stat2 Flow Controller: Class 1 Recall

[Posted 10/10/2014] AUDIENCE: Risk Manager, Biomedical Engineering ISSUE: FDA notified health professionals and their medical care organizations of a Class 1 recall of the Stat2 Flow Controller because it was assembled with the wrong internal component. The Flow Controller may deliver fluid at a much higher flow rate than what is set. Use of the…