Vyaire Medical—​CareFusion Patient Breathing Circuits: May Lack Proper FDA Clearance

March 8, 2017 | Strategic Insights for Health System


​ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

In a January 30, 2017, Important Recall Communication letter submitted by an ECRI Institute member hospital, Vyaire Medical states that the above patient breathing circuits lack proper regulatory clearance from FDA. Vyaire Medical also states that this lack of regulatory clearance does not pose any additional hazards to health care workers, providers, or patients beyond that associated with similarly cleared LTV and ReVel ventilator patient circuits on the market. Vyaire Medical further states that the Carefusion is discontinuing production of the above patient circuits. Vyaire Medical has not confirmed the...

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