Draeger medical recalls breathing circuits and anesthesia sets

https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm629799.htm

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death

Recalled Product: Draeger Medical, Inc. VentStar and ID Breathing Circuits and Anesthesia Sets

· Model/Item Numbers:

· MP00349, MP00350, MP00351, MP00352, MP00361, MP00374 (VentStar Circuits and Anesthesia Sets)

· MP01341, MP01348, MP01350 (ID Circuits and Anesthesia Sets)

· Manufacturing Dates: January 2016 to November 2018

· Distribution Dates: April 2016 to December 2018

· Devices Recalled in the U.S.: 1,200

Reason for Recall

Draegar Medical is recalling its disposable VentStar and ID Breathing Circuits and Anesthesia Sets due to a risk of the devices being incorrectly assembled, resulting in a short-circuit in the breathing hose. If the breathing hose is short circuited, the patient will not receive the expected breathing support (ventilation). Lack of breathing support may result in irreversible patient harm, up to and including severe oxygen-loss (hypoxia) and death.

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