FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Draeger Recalls Breathing Circuits and Anesthesia Sets

Feb. 1, 2019
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The FDA designated a recall by Draeger Medical of its VentStar ID breathing circuits and anesthesia sets as Class 1, noting the risk of serious injury or death if the breathing hose fails.

The devices are single-use, disposable, accessories used with a ventilator or anesthesia machine to provide breathing support to infant, child and adult patients. Draeger recalled 1,200 devices manufactured from January 2016 to November 2018.

The company noted the risk of the devices being incorrectly assembled, resulting in a short circuit in the breathing hose. An incorrectly pre-assembled breathing circuit will not be a single hose system but two separate sub-systems.

The FDA labeled the recall as Class I because of the risk of serious injury or death if the breathing hose fails.

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