- Draeger Medical is recalling its VentStar and ID Breathing Circuits and Anesthesia Sets due to the risk of a short circuit if the devices are not correctly assembled. Irreversible harm including severe oxygen loss and death could result if the breathing hose short circuits and patients do not receive ventilation, FDA said Friday.
- Healthcare professionals can tell if a breathing circuit has been incorrectly pre-assembled because, rather than a single cohesive hose system, there will be two separate subsystems.
- The Class I recall includes 1,200 devices that were manufactured between January 2016 and November 2018 and distributed between April 2016 and December 2018.
The recalled device is a single-use, disposable accessory that works with a ventilator or anesthesia machine to provide mechanical ventilation and breathing support for adults, children and infants under the supervision of a healthcare professional.
The company recalled the devices on Dec. 21 and sent an Urgent Medical Device Recall Notification to customers on that date with a series of instructions which includes checking the device before use to ensure that the connections of the breathing circuit are assembled correctly.
If a short-circuited breathing circuit is not detected during a pre-use inspection, it will not be possible to ventilate the patient, FDA warned.
Healthcare professionals should check whether the inspiratory and expiratory connectors of the ventilator or anesthesia machine are each connected to the Y-piece before use and after any temporary disconnection, FDA said.
Customers are instructed to inspect existing stock by following the provided inspection instructions and to complete and return the "Customer Reply and Order Form" to confirm that inspections have been completed. Free replacements can be ordered to replace breathing circuits that were pre-assembled incorrectly.
The model/item numbers of the recalled devices are:
- VentStar Circuits and Anesthesia Sets MP00349, MP00350, MP00351, MP00352, MP00361 and MP00374.
- ID Circuits and Anesthesia Sets MP01341, MP01348 and MP01350.