Draeger Medical

This week, the FDA labeled Draeger’s recall of some ventilators as Class I, the most serious kind.

Draeger issued a voluntary correction, not a product removal, of specific Carina sub-acute care ventilators. The company said clinicians may continue to use the devices with adult patients and are instructed not to use the devices with pediatric patients.

Draeger is recalling the Carina ventilators due to contaminants in the device’s airpath. The contaminants exceed acceptable levels if used by pediatric patients for more than 30 days. Draeger found polyether polyurethane during testing in the airpath of the Carina ventilator. This results in the emission of contaminant 1,3-Dichloropropan-2-ol, a potential carcinogen.

Continued use of the Carina ventilators in pediatric patients could result in serious adverse health consequences, including exposure to hazardous chemicals, toxic reactions and death.

The recall affects 703 devices with dis…

The Oxylog 3000 ventilator. [Image from the Draeger Medical website]The FDA labeled a recall of the Draeger Medical Oxylog 3000 plus emergency and transport ventilator Class I, the most serious kind.

Draeger designed its Oxylog 3000 ventilator for people who require full or partial breathing assistance from a mechanical ventilator. Healthcare professionals use it during patient transport, either in an ambulance or aircraft. They also use it to move people using ventilators throughout the hospital and recovery room.

According to an FDA notice, Draeger recalled the ventilator after receiving reports that it stopped ventilation due to a depleted battery. This occurred even after reconnection to AC power. The ventilator may not automatically switch back to using AC power when plugged in. In this case, it may continue using the battery until depleted, before stopping ventilation.

The FDA said a battery alarm — “Charge int. battery” and “Int. ba…

SafeStar mechanical filters produced by Draeger. [Image from Draeger’s website]The FDA today issued a notice confirming that a recall of ventilator filters from Draeger is Class I, the most serious kind.

Draeger’s SafeStar 55 breathing system filter (model number MP01790), distributed between Aug. 18, 2021, and Oct. 12, 2021, is the affected product.

The company initiated the recall on May 9, 2022, and has recalled 35,950 total devices in the U.S. to date. According to the FDA notice, there has been one complaint and one injury associated with use of the device with no reported deaths.

Draeger’s SafeStar 55 comprises part of a ventilator for use when a patient is under anesthesia or needs breathing assistance. It is designed to reduce contaminants such as bacteria, other micro-organisms and small particles that reach a patient who is receiving breathing support from the ventilator.

The company recalled the specific LT2103 lot of the…