FDA designates Draeger Medical Seattle PAP Plus recall as class I

Key takeaways:

• The FDA designated the recall of Draeger Medical’s Seattle-Positive Airway Pressure Plus system as class I.
• For those with affected products, Draeger Medical recommends starting alternative therapies.

The FDA has designated Draeger Medical’s recall of the Seattle-Positive Airway Pressure Plus system as a class I recall, the most serious kind.

Further, VentStar and other breathing circuit/anesthesia kits from the company are also included in this recall, according to an FDA alert.

With the ability to provide Bubble continuous positive airway pressure (CPAP) support, the Seattle-Positive Airway Pressure Plus system helps infants in the hospital who are experiencing respiratory distress. Additionally, the breathing circuit/anesthesia kits help infants, children and adults breathe alongside a ventilator when they undergo surgery or are admitted to the ICU.

The devices were recalled because glued connections of the products could loosen prior to a patients’ ventilation or while they are receiving ventilation, and this can disturb the breathing circuit and potentially result in hypoxia or death, according to the FDA alert. Notably, patients who are critically ill face a higher risk for adverse outcomes.

The recall is for 570,459 devices in the United States, according to the alert. The affected units were distributed from Jan. 1, 2019, to Feb. 28, 2023.

There are currently no injuries or deaths, Draeger Medical reported to the FDA.

Draeger Medical sent users an Urgent Medical Device Recall letter in April 2023, saying that they should stop using any breathing circuits shipped before March 20, 2023, and quickly begin using an alternative therapy, such as nasal CPAP, noninvasive positive pressure ventilation or high flow nasal cannula. A last resort alternative is invasive mechanical ventilation, according to the FDA alert.