Draeger Medical Recalls Seattle PAP Plus and Breathing Circuit/Anesthesia Kits for Risk of Loose or Detached Components That Can Restrict Breathing Support

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.

The Draeger Medical Seattle-Positive Airway Pressure (PAP) Plus system is intended to provide Bubble continuous positive airway pressure (CPAP) therapy that supports infants who are struggling to breathe (in respiratory distress) while in the hospital.

The other products included in this recall are breathing circuit and/or anesthesia kits used together with ventilators during surgery or in the intensive care unit to support the breathing of infants, children, and adults.

Draeger Medical is recalling the Seattle PAP Plus as well as VentStar and other breathing circuit/anesthesia kits after finding that glued connections may loosen before or during ventilation due to a manufacturing error. Partial or complete detachment of components including the water trap, y-piece, or hose connector, may occur as a result.

Loosening or detachment of these parts can interrupt the breathing circuit and may cause severe injury including lack of oxygen (hypoxia) or death. The risk of injury or death is especially great for critically ill patients including newborns (neonates).

Draeger Medical reports no injuries or deaths related to this issue.

In April 2023, Draeger sent affected customers an Urgent Medical Device Recall letter with the following recommendations for breathing circuits shipped before March 20, 2023 that may be affected by this issue:

For questions about this recall, contact Michael Kelhart between the hours of 8:00 AM – 4:30PM EST at 267-664-1131 or via email at [email protected].

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using the online form or call 1-800-332-1088 for more information on how to mail or fax the form.

05/24/2023