The US Food and Drug Administration (FDA) has identified Draeger Medical’s recall of the Seattle PAP Plus, VentStar, and other breathing circuit/anesthesia kits as a Class I recall.
According to the regulator, this is the most critical form of recall, and the use of devices under this category could result in serious injuries or death.
Draeger Medical is recalling the devices after identifying that glued connections could loosen before or during ventilation because of a manufacturing fault.
Partial or full detachment of parts including the water trap, hose connector, or y-piece, may happen as a result, said the FDA.
The loosening or detachment of these components can potentially disrupt the breathing circuit, thereby posing a significant risk of severe harm such as oxygen deprivation (hypoxia) or fatality. Critically ill patients, including newborns (neonates), are particularly vulnerable to the heightened danger of injury or death, said the FDA.
Draeger Medical has reported no instances of injuries or fatalities associated with this matter.
The intended use of the Draeger Medical Seattle-Positive Airway Pressure (PAP) Plus system is to deliver Bubble continuous positive airway pressure (CPAP) therapy. It is designed specifically to assist hospitalised infants experiencing respiratory distress in their breathing efforts.
The other products in the recall are breathing circuits and anesthesia kits. These items are utilised alongside ventilators during surgical procedures or in intensive care units for supporting the respiratory functions of infants, children, and adults.
Initiated by the medical equipment maker on 17 April 2023, the recall involves a total of 570,459 devices in the US. The impacted devices were distributed between 1 January 2019 and 28 February 2023.
Some of the products that are part of the recall are Seattle PAP Plus, VentStar Basic (P)180, Anesthesia Circuit Kit Coax 1, Anesthesia Circuit Kit Coax 3, and Anesthesia Circuit Kit Coax HEPA among others.
