The Seattle-PAP Plus system offers bubble CPAP therapy to infants who are in respiratory distress. Credit: Alexander Grey on Unsplash.

Draeger Medical has recalled Seattle-Positive Airway Pressure (PAP) Plus and breathing circuit/anaesthesia kits due to a manufacturing defect.

The company has recalled a total of 570,459 of these devices in the US and this was initiated due to the possibility of restricted breathing support caused by loose or detached components.

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The FDA has classified the action as a Class I recall, the most serious type of recall indicating the potential for serious injuries or death if the affected devices are used.

The company stated that a manufacturing error may result in the loosening of glued connections before or during ventilation. This may lead to the detachment of components such as the water trap, y-piece or the hose connector, either partially or completely.

The defect may potentially result in severe injury, including lack of oxygen (hypoxia) or death. Critically ill patients, including newborns, are particularly vulnerable to the risk of injury or death in such cases.

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The Seattle-PAP Plus system is designed to aid infants who are in respiratory distress by offering bubble continuous positive airway pressure therapy, which assists them in breathing while in the hospital.

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The breathing circuit and anaesthesia kits supplied by Draeger are utilised alongside ventilators for supporting the breathing needs of individuals, including infants, children and adults, during surgical procedures or in intensive care units.

Last month, the affected customers were alerted by the company through an urgent medical device recall letter, which provided crucial recommendations, including avoiding the use of affected products.