The FDA issued a Class I recall for Fisher & Paykel Healthcare’s Infant Nasal CPAP Prongs, due to the fact that the prongs may detach from nasal tubing and interrupt therapy, according to an FDA announcement.
Fisher & Paykel Healthcare received 24 reports in which the affected prongs detached from the nasal tubing during use, especially when mucous and/or moisture are present, the announcement states.
When the affected prongs detach from the nasal tubing, therapy is likely to be interrupted. This may cause low blood oxygen (hypoxemia). The detached prongs may enter an infant’s mouth and present a potential risk of choking and airway obstruction. The use of the affected product may cause serious adverse health consequences, including death.
See the recall notice for a list of affected model and lot numbers.
