The FDA slapped the April 15 recall of Fisher & Paykel Healthcare's Infant Nasal CPAP Prongs and Bubble CPAP Starter Kits with its most severe label, meaning the now Class I recall involves "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
The prongs are placed in infants' nostrils to deliver continuous positive airway pressure through the nose and are an element in the starter kit, according to company's product catalog. They connect to the FlexiTrunk Patient Interface, which is the company's nasal tubing.
The company received 24 reports of device malfunction. The problems occurred when the prongs detached from the nasal tubing and interrupted therapy, FDA said. This can cause low blood oxygen and presents a choking risk to the infant. Fisher & Paykel said the problem did not result in any deaths or injuries.
The recall notice recommends that users monitor the device and check that connections are tight before use and following any adjustment.
Fisher & Paykel will help customers find alternative products or alternative therapies until they receive the previous version of the prongs. This could could take several months, the notice says. It also contains a list of the affected model and lot numbers.
Japan's Fisher & Paykel makes a variety of respiratory humidification systems and associated accessories. It also sells CPAP devices for the treatment of sleep apnea.
- read the FDA's recall notice