Infant Nasal CPAP Prong Recall Issued Due to Risk of Tubing Detaching

The FDA is warning that problems with infant nasal CPAP prongs from one manufacturer could pose a risk of severe injury or death for some infants.  

Last week, the FDA gave a class 1 medical device recall designation to an Infant Nasal CPACP Prong recall issued in April. The prongs were manufactured by Fisher and Paykel and connect to the Fisher and Paykel Healthcare FlexiTrunk Patient Interface. On April 15, the company recalled them following 24 reports of malfunctions.

The prongs are used to deliver continuous positive airway pressure (CPAP) to infants having trouble breathing, but are not meant to be used as a life supporting device.

Reports indicate that the prongs can detach during use, especially when there is mucus or moisture. This is likely to interrupt therapy and may cause low blood oxygen. The prongs could also enter the infant’s mouth when loose, causing a choking and death risk. Although at least two dozen reports of problems have been received, no injuries or deaths have been confirmed to date.

The recall affects Infant Nasal CPAP Prongs (10 pack) and Bubble CPAP Starter Kits. The recalled prongs were manufactured and distributed between June 6, 2013 and March 25, 2014. A complete list of model numbers and lot numbers of affected prongs is available in the FDA announcement linked above.

The class 1 medical device recall designation means that the FDA has determined that the problem with the prongs has a high probability of causing severe injury or death. It is the most serious medical device recall classification.

The manufacturer has indicated that it will work with customers to identify alternative products or therapies and warns that replacing some stock for some customers may take several months.

The company recommends that its customers identify affected prongs by checking the lot or REF numbers, use patient oxygen monitoring, and to “check that all circuit connections are tight before use and after any adjustment.”

Customers with questions can call (800) 792-3912, extension 1423 or email Raymond.Yan@fphcare.com.