FDA regulators put their highest-level warning on Fisher & Paykel’s recall of infant CPAP components, warning that the defect may pose a choking risk to babies.
F&P initiated the recall last month after receiving 24 reports that infant nasal CPAP prongs had malfunctioned. The prongs had detached from tubing, interrupting therapy and potentially causing low blood oxygen. The prongs may also fall into babies’ mouths, where they may block airways, according to the FDA memo.
There have been no injuries or deaths associated with the defect thus far, the agency noted.
The recall affects F&P’s infant nasal CPAP prongs and Bubble CPAP starter kits manufactured from June 6, 2013, through March 25, 2014, according to the memo. The tubing itself is not affected by the recall.
The prongs are placed in an infant’s nostrils to deliver continuous positive airway pressure, or CPAP, therapy. The F&P prongs are indicated specifically for patients up to 22 pounds, for use in hospital or clinical settings where babies are closely monitored.
F&P asked its customers to ensure that the affected prongs are destroyed by cutting them in half and disposing of all units. The company plans to issue a credit or provide customers with an older model of the prongs.