Fisher and Paykel’s Infant Nasal Continuous Positive Airway Pressure (CPAP) Prongs (10 Pack) and Bubble CPAP Starter Kits are subject to a Class I recall. Fisher and Paykel Healthcare received 24 reports in which the device has malfunctioned. The affected prongs detached from the nasal tubing during use, especially when mucous and/or moisture are present. 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 Nasal CPAP Prongs connect to the Fisher and Paykel Healthcare FlexiTrunk Patient Interface. The prongs are placed in the patient’s nostrils to deliver continuous positive airway pressure, which involves passing air through an infant’s nose. The prongs are used in patients weighing up to 22 pounds in a hospital or clinical setting where the patient is monitored by trained medical staff. The device is not intended to be used as a life supporting device.
The affected products were manufactured and distributed from June 6, 2013, through March 25, 2014. The Nasal Tubing is not affected by this recall.
Users should to refer to the User Instructions and pay attention to the following warnings:
- Always use pressure monitoring to verify that the patient is receiving the prescribed CPAP level.
- Use patient oxygen monitoring.
- Check that all circuit connections are tight before use and after any adjustment.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall