May 23, 2014 — Fisher & Paykel Healthcare has issued a recall for Infant Nasal CPAP Prongs because they can break and cut off oxygen to an infant. This problem could cause life-threatening health consequences, including choking and airway obstruction.
The company received 24 reports in which the prongs detached from nasal tubing during use. The problem is especially likely to occur when mucous and/or moisture are present. The recall does not include nasal tubing.
There are zero reports of injury or death, but the U.S. Food and Drug Administration (FDA) has issued a Class I recall because the problem could cause severe injury or death:
“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 are designed to connect with the Fisher & Paykel FlexiTrunk Patient Interface. The prongs are placed in the infant’s nostrils to provide continuous positive airway pressure (CPAP) by passing air through the infant’s nose. They are intended to be used in infants weighing up to 22 pounds in a hospital or clinical setting.
- 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 affected products were sold from June 6, 2013 and March 25, 2014. The manufacturer recommends that consumers identify any affected prongs in your inventory, destroy the prongs by cutting them in half, return a response form issued with the recall notification, and contact Fisher & Paykel for replacement parts.
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