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Infant Nasal Tube Prongs Recalled by Fisher & Paykel

Infant Nasal Tube Prongs Recalled by Fisher & Paykel

May 23, 2014 — The U.S. Food and Drug Administration (FDA) is warning that Infant Nasal CPAP Prongs can potentially detach from nasal tubing and cut off the oxygen-supply to an infant, which could potentially cause life-threatening health consequences.

The manufacturer, Fisher & Paykel Healthcare, has received 24 reports in which the prongs detached, especially when mucous and/or moisture are present. There are no reports of injury or death. However, the FDA has issued a Class I recall because the problem could be deadly:

“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 Fisher & Paykal Nasal CPAP Prongs provide continuous positive airway pressure (CPAP) by forcing air through the patient’s nose. It is designed to be used with the FlexiTrunk Patient Interface. Nasal tubes are not part of the recall. The affected products were distributed from June 6, 2013 through March 25, 2014.

What Should I Do?

Recommendation for healthcare professionals:

  • 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.

Fisher & Paykel recommends that healthcare professionals should look through their inventory and identify any products that have been recalled by checking a list of recalled model and lot numbers. These products should be quarantined and destroyed by cutting them in half. Fisher & Paykel should be contacted for replacement parts.

Do I have an Infant Nasal Tube Recall Lawsuit?

The Schmidt Firm, PLLC is currently accepting defective medical device induced injury cases in all 50 states. If you or somebody you know has been injured by recalled Infant Nasal CPAP Prongs, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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