Fisher and Paykel Healthcare, Ltd., Infant Nasal CPAP Prongs: Class I Recall - Prongs May Detach from Nasal Tubing and Interrupt Therapy

[Posted 05/23/2014]

AUDIENCE: Risk Manager, Nursing, Pediatrics, Biomedical Engineer

ISSUE: Fisher & Paykel Healthcare received 24 reports in which 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 use of the affected product may cause serious adverse health consequences, including death.

See the recall notice for a list of affected model and lot numbers.

BACKGROUND: 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 (CPAP) 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.

RECOMMENDATION: Starting April 11, 2014, Fisher & Paykel Healthcare sent its customers an Urgent Medical Device Recall letter. The letter identified the product, problem, and actions to be taken, which include:

• Identify any Affected Prongs in your inventory by checking the REF and LOT number on the packaging. For Starter Kits, only the Nasal CPAP Prongs are affected and the rest of the Starter Kit is suitable for use.
• Destroy the Affected Prongs by cutting them in half and disposing of the products.
• Complete Section A ‘Inspection of Stock’ on the Urgent Medical Device Recall Response Form and return it to your FPH Representative.
• Contact your FPH Representative for replacement products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[05/23/2014 - Recall Notice - FDA]