Fisher & Paykel Healthcare has become aware that a connector component used in a previous version of its Continuous Positive Airway Pressure (CPAP) masks may fail prematurely if improperly cleaned. Plastic tabs incorporated into the connector components of these previous version CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the unlikely event of a tab breaking off, it may enter the CPAP system air path. CPAP masks are used in the treatment of Obstructive Sleep Apnea.
All masks manufactured since April 2006 have a new connector that does not feature tabs. These masks are not subject to the recall. The company estimates that only a small quantity of the previous version masks and connectors remain in the supply chain.
The company is consulting with the various international regulatory authorities to initiate appropriate action in each country. At this time, Fisher & Paykel Healthcare believes that this limited recall will not materially affect the company’s previously released earnings guidance.
About Fisher & Paykel Healthcare
Fisher & Paykel Healthcare is a leading designer, manufacturer and marketer of heated humidification products and systems for use in respiratory care and the treatment of obstructive sleep apnea. It also offers an innovative range of neonatal care products. The company’s products are sold in over 110 countries worldwide. For more information about the company visit www.fphcare.com
Contact: Michael Daniell MD/CEO on +64 9 574 0161 or Tony Barclay CFO on +64 9 574 0119.
Fisher & Paykel Healthcare Initiates Limited CPAP Mask and Connector Recall
Find clinical evidence and practice guidelines for delivering nasal high flow (aka HFNC) therapy.
Providing Optimal Humidity for intubated patients
Featuring under nose NIV masks (F&P Visairo) and full face NIV masks - (F&P Nivairo), with vented and non-vented options to suit your hospital NIV mask needs.
Establish effective spontaneous breathing or assist ventilation of the lungs
Respiratory support that replaces spontaneous breathing
Noninvasive respiratory support that provides a continuous distending pressure
Noninvasive respiratory support that delivers high flows of blended air and oxygen
Designed to work in harmony with the way patients naturally breathe while they sleep
F&P SleepStyle - designed to strike the balance between comfort and effective treatment