Sometimes even the most simple design changes can create a safety issue. That seems to be the takeaway from a Class I recall that one manufacturer of a continuous positive airway pressure (CPAP) mask is dealing with.
Compass Health is recalling the replacement cushion seals for the Probasics Brand Zzz-Mask SG Full Face CPAP Mask due to a design change made to the cushion seal replacement part and accompanying elbow replacement part that causes the seal to be incompatible with the mask. The company initiated the recall in May and sent an urgent notice to customers on June 19, and FDA announced on Friday that the recall has been placed in the Class I category, which is considered to be the most serious type of medical device recall.
FDA said no patient complaints or injuries have been reported, but the use of the new cushion with the previous design of the mask could result in an air leak that interrupts therapy. The use of the affected mask seal may cause serious adverse health consequences, including increased risk of bronchitis or pneumonia, apnea, high blood pressure, heart attack, or even death.
The replacement seals included in the recall were manufactured after May 1, 2015, and distributed between May 4, 2015, and October 10, 2017. The agency said the recall includes 742 products that were distributed nationwide.
The Probasics Brand Zzz-Mask SG Full Face CPAP Mask is designed for patients requiring CPAP for the treatment of obstructive sleep apnea in the home, hospital, or another clinical setting. CPAP machines use mild air pressure to keep airways open during sleep. The air is delivered through a mask that fits over the nose and mouth. The mask contains an elbow adapter which allows the user to connect the mask to the CPAP machine. The mask cushion is used for both comfort and to provide a seal between the face and the mask.
Any consumer using an incompatible cushion/elbow combination are being instructed to discontinue use of the mask and contact their dealer for a replacement kit. Dealers do not need to return the affected product to Compass Health, according to FDA's recall notice, but all affected products in stock should be disposed of.
See FDA's recall notice for further instructions regarding the product in question.