The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The following recall has been posted on FDA.gov.
- Recalled Product(s): Replacement Cushion Seals for Probasics Brand Zzz-Mask SG Full Face CPAP Mask
- Product Codes: PB781S, PB781M, PB781L, 781S, 781M and 781L
- Manufacturing Dates: May 1, 2015 to unknown
- Distribution Dates: May 4, 2015 to October 10, 2017
- Devices Recalled in the U.S.: 742 nationwide
The Probasics Brand Zzz-Mask SG Full Face CPAP Mask is designed for patients requiring Continuous Positive Airway Pressure (CPAP) for the treatment of obstructive sleep apnea in the home, hospital, or other 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.
Reason for Recall
Compass Health is recalling the replacement cushion seals for the Probasics Brand Zzz-Mask SG Full Face CPAP Mask due 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. While no complaints or injuries have been reported, 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 death.
Who is affected?
- Patients who use the Probasics Brand Zzz-Mask SG Full Face CPAP Mask.
- Health care providers who prescribe the Probasics Brand Zzz-Mask SG Full Face CPAP Mask.