Z-2741-2018 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 29, 2018
- Initiation Date
- June 18, 2018
- Termination Date
- May 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 742
Product Description
CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The replacement cushion is a non-durable component that requires replacement every 3 - 6 months. The cushion is used for both comfort and to provide a seal between the face and the mask.
Reason for Recall
A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement part resulted in incompatibility of the new cushion seal with the previous design of the elbow. Use of the new cushion seal with the previous design elbow could lead to unacceptable CO2 porting. As there was no model number change for this design change, customers may not be aware of the incompatibility.
Distribution Pattern
US nationwide distribution to AL, CT, FL, GA, KY, MS, NC, NY, TN, and TX.
Code Information
All units manufactured after May 1, 2015