BEUDAMED
    FDA Enforcement Class I Terminated

    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.

    Recall: Z-2741-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2741-2018
    Event ID
    80545
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Compass Health Brands (Corporate Office)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2018
    Initiation Date
    June 18, 2018
    Classification Date
    August 20, 2018
    Termination Date
    May 5, 2020
    Address
    6753 Engle Rd, Middleburg Heights, OH, 44130-7934, United States

    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

    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.

    Code Info

    All units manufactured after May 1, 2015

    Distribution

    US nationwide distribution to AL, CT, FL, GA, KY, MS, NC, NY, TN, and TX.

    Quantity

    742