BEUDAMED
    FDA Recall Terminated

    Non-continuous ventilator accessories under the following brand names: a) RP-ComfortGel Gel Cushion M model number 1009050; b) RP-ComfortGel Gel Cushion P model number 1009048; c) RP-ComfortGel Gel Cushion S model number 1009049; d) RP-ComfortGel Silicone Flap L model number 1009109; e) RP-ComfortGel Silicone Flap M model number 1009054; and f) RP-ComfortGel Silicone Flap S model number 1009053. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    Recall: Z-1079-2008 · Initiated October 15, 2007

    Recall

    Recall Number
    Z-1079-2008
    Event Number
    45545
    Firm
    Respironics, Inc.
    FEI Number
    2518422
    Product Code
    BZD
    Status
    Terminated
    Root Cause
    Environmental control
    Initiated
    October 15, 2007
    Posted
    April 24, 2008
    Terminated
    September 1, 2009
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8550

    Description

    Non-continuous ventilator accessories under the following brand names: a) RP-ComfortGel Gel Cushion M model number 1009050; b) RP-ComfortGel Gel Cushion P model number 1009048; c) RP-ComfortGel Gel Cushion S model number 1009049; d) RP-ComfortGel Silicone Flap L model number 1009109; e) RP-ComfortGel Silicone Flap M model number 1009054; and f) RP-ComfortGel Silicone Flap S model number 1009053. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    Reason

    Foreign material: Glass fragments may present in the plastic bag material used to ship components.

    Action

    The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.

    Distribution

    The products were shipped nationwide to medical facilities.

    Quantity

    20950 units