BEUDAMED
    FDA Recall Terminated

    ComfortGel Nasal Mask size small

    Recall: Z-0178-04 · Initiated September 29, 2003

    Recall

    Recall Number
    Z-0178-04
    Event Number
    27436
    Firm
    Respironics, Inc.
    FEI Number
    2518422
    Product Code
    BZD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 29, 2003
    Posted
    December 10, 2003
    Terminated
    March 1, 2004
    Address
    1001 Murry Ridge Lane, Murrysville, PA, 15668

    Description

    ComfortGel Nasal Mask size small

    Reason

    product does not contain built in exhalation port

    Action

    The recalling firm telephoned the direct accounts to inform them of the problem and the need to return the product.

    Distribution

    The products were shipped to sleep centers nationwide and in Canada.

    Quantity

    5293 units