BEUDAMED
    FDA Enforcement Class II Terminated

    MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.

    Recall: Z-1632-2014 · Reported May 28, 2014

    Enforcement

    Recall Number
    Z-1632-2014
    Event ID
    67924
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SCM True Air Technologies LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 28, 2014
    Initiation Date
    March 18, 2014
    Classification Date
    May 18, 2014
    Termination Date
    June 11, 2018
    Address
    7955 National Tpke Unit 100, N/A, Louisville, KY, 40214-4903, United States

    Description

    MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.

    Reason

    The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.

    Code Info

    Serial #'s 2054, 2055, 2056, 2057, 2058, 2059, 2060, 2061, 2062, 2063, 2067, 2068, 2069, 2070, 2071, 2072, 2073, 2074, 2075, 2076, 2077, 2078, 2079, 2080, 2081, 2082, 2083, 2084, 2085, 2086, 2087, 2088, 2089, 2090, 2091, 2092, 2093, 2094, 2095, 2096, 2097, 2100, 2101, 2102, 2103, 2106, 2107, 2108, 2109, 2110, 2111, 2112, 2113, 2114, 2115, 2116, 2126, 2127, 2128, 2129, 2135, 2136, 2137, 2138, 2139, 2118, 2119, 2120, 2122, 2123, 2124, 2125, 2141, 2142, 2143, 2144, 2145, 2146, 2147, 2148, 2149 & 2150.

    Distribution

    Nationwide Distribution including GA, KY, and MI.

    Quantity

    83 units