FDAFDA · Food and drugs·Recall number Z-1632-2014
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
Published May 28, 2014 · Recall initiated: March 18, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SCM True Air Technologies LLC
- Distributor
- Nationwide Distribution including GA, KY, and MI.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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