Z-1632-2014 Class II Terminated
FDA device recall Z-1632-2014 was initiated by SCM True Air Technologies LLC on March 18, 2014 and is designated Class II. Reason for recall: The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors. The recall status is terminated (terminated June 11, 2018). Affected quantity: 83 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 28, 2014
- Initiation Date
- March 18, 2014
- Termination Date
- June 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83 units
Product Description
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
Reason for Recall
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
Distribution Pattern
Nationwide Distribution including GA, KY, and MI.
Code Information
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.