MaXair True Low Air Loss Mattress Replacement System recall
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
Why was MaXair True Low Air Loss Mattress Replacement System recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
- Recalling firm
- SCM True Air Technologies LLC
- Quantity
- 83 units
- Distribution
- Nationwide Distribution including GA, KY, and MI.
- Recall date
- May 28, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)