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SCM True Air Technologies LLC recalls MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
Recalled May 28, 2014 · FDA recall Z-1632-2014 · SCM True Air Technologies
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. · FDA Class II
Units
83 units
Sold at
Nationwide Distribution including GA, KY, and MI.
Description
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
Product
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
Manufacturer(s)
SCM True Air Technologies LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →