FDA-Device2014-05-28Class II
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
SCM True Air Technologies LLC
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.
Sold states
Nationwide Distribution including GA, KY, and MI.
Affected count
83 units
Manufactured in
7955 National Tpke Unit 100, N/A, Louisville, KY, United States
Products
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1632-2014Don't want to check this manually?
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