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Published: 2014-05-28Captured: 2026-02-09SCM True Air Technologies LLCProduct: ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
FDA issued a Class II enforcement action. Affects SCM True Air Technologies LLC. Reason: The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approv.
- •Classification: Class II
- •Firm: SCM True Air Technologies LLC
- •Status: Terminated
- •Distribution: Nationwide Distribution including GA, KY, and MI.
Reason
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
Status:Terminated
Distribution:Nationwide Distribution including GA, KY, and MI.
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