Recall Z-1632-2014— SCM True Air Technologies LLC

Name: FDA recall Z-1632-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-18

Class II · Terminated

Class II FDA medical device recall by SCM True Air Technologies LLC, initiated 2014-03-18, terminated 2018-06-11. FDA's recall record names no specific 510(k) clearance for this event. Product: MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.. 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..

Recalling firm: SCM True Air Technologies LLC
Classification: Class II
Status: Terminated
Initiated: 2014-03-18
Terminated: 2018-06-11
Firm location: Louisville, KY, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.