Reported May 28, 2014 · Terminated
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
SCM True Air Technologies LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SCM True Air Technologies LLC · 7955 National Tpke Unit 100 · Louisville, KY · 40214-4903
Is this the product you have?
- MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
- Lot codes and dates
81 of 81 codes
Serial #'s 205420552056205720582059206020612062206320672068206920702071207220732074207520762077207820792080208120822083208420852086208720882089209020912092209320942095209620972100210121022103210621072108210921102111211221132114211521162126212721282129
- Amount recalled
- 83 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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