Reported Oct 3, 2012 · Terminated
BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or…
KCI USA, Inc.
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: KCI USA, Inc. · 4958 Stout Dr · San Antonio, TX · 78219-4334
Is this the product you have?
- BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient positioning capabilities and built-in scales for patients weighing 300 Ib* to 850 Ib ([136*-386 kg] including accessories). The BariAir
- Therapy System is indicated to aid in" Patients whose body weight and size pose a significant risk or care management issue to the patient or staff during the performance of routine nursing care. " Large patients weighing between 300 Ib* and 850 Ib (136*-386 kg) including accessories. " Large patients who are difficult to turn. " Preventing and treating pressure ulcers. " Large patients requiring percussion therapy
- Lot codes and dates
- Multiple
- Serial Numbers with Model Numbers
404000405500405500RF
- Amount recalled
- 575
Where it was sold
- Nationwide
Why it was recalled
KCI has issued a medical device correction for the BariAir Therapy System Hand Pendent. The BariAir Therapy System is not designed to allow the patient to place the bed into the patient exit position. KCI has received complaints indicating that patients used the hand pendent to inadvertently place the BariAir Therapy System into a pseudo-exit position. In a small number of instances, this allow
This product could cause temporary or reversible health problems — stop using it.
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