CLASS II Device recall · Reported 3 Oct 2012 · FDA Enforcement Report
BariAir Therapy System The BariAir Therapy System is a risk recalled
KCI USA is recalling BariAir Therapy System The BariAir Therapy System is a risk management treatment system, distributed nationwide in the US. The recall was initiated on 17 Sep 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2466-2012
- FDA event ID
- 62979
- Recalling firm
- KCI USA, San Antonio, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Sep 2012
- FDA classified
- 27 Sep 2012
- Reported
- 3 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Sep 2012 | Recall initiated by company | |
| 27 Sep 2012 | Classified by FDA | +10 days |
| 3 Oct 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.
Questions about this recall
Why was it 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
Which lots are affected?
Multiple Serial Numbers with Model Numbers: 404000,405500, 405500RF
Where was it sold?
Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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