BariAir Therapy System The BariAir Therapy System is a risk… — Class II medical device recall Z-2466-2012
Terminated recall by KCI USA, Inc., reported 2012-10-03, distributed nationwide. KCI has issued a medical device correction for the BariAir Therapy System Hand Pendent. The BariAir Therapy Sy
| Recall number | Z-2466-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | KCI USA, Inc., San Antonio, TX, United States |
| Recall initiated | 2012-09-17 |
| Classified | 2012-09-27 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2013-07-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, DE, GB, KW, SA, SG |
| Quantity | 575 |
| Model numbers | 404000, 405500, 405500RF |
Product
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.
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.