FDA Device recall Z-2466-2012
BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage pat…
- FDA Device
- Class II
- terminated
- Published 2012-10-03
On 2012-10-03 the FDA classified a Class II recall of BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage pat… by Kci Usa, citing 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 p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2466-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-17 |
| Published | 2012-10-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Kci Usa |
| Distribution | US |
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
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
Identifiers
| code_info | Multiple Serial Numbers with Model Numbers: 404000,405500, 405500RF |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2466-2012%22
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