Enforcement Report - Week of October 3, 2012
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Product Detail
| Product Description | 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. |
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| Recall Number | Z-2466-2012 |
| Classification | Class II |
| Code Info | Multiple Serial Numbers with Model Numbers: 404000,405500, 405500RF |
| Product Distributed Qty | 575 |
| 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 allowed the patient to unintentionally exit the therapy system, resulting in some patients receiving minor injuries. |
Event Detail
| Event Id | 62979 |
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| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | KCI USA, Inc. |
| City | San Antonio |
| State | TX | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-17 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria. |
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