Home / Recalls / KCI USA, Inc. / Z-2466-2012

Z-2466-2012 Class II Terminated

Recalled by KCI USA, Inc. — San Antonio, TX

Recall Details

Product Type
Devices
Report Date
October 3, 2012
Initiation Date
September 17, 2012
Termination Date
July 29, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
575

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.

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

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.

Code Information

Multiple Serial Numbers with Model Numbers: 404000,405500, 405500RF

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