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.
This recall has been terminated (originally issued September 27, 2012).
- Company
- Kci Usa, Inc.
- Recall Initiated
- September 17, 2012
- Posted
- September 27, 2012
- Terminated
- July 29, 2013
- Recall Number
- Z-2466-2012
- Quantity
- 575
- Firm Location
- San Antonio, TX
- Official Source
- View on FDA website ↗
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
Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.
Lot / Code Info
Multiple Serial Numbers with Model Numbers: 404000,405500, 405500RF
Root Cause
Device Design
Action Taken
KCI sent an Urgent - Voluntary Medical Device Correction letter dated September 13, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers would be contacted by KCI to coordinate a shipment of a replacement product. For questions customers would instructed to call 1-800-275-4524, Select Option 3 followed by Option 2. For questions regarding this recall call 1-800-275-4524.