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U.S. Department of Health and Human Services

Class 2 Device Recall BariAir Therapy System

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 Class 2 Recall
BariAir Therapy System
see related information
Date Posted September 27, 2012
Recall Status1 Terminated on July 29, 2013
Recall Number Z-2466-2012
Recall Event ID 62979
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
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.
Code Information Multiple Serial Numbers with Model Numbers: 404000,405500, 405500RF
Recalling Firm/
Manufacturer
KCI USA, Inc.
4958 Stout Dr
San Antonio, Texas 78219-4334
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact KCI's Customer Technical Service Center
800-275-4524
Manufacturer 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
FDA Determined
Cause 2
DESIGN: Device Design
Action 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.
Quantity in Commerce 575
Distribution Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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