BariAir Therapy System The BariAir Therapy System is a recall
BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The…
Why was BariAir Therapy System The BariAir Therapy System is a recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Multiple Serial Numbers with Model Numbers: 404000,405500, 405500RF
- Product
- BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The…
- Recalling firm
- KCI USA, Inc.
- Quantity
- 575
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.
- Recall date
- October 3, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)