KCI Recalls BariAir Therapy System Hand Pendent Due to Positioning Risk

Plain-English summary

KCI USA, Inc. has issued a medical device correction for the BariAir Therapy System Hand Pendent. The recall involves 575 units distributed worldwide, including the United States, Saudi Arabia, the United Kingdom, Singapore, Germany, Switzerland, Kuwait, the United Arab Emirates, and Austria. The affected devices are identified by Model Numbers 404000, 405500, and 405500RF.

The recall was initiated because the BariAir Therapy System is not designed to allow the patient to place the bed into the patient exit position. KCI received complaints indicating that patients used the hand pendent to inadvertently place the system into a pseudo-exit position. In a small number of instances, this action allowed the bed to move in a way that was not intended by the device's design.

Healthcare facilities and consumers with these devices should stop using the hand pendent and contact KCI USA, Inc. for instructions on the correction. The BariAir Therapy System is a risk management treatment system designed for large and difficult-to-manage patients, providing low air-loss pressure management therapy, pulsation, percussion, and flexible patient positioning capabilities.

The recalled product

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

Manufacturer

KCI USA, Inc.

Category

Medical Device — Patient Positioning / Pressure Management

Hazard

• unintended-movement
• patient-fall-risk

Affected units

575

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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