Z-2466-2012Class II

BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large...

Name: Z-2466-2012 BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large...
Creator: KCI USA, Inc.
Published: 2012-09-17
License: https://open.fda.gov/license/

KCI USA, Inc. / initiated 2012-09-17 / Terminated / root cause: design

FDA source

KCI USA, Inc. began a recall of BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir... on 2012-09-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2466-2012
Classification: Class II
Status: Terminated
Initiated: 2012-09-17
Posted: 2012-09-27
Terminated: 2013-07-29
Recalling firm: KCI USA, Inc.
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.
Product code: FNL Bed, Ac-Powered Adjustable Hospital
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
Root cause tag: design
FDA root cause: 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.
Product codes and lots: Multiple Serial Numbers with Model Numbers: 404000,405500, 405500RF

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2466-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2466-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-27

Product code FNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)