Reported Oct 3, 2012 · Terminated

BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or…

KCI USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: KCI USA, Inc. · 4958 Stout Dr · San Antonio, TX · 78219-4334

Is this the product you have?

  • 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
Lot codes and dates
  • Multiple
  • Serial Numbers with Model Numbers
    • 404000
    • 405500
    • 405500RF
Amount recalled
575

Where it was sold

  • Nationwide

Why it was 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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new packaged foods recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 29, 2013 · Data as of Sep 19, 6:13 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.