Recall of BariAir

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kinetic Concepts, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25197
  • Event Risk Class
    Class 2
  • Event Number
    Z-0414-03
  • Event Initiated Date
    1998-10-21
  • Event Date Posted
    2003-01-09
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2003-01-28
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bed, Ac-Powered Adjustable Hospital - Product Code FNL
  • Reason
    Electrical failure of the bed due to fluid egress into the junction box.
  • Action
    In an October 21, 1998 e-mail the firm requested return of the product for a planned upgrade. The junction box cover was corrected at the same time of the upgrade.

Device

  • Model / Serial
    All serial numbers of beds produced and distributed to the firm''s service centers at the time of correction.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    KCI BariAir Therapy System; AC-Powered Adjustable Hospital Bed; Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Kinetic Concepts, Inc, 4958 Stout Drive, San Antonio TX 78219
  • Source
    USFDA