Events

Recall of Device Recall TransportAir

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
    25201
  • Event Risk Class
    Class 2
  • Event Number
    Z-0718-03
  • Event Initiated Date
    1997-06-01
  • Event Date Posted
    2003-04-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25372
  • 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, Air Fluidized - Product Code INX
  • Reason
    Battery out-gassing due to battery over charging and/or secondary failure mode of deep-discharge.
  • Action
    In approximately November 1997 the firm implemented the TransportAir retrograde for all active units.

Device

Device Recall TransportAir
  • Model / Serial
    Serial numbers 0550037 through 0559399.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    TransportAir, Accessory to an Air Bed, Auxiliary Blower Unit, manufactured by Kinetic Concepts, Inc.
  • Manufacturer
    Kinetic Concepts, Inc

Manufacturer

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