Events

Recall of Device Recall Flexicair II

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hill-Rom Manufacturing, 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
    57592
  • Event Risk Class
    Class 2
  • Event Number
    Z-1253-2011
  • Event Initiated Date
    2010-12-06
  • Event Date Posted
    2011-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96736
  • 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, flotation therapy, powered - Product Code IOQ
  • Reason
    Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used.
  • Action
    Hill-Rom Manufacturing, Inc. sent an Urgent Medical Device Withdrawal letter dated December 15, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. The FLEXICAR MC3 AND FLEXICAIR 13000 were no longer available for rental as of November 15, 2010. Customers in Michigan were required to switch to another product by December 31, 2010. All other customers were required to switch to another product by March 4, 2011. Customers advised to continue the use of the product until arrangements could be made to replace the product. were notified by letter on/about 12/06/2010. The letter indicated the units will no longer be available for rental as of 11/15/2010. Patients in Michigan currently using the products will be required to switch to another product by 12/31/2010. All other patients using the products will be required to switch to another product by 03/04/2010. They were advised that a Hill-Rom representative will be contacted them to discuss details of the product withdrawal and possible alternative surfaces for their patients. For questions regarding this recall call 800-445-3720.

Device

Device Recall Flexicair II
  • Model / Serial
    All Serial numbers. The devices have a nomenclature for each respective product model where the serial number is IBxxxxxx, where xxxxxx is a six digit number. The prefix IB is representative of a Flexicair II, prefix IC is representative of a Flexicair MC3 and a six digit number without a prefix is representative of a refurbished Flexicair MC 3.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including CA, FL, GA, IL, MI , MS, NJ, NY, OH and PA
  • Product Description
    Flexicair¿ II (Model number 13000) Low Airloss Therapy Units || For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure.
  • Manufacturer
    Hill-Rom Manufacturing, Inc.

Manufacturer

Hill-Rom Manufacturing, Inc.
  • Manufacturer Address
    Hill-Rom Manufacturing, Inc., 4349 Corporate Rd, Charleston SC 29405-7445
  • Source
    USFDA