Events

Recall of Device Recall Medline Excel Shuttle Wheelchair, 28" Wide

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medline Industries 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
    47781
  • Event Risk Class
    Class 2
  • Event Number
    Z-1772-2008
  • Event Initiated Date
    2008-03-31
  • Event Date Posted
    2008-08-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70165
  • 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
    Mechanical Wheelchair - Product Code IOR
  • Reason
    Injuries to fingers. there is a potential for users to pinch their fingers between the seat bars when opening the wheelchairs. the injuries can be severe from fracture to severing.
  • Action
    A Voluntary Field Correction letter dated 3/31/08 was issued to customers. The letter informed them of reports of users catching their fingers under the seat bars, which are identified on the chair with warning stickers. The customers were requested to change the backrest with the enclosed replacement upholstery kit, properly dispose of the old back rest, and place the enclosed cautionary tags on both sides of the chair seat. Instructions for installation of the upholstery and cautionary tags were included, as was a sheet entitled "How to Open a Wheelchair" which gives step by step instructions with illustrations for opening the wheelchair, as well as the warning "CAUTION KEEP YOUR FINGERS ON TOP OF THE UPHOLSTERY AT ALL TIMES. DO NOT PLACE YOUR FINGERS ON THE SIDES OR BOTTOM OF THE CHAIR SEAT." The accounts were requested to complete the enclosed response sheet and fax it back to Medline at 847-643-4482, indicating the serial numbers of chairs corrected. Any questions were directed to 800-633-5463, extension 5349, between 8:00 AM and 5:00 PM CST. Distributors were requested to notify their accounts of the recall.

Device

Device Recall Medline Excel Shuttle Wheelchair, 28" Wide
  • Model / Serial
    Item numbers MDS809800 and MDS809850, all wheelchairs purchased between 12/01/2005 and 08/31/2007
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Class II Recall - Worldwide Distribution --- including USA and Canada.
  • Product Description
    Bariatric Wheelchair, 28" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries, Inc., Mundelein, IL 60060 USA; || Item #MDS809800 comes with Removable Desk-Length Arms, Swing-Away Detachable Footrests, Hemi-Height Adjustable. || item #MDS809850 comes with Removable Desk-Length Arms, Swing-Away Detachable Elevating Legrests, Hemi-Height Adjustable.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Manufacturer Address
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4486
  • Source
    USFDA