Events

Recall of Device Recall Medline Strider Maxi 4 Scooter

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
    36072
  • Event Risk Class
    Class 2
  • Event Number
    Z-0037-2007
  • Event Initiated Date
    2006-07-20
  • Event Date Posted
    2006-10-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48121
  • 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
    scooter - Product Code INI
  • Reason
    Under conditions of heavy use, signs of overheating of the main battery cables have been observed.
  • Action
    Medline sent 'Voluntary Field Correction' letters dated 7/20/06 to the direct accounts on the same date, informing them that the Strider Maxi 3 and Maxi 4 scooters have main battery cables that may overheat under conditions of heavy use, and that Medline will provide an upgrade kit to replace the battery cables. Any questions were directed to 800-289-9793, press 1, then press 3 and ask to transfer to 4674 (8:00 AM to 5:00 PM CST). Follow-up letters were sent to the distributors and end-users on 10/31/06. The end users were informed of the problem with the scooters, and were requested to call Medline at 800-289-9793, press 1, then press 3 and ask to transfer to 4674 (8:00 AM to 5:00 PM CST) to have the scooter upgraded. The end users were requested to inform the service technician that hey have one of the affected Maxi Scooters, and provide him with their full name, phone number and street address, as well as the name, address and/or phone number of teh store where the Medline Scooter was purchased. Medline will arrange with the dealership or retail store to upgrade the scooter at no cost to the end user.

Device

Device Recall Medline Strider Maxi 4 Scooter
  • Model / Serial
    model MDS807650 - red and model MDS807650B - blue, all serial numbers
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Medline Strider Maxi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807650 - red and MDS807650B - blue
  • Manufacturer
    Medline Industries Inc

Manufacturer

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