—#48121

Product

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

FDA product code: INI — Vehicle, Motorized 3-Wheeled
Device class: Class 2
Medical specialty: Physical Medicine
510(k) numbers: K041055
Affected lot / code info: model MDS807650 - red and model MDS807650B - blue, all serial numbers

Why it was recalled

Under conditions of heavy use, signs of overheating of the main battery cables have been observed.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: 1 Medline Pl, Mundelein, Illinois 60060-4486

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2006-07-20
Posted by FDA: 2006-10-17
Terminated: 2009-09-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48121. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.