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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Strider Maxi 4 Scooter

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  Class 2 Device Recall Medline Strider Maxi 4 Scooter see related information
Date Initiated by Firm July 20, 2006
Date Posted October 17, 2006
Recall Status1 Terminated 3 on September 02, 2009
Recall Number Z-0037-2007
Recall Event ID 36072
510(K)Number K041055  
Product Classification scooter - Product Code INI
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
Code Information model MDS807650 - red and model MDS807650B - blue, all serial numbers
Recalling Firm/
Manufacturer		 Medline Industries Inc
1 Medline Pl
Mundelein IL 60060-4486
For Additional Information Contact
800-289-9793
Manufacturer Reason
for Recall		 Under conditions of heavy use, signs of overheating of the main battery cables have been observed.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 223 scooters
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = INI and Original Applicant = MEDLINE INDUSTRIES, INC.
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