Medical Device Recall: Z-0036-2007

FDA Recalls dataset · Firm: Medline Industries Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2006-07-20 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0036-2007.

Recall Res Number
Z-0036-2007
Recalling Firm / Manufacturer
Medline Industries Inc
FEI Number
1417592
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2006-07-20
Date Posted
2006-10-17
Date Terminated
2009-09-02
Product Code
INI
Event Number
36072
Product Quantity
93 scooters
Product Description Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807600 - red and MDS807600B - blue
Reason for Recall Under conditions of heavy use, signs of overheating of the main battery cables have been observed.
Action Details 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.
Distribution Pattern Nationwide
Code Information / Serial Numbers model MDS807600 - red and model MDS807600B - blue, all serial numbers

Related Establishments / Registrations

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