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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Excel Shuttle Wheelchair, 28" Wide

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  Class 2 Device Recall Medline Excel Shuttle Wheelchair, 28" Wide see related information
Date Initiated by Firm March 31, 2008
Date Posted August 19, 2008
Recall Status1 Terminated 3 on May 11, 2010
Recall Number Z-1772-2008
Recall Event ID 47781
510(K)Number K051302  
Product Classification Mechanical Wheelchair - Product Code IOR
Product 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.
Code Information Item numbers MDS809800 and MDS809850, all wheelchairs purchased between 12/01/2005 and 08/31/2007
Recalling Firm/
Manufacturer		 Medline Industries Inc
1 Medline Pl
Mundelein IL 60060-4486
For Additional Information Contact Ms. Kathy Dunne
866-359-1704
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Component design/selection
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.
Quantity in Commerce 201 wheelchairs
Distribution Class II Recall - Worldwide Distribution --- including USA and Canada.
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 = IOR and Original Applicant = MEDLINE INDUSTRIES, INC.
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