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U.S. Department of Health and Human Services

Class 2 Device Recall McKesson SunMark Performance Wheelchair, 20" Seat

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  Class 2 Device Recall McKesson SunMark Performance Wheelchair, 20" Seat see related information
Date Initiated by Firm May 03, 2004
Date Posted March 22, 2005
Recall Status1 Terminated 3 on August 19, 2005
Recall Number Z-0645-05
Recall Event ID 31147
510(K)Number K002670  
Product Classification Wheelchair, Mechanical - Product Code IOR
Product Manual Mechanical Wheelchair, 20'' seat, , maximum patient weight: 350 lbs.; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in China; the wheelchairs were sold in the following configurations:
reorder 16-7942: Removable Desk Arm, Swing Footrest
reorder 16-7943: Removable Desk Arm, Elevating Adjustable Legrest
reorder 16-7944: Removable Full Arm, Elevating Adjustable Legrest
Code Information reorder no. 16-7942, 16-7943, 16-7944, all serial numbers
Recalling Firm/
Manufacturer		 Cypress Medical Products, Ltd.
1202 S. Rte 31
McHenry IL 60050
For Additional Information Contact Ms. Kristine Ozyuk
815-385-0100
Manufacturer Reason
for Recall		 The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
FDA Determined
Cause 2		 Other
Action Cypress Medical telephoned McKesson on 5/3/04, informing them of the problem with the rivet screw collar and requesting them to place the wheelchairs on hold in their distribution warehouses, pending inspection and tightening of the rivet screws to properly seat the rivet crew collar into the frame. Cypress also called all direct accounts in June and July 2004, and known end users in January 2005. Voluntary Field Correction letters dated 3/3/05 are being sent to those end users who could not be reached by telephone.
Quantity in Commerce 6 chairs
Distribution Nationwide through McKesson Medical-Surgical warehouses in Kansas City, MO; Suwanee, GA; Baltimore, MD; Orlando, FL; Charlotte, NC; Nashville, TN; Richmond, VA; Atlanta, GA; Little Rock, AR; Grapevine, TX; Denver, CO; Tewksbury, MA; Cheshire, CT; Grove City, OH; Rochester, NY; Eagan, MN; Tempe, AZ; Auburn, WA; Livonia, MI; and Ontario, CA
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 = JIANGSU INTCO MEDICAL EQUIPMENT & SUPPLY CO., LTD.
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