Manual Mechanical Wheelchair, 24'' seat, , maximum patient weight: 450 lbs.; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in China; the wheelchairs were sold in the following configurations: reorder 16-7920: Removable Desk Arm, Swing Footrest reorder 16-7921: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7922: Removable Full Arm, Elevating Adjustable Legrest
This recall has been terminated (originally issued March 22, 2005).
- Company
- Cypress Medical Products, Ltd.
- Recall Initiated
- May 3, 2004
- Posted
- March 22, 2005
- Terminated
- August 19, 2005
- Recall Number
- Z-0644-05
- Quantity
- 59 chairs
- Firm Location
- McHenry, IL
- Official Source
- View on FDA website ↗
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.
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
Lot / Code Info
reorder no. 16-7920, 16-7921, 16-7922, all serial numbers
Root Cause
Other
Action Taken
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.