Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0646-05

Manual Mechanical Wheelchair, 22'' seat, , maximum patient weight: 350 lbs.; Marketed by McKesson...

Cypress Medical Products LLC / initiated 2004-05-03 / Terminated

Cypress Medical Products, Ltd. began a recall of Manual Mechanical Wheelchair, 22'' seat, , maximum patient weight: 350 lbs.; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228... on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0646-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Cypress Medical Products LLC
Product
Manual Mechanical Wheelchair, 22'' 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 16-7952: Removable Desk Arm, Swing Footrest reorder 16-7953: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7954: Removable Full Arm, Elevating Adjustable Legrest
Product code
IOR Wheelchair, Mechanical
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 root cause
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
13 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
Product codes and lots
reorder no. 16-7952, 16-7953, 16-7954, all serial numbers