Recall Z-0645-05 ยท IOR Wheelchair, Mechanical
Cypress Medical Products, Ltd.
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 Adj
| Date | Mar 22, 2005 (initiated May 3, 2004) |
| Status | Terminated |
| Reason | 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. |
| 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 | 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; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002670 | EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR Jiangsu Intco Medical Equipment & Supply Co., Ltd., Oct 11, 2000 |