Manual Mechanical Wheelchair, 22'' seat, , maximum patient weight: 350 lbs.; Marketed by McKesson Corporation, McKesson
FDA device recall Z-0646-05 · posted 2005-03-22 · Terminated
Recall details
- Recalling firm
- Cypress Medical Products, Ltd.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IOR
- Quantity affected
- 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
- Date initiated
- 2004-05-03
- Date posted
- 2005-03-22
- Date terminated
- 2005-08-19
- Location
- McHenry, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR (K002670) | Jiangsu Intco Medical Equipment & Supply Co., Ltd. | 2000-10-11 |