Z-0642-05
Manual Mechanical Wheelchair, 18'' seat, , maximum patient weight: 250 lbs.; Marketed by McKesson...
Cypress Medical Products LLC / initiated 2004-05-03 / Terminated
Cypress Medical Products, Ltd. began a recall of Manual Mechanical Wheelchair, 18'' seat, , maximum patient weight: 250 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-0642-05
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Cypress Medical Products LLC
- Product
- Manual Mechanical Wheelchair, 18'' seat, , maximum patient weight: 250 lbs.; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in China; the wheelchairs were sold in the following configurations: reorder 16-7901: Fixed Full Arm, Fixed Footrest reorder 16-7902: Fixed Full Arm, Swing Footrest reorder 16-7903: Fixed Full Arm, Elevating Adjustable Legrest reorder 16-7904: Removable Desk Arm, Swing Footrest reorder 16-7905: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7906: 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
- 251 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. 16-7901, 16-7902, 16-7903, 16-7904, 16-7905, 16-7906, all serial numbers
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