Events

Recall of Device Recall McKesson SunMark Performance Wheelchair, 22" Seat

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cypress Medical Products, Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    31147
  • Event Risk Class
    Class 2
  • Event Number
    Z-0646-05
  • Event Initiated Date
    2004-05-03
  • Event Date Posted
    2005-03-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37292
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Wheelchair, Mechanical - Product Code IOR
  • 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.
  • 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.

Device

Device Recall McKesson SunMark Performance Wheelchair, 22" Seat
  • Model / Serial
    reorder no. 16-7952, 16-7953, 16-7954, all serial numbers
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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 Description
    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
  • Manufacturer
    Cypress Medical Products, Ltd.

Manufacturer

Cypress Medical Products, Ltd.
  • Manufacturer Address
    Cypress Medical Products, Ltd., 1202 S. Rte 31, McHenry IL 60050
  • Source
    USFDA