Events

Retiro De Equipo (Recall) de Device Recall McKesson SunMark Performance Wheelchair, 16" Seat

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Cypress Medical Products, Ltd..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    31147
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0643-05
  • Fecha de inicio del evento
    2004-05-03
  • Fecha de publicación del evento
    2005-03-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-08-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37289
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Wheelchair, Mechanical - Product Code IOR
  • Causa
    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.
  • Acción
    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, 16" Seat
  • Modelo / Serial
    reorder no. 16-7910, 16-7911, 16-7912, 16-7913, 16-7914, all serial numbers
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    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
  • Descripción del producto
    Manual Mechanical Wheelchair, 16'' 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 16-7910: Fixed Full Arm, Swing Footrest || reorder 16-7911: Fixed Full Arm, Elevating Adjustable Legrest || reorder 16-7912: Removable Desk Arm, Swing Footrest || reorder 16-7913: Removable Desk Arm, Elevating Adjustable Legrest || reorder 16-7914: Removable Full Arm, Elevating Adjustable Legrest
  • Manufacturer
    Cypress Medical Products, Ltd.

Manufacturer

Cypress Medical Products, Ltd.
  • Dirección del fabricante
    Cypress Medical Products, Ltd., 1202 S. Rte 31, McHenry IL 60050
  • Source
    USFDA