Events

Retiro De Equipo (Recall) de Device Recall Comfort Sling Plus Model 300

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 Hill-Rom, Inc..

¿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
    57861
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1396-2011
  • Fecha de inicio del evento
    2011-02-09
  • Fecha de publicación del evento
    2011-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97603
  • 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
    Non-AC-Powered Patient Lift - Product Code FSA
  • Causa
    Slings were improperly assembled and the loops that are used to support the sling when hung from a lift were too long, potentially putting the patient being lifted at risk of falling out.
  • Acción
    The firm sent an URGENT MEDICAL DEVICE RECALL notice dated 02/09/2011 to Facility Risk Manager/Facility Administrators. The letter Identified the affected product, explained the recall situation, and asked firms to check their facility for the affected serial numbers. Consignees were asked to return the recalled products, and a replacement sling would be sent to them. Customers can contact Hill-Rom Technical Support at 800-445-3720, if they have any questions concerning this matter.

Device

Device Recall Comfort Sling Plus Model 300
  • Modelo / Serial
    Serial Numbers: A032220, A032221, A032222, A032223, A032224, A032227, A032228 and A032229.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, Switzerland, Germany, Denmark, Finland, France, UK, Italy, Netherlands, Sweden, and Canada.
  • Descripción del producto
    Liko Comfort Sling Plus Model 300, Part number 35300305, Size Medium, LIKO, Sweden. Liko a Hill-Rom Company. || Enables a comfortable sitting position and adapts to the patient without the need for individual adjustments when transferring a patient with a lift.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Dirección del fabricante
    Hill-Rom, Inc., 125 E Pearl St, 1069 State Route 46 East, Batesville IN 47006
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA