Events

Retiro De Equipo (Recall) de DENTAL PROCEDURES PACKS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CARDINAL HEALTH CANADA 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
    46971
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-11-02
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Cardinal health has been informed by medtronic of a medical device correction in regards to covidien devon light gloves contained in presource kits. this correction has been initiated to update labeling of the instructions for use. medtronic advises that on rare occasion the devon light glove may split upon application to the devon light handle adapter. a split in the glove can potentially lead to a breach in the sterile barrier between the glove and the handle adapter. the following statement will be added to the instructions for use to help or staff ensures that the sterile field is maintained "after application inspect the light glove for barrier integrity".

Device

DENTAL PROCEDURES PACKS
  • Modelo / Serial
    Model Catalog: SEN30DNHKI (Lot serial: 285533); Model Catalog: SEN30DNHKI (Lot serial: 305037); Model Catalog: SBA30BRUCB (Lot serial: 315310); Model Catalog: SBA30BRUCB (Lot serial: 438644); Model Catalog: SBA30BRUCB (Lot serial: 462499); Model Catalog: SBA30ABUCE (Lot serial: 384268); Model Catalog: SBA30ABUCE (Lot serial: 393264); Model Catalog: SBA30ABUCE (Lot serial: 501923); Model Catalog: SOP30XTHDB (Lot serial: 304160); Model Catalog: SEY30STHKF (Lot serial: 283188); Model Catalog: SCV30CCCHB (Lot serial: 266131); Model Catalog: SCV30CCCHB (Lot serial: 319081); Model Catalog: SCV30CCCHB (Lot serial: 386378); Model Catalog: SCV30CCCHB (Lot serial: 440217); Model Catalog: SCV30CCCHB (Lot serial: 571646); Model Catalog: SCV30CCCHB (Lot serial: 492916)
  • Descripción del producto
    STERILE DENTAL PACK;STERILE BREAST PACK;STERILE ABDOMINAL PACK;STERILE EXTREMITY PACK;STERILE STRABISMUS PACK;STERILE CARDIAC PACK
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    HC