Events

Retiro De Equipo (Recall) de CYSTO-CARE - PROCEDURE PAK

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por COLOPLAST CANADA CORPORATION.

¿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
    63922
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-01-26
  • 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
    Trays contain sterile lubricant and/or alcohol prep pads manufactured by triad group. on december 22 2010 triad issued a recall notice. the recall is due to concerns expressed by the us fda regarding the validation of the gamma radiation sterilization cycles for these products. a recall was also issued by triad involving alcohol prep pads alcohol swabs and alcohol swabsticks due to concerns about potential contamination with bacillus cereus.

Device

CYSTO-CARE - PROCEDURE PAK
  • Modelo / Serial
    Model Catalog: UT1002 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: UT 8140 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: UT 7030 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: UT 7010 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: UT1002 (Lot serial: >10 CONTACT MFR. OR IMP.); Model Catalog: UT1001 (Lot serial: >10 CONTACT MFR. OR IMP.); Model Catalog: UT 8140 (Lot serial: >10 CONTACT MFR. OR IMP.); Model Catalog: UT 7030 (Lot serial: >10 CONTACT MFR. OR IMP.); Model Catalog: UT 7010 (Lot serial: >10 CONTACT MFR. OR IMP.); Model Catalog: UT1001 (Lot serial: > 10 lot numbers contact mfg)
  • Descripción del producto
    CYSTO-CARE UROLOGICAL PROCEDURE TRAYS
  • Manufacturer
    COLOPLAST CANADA CORPORATION

Manufacturer

COLOPLAST CANADA CORPORATION
  • Dirección del fabricante
    CONCORD
  • Empresa matriz del fabricante (2017)
    Coloplast A/S
  • Source
    HC