Events

Retiro De Equipo (Recall) de GENERAL LAPAROSCOPY CDS PACK

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MEDLINE 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
    20754
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-07-07
  • 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
    Medline has received a recall notice from conmed regarding their core reposable trumpet handpiece (conmed p/n cd8300). these handpieces are used as a component in several cds modules sold by medline canada. conmed is issuing this recall because the individual package seal may be compromised which could potentially affect the integrity of the sterile barrier. the handpieces are to be removed from the packs upon opening and discarded. the medline pack has been terminally sterilized therefore the remaining components within the pack are safe to use.

Device

GENERAL LAPAROSCOPY CDS PACK
  • Modelo / Serial
    Model Catalog: CDS983989 (Lot serial: > 10 numbers contact mfg.); Model Catalog: CDS983989A (Lot serial: > 10 numbers contact mfg.); Model Catalog: CDS984007B (Lot serial: > 10 numbers contact mfg.); Model Catalog: CDS984007 (Lot serial: > 10 numbers contact mfg.); Model Catalog: CDS984007A (Lot serial: > 10 numbers contact mfg.); Model Catalog: CDS983995 (Lot serial: 13BB3793); Model Catalog: CDS983995 (Lot serial: 13BB9766); Model Catalog: CDS983995 (Lot serial: 13MB1943); Model Catalog: CDS983995 (Lot serial: 13SB1980); Model Catalog: CDS983995 (Lot serial: 12JB8722)
  • Descripción del producto
    GENERAL LAPAROSCOPY CDS PACK;MAJOR GYN LAPAROSCOPY CDS PACK;MINOR GYN LAPAROSCOPY CDS PACK
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION