Events

Retiro De Equipo (Recall) de VAGINAL DELIVERY 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
    74350
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-06-20
  • 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
    Bd canada issued a product advisory notice regarding the bd vacutainer luer adapter cat. no. 367290 and bd vacutainer specimen collection assembly with bd blunt plastic cannula cat. no. 303380. bd has received reports of blood leakage and low draw volume associated with the bd vacutainer luer adapter and bd vacutainer specimen collection assembly with bd blunt plastic cannula. in a limited number of instances the gray rubber sleeve on the cannula inside of the vacutainer tube holder has been reported to disengage from the cannula or permit small amounts of blood leakage during the collection of multiple tubes. the bd vacutainer luer adapter cat. no. 367290 is a component in the medline vaginal delivery cds module cds982079b.

Device

VAGINAL DELIVERY CDS PACK
  • Modelo / Serial
    Model Catalog: CDS982079B (Lot serial: 12EB1869); Model Catalog: CDS982079B (Lot serial: 12EB0522); Model Catalog: CDS982079B (Lot serial: 12CD3095); Model Catalog: CDS982079B (Lot serial: 12EB2281); Model Catalog: CDS982079B (Lot serial: 12EB2222)
  • Descripción del producto
    Vaginal Delivery CDS Module
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION