Events

Retiro De Equipo (Recall) de SENSICARE GREEN WITH ALOE SURGICAL GLOVES

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
    107805
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-10-27
  • 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
    The reason for this recall is the result of a confirmed us customer complaint of an open seal on the top portion of the package. medline confirmed the customer complaint and promptly put all other inventory with this lot number on quarantine for further investigation. no other packages from this lot were confirmed to have open seals during the investigation. as a precautionary measure medline is issuing a recall for this specific lot of gloves.

Device

SENSICARE GREEN WITH ALOE SURGICAL GLOVES
  • Modelo / Serial
    Model Catalog: MSG1285 (Lot serial: 701893369485)
  • Descripción del producto
    SENSICARE GREEN WITH ALOE SURGICAL GLOVES
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION