Events

Retiro De Equipo (Recall) de 1000mL Receptal System (waste disposable suction system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Hospira Pty Limited.

¿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
    RC-2013-RN-00413-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-10
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00413-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
  • Causa
    Hospira have received customer reports where the 1000ml receptal system is not achieving vacuum and/or improper fit of the pvc liner.
  • Acción
    Hospira is advising their customers to quarantine all 1000mL Receptal System units and use an alternative Receptal Liner (1500 mL or 2000 mL). If alternative devices are not available Hospira has provided work around instructions to reduce the safety risk to patients due to any reduction or failure of vacuum.

Device

1000mL Receptal System (waste disposable suction system)
  • Modelo / Serial
    1000mL Receptal System (waste disposable suction system)Canister 1000 mLInventory number: 434490411List number: 43449 PVC Liner 1000 mLInventory number: 0L2129701List number: L212A52
  • Manufacturer
    Hospira Pty Limited

Manufacturer

Hospira Pty Limited
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    DHTGA