Events

Retiro De Equipo (Recall) de CBCII AMBULATING BULB (PK10), 1/8 TROCAR W/DRAIN (PK10), 1/4 TROCAR W/DRAIN (PK10)CBCII AMBULATING BULB (PK10)

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

¿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-2015-RN-00284-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-30
  • 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-2015-RN-00284-1
  • 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.
  • Notas adicionales en la data
  • Causa
    The manufacturer have identified that the boxes used to ship the products were too small for the number of products (10 units) packaged within the box. the units packed into the shipper experienced bending and folding of the pouches. this can increase the risk of breaching the outer pouch. note that only a breach in the exterior pouch was detected – the interior pouch was not breached. a breach would have to develop in both pouches before the product would become unsterile.
  • Acción
    Stryker is requesting their customer to discontinue use and quarantine the affected product. A Stryker Representative will organise for the removal of any affected units found and a credit will be given for these items.

Device

CBCII AMBULATING BULB (PK10), 1/8 TROCAR W/DRAIN (PK10), 1/4 TROCAR W/DRAIN (PK10)CBCII AMBULATIN...
  • Modelo / Serial
    CBCII AMBULATING BULB (PK10), 1/8 TROCAR W/DRAIN (PK10), 1/4 TROCAR W/DRAIN (PK10)CBCII AMBULATING BULB (PK10)Catalogue Number: 0225028852Lot Numbers: 10337012, 102810121/8 TROCAR W/DRAIN (PK10)Catalogue Number: 0215018000Lot Numbers: 13191012, 11088012,11125012, 112040121/4 TROCAR W/DRAIN (PK10)Catalogue Number: 0215019000Lot Number: 12235012ARTG Numbers: 140544, 233315
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA