Events

Retiro De Equipo (Recall) de ARGON Bone Marrow I-type aspirate/biopsy needles & ARGON Trap-Lok Bone Marrow biopsy needles

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Culpan Medical 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-00541-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-19
  • 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-00541-1
  • 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
    Some of these products may have a hole in the blister pack, which may compromise the sterility of the product inside the tray. invasive medical procedures conducted using non-sterile products could result in an infection for the patient. to date, there have been no reports of patient harm or infection attributed to this issue.
  • Acción
    Customers are asked to check their inventory and place affected stock into quarantine. Culpan Medical will arrange to have quarantined stock collected. Unaffected products are available to replace any returned units. This action has been closed-out on 08/08/2016.

Device

ARGON Bone Marrow I-type aspirate/biopsy needles & ARGON Trap-Lok Bone Marrow biopsy needles
  • Modelo / Serial
    ARGON Bone Marrow I-type aspirate/biopsy needles & ARGON Trap-Lok Bone Marrow biopsy needlesProduct codes: BMHN1304VX, DBMNI1501, DBMNI1601, DBMNJ0804TL, DBMNJ1104TL, DBMNI1601Lot Numbers: 11095380, 11095842, 11098707, 11089370, 11096115, 11088295, 11094182, 11088597, 11090527ARTG Number: 223222
  • Manufacturer
    Culpan Medical Pty Ltd

Manufacturer

Culpan Medical Pty Ltd