Events

Retiro De Equipo (Recall) de Jackson-Pratt Perforated and Hemaduct Wound Drainage Systems

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medline International Two 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-2017-RN-00565-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-03
  • 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-2017-RN-00565-1
  • 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
    Medline is recalling specific jackson-pratt perforated and hemaduct wound drainage systems, due to a potential breach of sterility in the packaging. in a small percentage of product (approximately 1.6%), the inner packaging (polybag) is caught in the seal area of the outer tyvek pouch, potentially compromising the sterility of the package contents. use of impacted products could result in an increased risk of infection. to date, the manufacturer has not received any complaints or reports of infection associated with this issue.
  • Acción
    Medline is advising customers to remove affected codes/lots from their stock holdings and to also segregate affected units for Medline to collect. Medline will organise pick-up of the affected stock and a credit note will be issued.

Device

Jackson-Pratt Perforated and Hemaduct Wound Drainage Systems
  • Modelo / Serial
    Jackson-Pratt Perforated and Hemaduct Wound Drainage SystemsProduct Codes: JP-HUR101, SU130-1308, SU130-1309, SU130-1310, SU130-1311 and SU130-1411 Batch Numbers: 1161468, 1161228, 1161396, 1161413, 1161460, 1161461, 1161230, 1161399, 1161247, 1161251, 1161622, 1161623 and 1161253ARTG Number: 169567
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd