Events

Retiro De Equipo (Recall) de Safil Sutures Safil Violet 1 (4) 70cm HR26 Safil Violet 4/0 (1,5) 70cm HR22 Safil Violet Undyed 4/0 (1,5) 70cm, DS24 Safil Violet Undyed 2/0 (3) 70cm HR26 Safil Violet 3/0 (2) 70cm, HR22 Safil Violet 2 (5) 70cm HR 37S Safil Violet 2 (5) 70cm HR37S

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por B Braun 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-2018-RN-00737-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-20
  • 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-2018-RN-00737-1
  • 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
    B. braun has been identified that some of the items in specific batches have damaged packaging which may affect the sterility of the products. no specific monitoring of patients is recommended at this time.To date, there have been no reports of any adverse patient outcome which could be associated with this potential sterility issue.
  • Acción
    B. Braun is requesting customers: 1. Identify, quarantine and return affected devices; 2. Do not use affected devices anymore; 3. Patients with affected devices in use should be monitored carefully; 4. Inform the responsible personnel in the relevant facilities; and 5. Confirm receipt of the correspondence as per the instructions given in the Customer Letter.

Device

Safil Sutures Safil Violet 1 (4) 70cm HR26 Safil Violet 4/0 (1,5) 70cm HR22 Safil Violet Undyed 4...
  • Modelo / Serial
    Safil Sutures Safil Violet 1 (4) 70cm HR26Safil Violet 4/0 (1,5) 70cm HR22Safil Violet Undyed 4/0 (1,5) 70cm, DS24Safil Violet Undyed 2/0 (3) 70cm HR26Safil Violet 3/0 (2) 70cm, HR22Safil Violet 2 (5) 70cm HR 37SSafil Violet 2 (5) 70cm HR37SMultiple Item Codes and Batch NumbersARTG Number: 222738
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd