Events

Retiro De Equipo (Recall) de Various Disposable Catheter Mounts Straight Swivel Swivel Elbow Straight Adaptors Elbow Double Swivel Elbow

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Swirl Technologies Pty Ltd T/A Parker Healthcare.

¿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-01168-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-11
  • 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-01168-1
  • 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
    During a regular qa inspection, parker healthcare noticed an irregularity in the expandable tubing of specific tube/mask breathing circuit single-use connectors (disposable catheter mounts). to date, no injury or illness has been reported.
  • Acción
    1. Complete and return the supplied acknowledgement form. If any of the affected products have been transferred from your facility to another, immediately inform other supplied facilities of this Recall. 2. Isolate the unit(s) from the affected Batch(es)/Lot(s) and contact Parker Healthcare Customer Service Team on 1300 361 201 or via email sales@parkerhealth.com.au to arrange the return of stock and the supply of replacement stock. Returned stock will be replaced with unaffected batches at no cost.

Device

Various Disposable Catheter Mounts Straight Swivel Swivel Elbow Straight Adaptors Elbow Double Sw...
  • Modelo / Serial
    Various Disposable Catheter MountsStraight SwivelSwivel ElbowStraight AdaptorsElbowDouble Swivel ElbowMultiple Product Names, Part Numbers and Batch NumbersARTG Number: 188096
  • Manufacturer
    Swirl Technologies Pty Ltd T/A Parker Healthcare

Manufacturer

Swirl Technologies Pty Ltd T/A Parker Healthcare
  • Source
    DHTGA