Events

Retiro De Equipo (Recall) de Various Tissu-Trans Products

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

¿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-01000-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-29
  • 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-01000-1
  • 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
    Results from a visual examination performed on the packaging by the manufacturer shippert medical technologies has revealed that the seal integrity of specific tissu-trans product sterile packages cannot be assured prior to usage without a visual inspection of the seal. to date, shippert has not received any customer complaints or reports of serious injuries and/or deaths due to the lack of sterility.
  • Acción
    1. Remove all affected products and store them in a separate area. These products must not come into clinical use. 2. Forward this letter to all staff members that need to be aware of this information letter and the initiated recall. 3. Contact Precise medical supplies customer service for any additional questions regarding return of the products. 4. Replacement product will be issued and sent for returned products.

Device

Various Tissu-Trans Products
  • Modelo / Serial
    Various Tissu-Trans ProductsMega Trans 1500Model Number: SH 3-TT-1500Lot Numbers: 61288, 61464Tissu Trans 100ccModel Number: SH 3-TT-FILTRON 100Lot Numbers: 12018, 12109Tissu Trans 1000Model Number: SH 3-TT-FILTRON 1000Lot Numbers: 12004, 61235Tissu Trans 250Model Number: SH 3-TT-FILTRON 250Lot Numbers: 12019, 61286, 61421Filtron 500Model Number: SH 3-TT-FILTRON 500Lot Numbers: 12002, 12046, 61363ARTG Number: 181259
  • Manufacturer
    Precise Medical Supplies

Manufacturer

Precise Medical Supplies
  • Source
    DHTGA