Events

Retiro De Equipo (Recall) de U-100 Insulin Syringe 0.5mL 27G and 29G

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Terumo 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-00171-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-23
  • 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-00171-1
  • 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
    Taechang industrial is initiating a recall of all lot numbers of terumo branded u-100 insulin syringe with a capacity of 0.5ml x 27g and 29g due to incorrect information contained on the device peel pack.The statement:"0.5ml single use syringe for 100 units or less in two unit increments"is incorrect and should state:"0.5ml single use syringe for 50 units or less in one unit increments"in essence, the 0.5ml peel packs have been inadvertently printed with information intended for the 1.0ml peel pack. the printing on the syringes themselves is correct.
  • Acción
    Terumo is requesting customers: 1. Review the supplied urgent medical device recall (permanent removal) notification, inspect all stock on hand and quarantine affected lot numbers prior to return as per the instructions given in the customer letter. Ensure all relevant staff are made aware of this recall; 2.If any of the recalled product could have been transferred from your facility to another, please immediately notify that facility know of this recall; 3.Where possible, return all affected stock to your supply department for consolidated return to Terumo Australia as per the instructions given; and 4.Terumo will be providing credit for all returned stock. Replacement stock will not be automatically issued. Please process a new order if more stock is required.

Device

U-100 Insulin Syringe 0.5mL 27G and 29G
  • Modelo / Serial
    U-100 Insulin Syringe 0.5mL 27G and 29G Lot Numbers for product SS*05M2713KA: 7D700, 7E700, 7F731, 7G719, 7I701, 6H713,6K700 Lot Numbers for product SS*05M2913KA : 7A713, 7G720, 7I7012, 7A713, 7B728, 6F700, 6F706Multiple Lot Numbers (see attached)ARTG: 234082 (Terumo Australia Pty Ltd - Insulin syringe, fixed-needle)
  • Manufacturer
    Terumo Australia Pty Ltd

Manufacturer

Terumo Australia Pty Ltd