Events

Retiro De Equipo (Recall) de SARNS DUAL-STAGE MALLEABLE VENOUS RETURN CATHETER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por RYAN MEDICAL DISTRIBUTORS INC..

¿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
    67996
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-07-23
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    During an inspection of finished product terumo cardiovascular systems (terumo cvs) identified the presence of loose fiber particulate that exceeded specification for the finished sarns and terumo cannulae. terumo cvs has not received any reports of loose particulate during clinical use. tcvs has decided to remove all affected lots that were distributed.

Device

SARNS DUAL-STAGE MALLEABLE VENOUS RETURN CATHETER
  • Modelo / Serial
    Model Catalog: 4936 (Lot serial: >100 numbers contact mfg.); Model Catalog: 4881 (Lot serial: >10 numbers contact mfg.); Model Catalog: 9453 (Lot serial: >10 numbers contact mfg.); Model Catalog: 4951 (Lot serial: >100 numbers contact mfg.); Model Catalog: 4949 (Lot serial: >100 numbers contact mfg.); Model Catalog: 5767 (Lot serial: >100 numbers contact mfg.); Model Catalog: 5762 (Lot serial: >100 numbers contact mfg.); Model Catalog: 5761 (Lot serial: >100 numbers contact mfg.); Model Catalog: 813547 (Lot serial: >100 numbers contact mfg.); Model Catalog: 813546 (Lot serial: >100 numbers contact mfg.); Model Catalog: 813544 (Lot serial: >100 numbers contact mfg.); Model Catalog: 4950 (Lot serial: >1000 numbers contact mfg.); Model Catalog: 4948 (Lot serial: >1000 numbers contact mfg.); Model Catalog: 15949 (Lot serial: >10 numbers contact mfg.); Model Catalog: 813588 (Lot serial: >100 numbers contact mfg.); Model Catalog: 813586 (Lot serial: >100 numbers contact mfg.); Model Catalog: 813583 (Lot serial: >1
  • Descripción del producto
    Sarns Dual-Stage Malleable Venous Return Catheter
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.