Events

Retiro De Equipo (Recall) de POWERPICC SOLO2 CATHETER SHERLOCK STYLET AND MICROINTRODUCER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BARD CANADA 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
    125403
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-03-20
  • 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
    Bard has notified customers of the potential for scalpel cut/stick injury following a change in the safety scalpel component in some bard peripherally inserted central catheter (picc) kits. for users accustomed to the previous scalpel (bard-parker safety scalpel) a risk of improper use of the new safe-cut safety scalpel was noted. the customer letter described important differences in operation between the previous and current scalpel products.

Device

POWERPICC SOLO2 CATHETER SHERLOCK STYLET AND MICROINTRODUCER
  • Modelo / Serial
    Model Catalog: 1396118 (Lot serial: REYD0312); Model Catalog: 1295118 (Lot serial: REYD0312); Model Catalog: 1194118 (Lot serial: REYD0312); Model Catalog: 1396118 (Lot serial: REYD0126); Model Catalog: 1295118 (Lot serial: REYD0126); Model Catalog: 1194118 (Lot serial: REYD0126); Model Catalog: 1396118 (Lot serial: REYF0212); Model Catalog: 1295118 (Lot serial: REYF0212); Model Catalog: 1194118 (Lot serial: REYF0212); Model Catalog: 1396118 (Lot serial: REYE2229); Model Catalog: 1295118 (Lot serial: REYE2229); Model Catalog: 1194118 (Lot serial: REYE2229); Model Catalog: 1396118 (Lot serial: REYE1795); Model Catalog: 1295118 (Lot serial: REYE1795); Model Catalog: 1194118 (Lot serial: REYE1795); Model Catalog: 1396118 (Lot serial: REYD2021); Model Catalog: 1295118 (Lot serial: REYD2021); Model Catalog: 1194118 (Lot serial: REYD2021); Model Catalog: 1396118 (Lot serial: REYD1015); Model Catalog: 1295118 (Lot serial: REYD1015); Model Catalog: 1194118 (Lot serial: REYD1015); Model Catalog: 1396118 (Lot serial:
  • Descripción del producto
    POWERPICC SOLO2 WITH SHERLOCK STYLET
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.