Events

Retiro De Equipo (Recall) de CUSTOM PACK WITH SOFTLINE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MAQUET-DYNAMED 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
    17225
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-08-08
  • 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
    New more stringent internal testing conducted by maquet cardiopulmonary to reduce the possibility of any quality issues in the field has indicated that specific oxygenator lots may not meet product specifications. specifically internal testing indicates that the outlet or/and inlet connector port of the unit may dislodge and separate from the main body of the oxygenator. please note that this recall pertains to specific lots of oxygenators. users need to continue to use the reusable mechanical clamp provided by maquet with all remaining maquet quadrox oxygenators currently in distribution. the specific lots within this recall may have an increased tendency for separation as indicated in the internal testing results.

Device

CUSTOM PACK WITH SOFTLINE
  • Modelo / Serial
    Model Catalog: BO-HQV 46901 (Lot serial: 92087670); Model Catalog: HQV 56103 (Lot serial: 70091907); Model Catalog: HQV 55806 (Lot serial: 70091907); Model Catalog: HQV 55806 (Lot serial: 92087265); Model Catalog: HQV 56103 (Lot serial: 92087265); Model Catalog: HQV 55806 (Lot serial: 92084433); Model Catalog: HQV 56103 (Lot serial: 92084433); Model Catalog: HQV 55806 (Lot serial: 92089326); Model Catalog: HQV 56103 (Lot serial: 92088079); Model Catalog: HQV 55806 (Lot serial: 92088079); Model Catalog: HQV 56103 (Lot serial: 92089326); Model Catalog: HMO 71000 (Lot serial: 70082790); Model Catalog: HMO 70000 (Lot serial: 70082790); Model Catalog: BE-PLS 2051 (Lot serial: 70075041); Model Catalog: HMO 71000 (Lot serial: 70082328); Model Catalog: HMO 70000 (Lot serial: 70082328); Model Catalog: VKMO 70000 (Lot serial: 70081881); Model Catalog: BEQ-HQV 46900 (Lot serial: 92098557); Model Catalog: BEQ-HQV 46900 (Lot serial: 92084424); Model Catalog: BEQ-HQV 46900 (Lot serial: 92096512); Model Catalog: BEQ-HQV 46
  • Descripción del producto
    CUSTOM PACK WITH SOFTLINE
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    HC