Events

Retiro De Equipo (Recall) de ROTAFLOW CENTRIFUGAL PUMP WITH BIOLINE

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
    74016
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-03-02
  • 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
    The manufacturer has determined that listed products may possess levels of endotoxin that exceed regulatory limits. mcp has become aware that its sampling plans for endotoxin testing on products labeled "non-pyrogenic" were not compliant with usp requirements for endotoxin on medical devices and ansi/aami st72: 2011 bacterial endotoxins - test methods routine monitoring and alternatives to batch testing. while maquet has not received any complaints of adverse events related to endotoxin exposure maquet cannot ensure devices labeled "non-pyrogenic" are without endotoxin based on a statistically valid sampling plan.

Device

ROTAFLOW CENTRIFUGAL PUMP WITH BIOLINE
  • Modelo / Serial
    Model Catalog: BEQ-RF-32 (Lot serial: all lots); Model Catalog: BO-S 2565 (Lot serial: all lots); Model Catalog: BO-S 2564 (Lot serial: all lots); Model Catalog: VKMO 31000 (Lot serial: all lots); Model Catalog: VKMO 30000 (Lot serial: all lots); Model Catalog: BO-VKMO 31000 (Lot serial: all lots); Model Catalog: BO-HQV 104802 (Lot serial: all lots); Model Catalog: BO-HQV 104100 (Lot serial: all lots); Model Catalog: BO-H 104801 (Lot serial: all lots); Model Catalog: BO-H 101111 (Lot serial: all lots); Model Catalog: BO-H65000 (Lot serial: all lots); Model Catalog: RF-32 (Lot serial: all lots); Model Catalog: BEQ-RF-32(USA) (Lot serial: all lots); Model Catalog: BEQ-H 84702 (Lot serial: all lots); Model Catalog: BEQ-H 66607 (Lot serial: all lots); Model Catalog: BEQ-H 66603 (Lot serial: all lots); Model Catalog: BEQ-H 59210 (Lot serial: all lots); Model Catalog: BEQ-H 59209 (Lot serial: all lots); Model Catalog: BEQ-H 56100 (Lot serial: all lots); Model Catalog: BEQ-H 55105 (Lot serial: all lots); Model Cata
  • Descripción del producto
    ROTAFLOW CENTRIFUGAL PUMP WITH BIOLINE;CIRCULATORY CIRCUIT SOFTLINE;QUADROX-I PEDIATRIC OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR;PERFUSION SET WITH SOFTLINE COATING;SMALL ADULT HEART LUNG PERFUSION PACK WITH SOFTLINE COATING;ROTAFLOW CENTRIFUGAL PUM
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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