Events

Rappel de ROTAFLOW CENTRIFUGAL PUMP WITH BIOLINE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MAQUET-DYNAMED INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    74016
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-03-02
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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
  • Description du dispositif
    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.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    HC