Events

Rappel de CUSTOM PACK WITH SOFTLINE

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
    17225
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-08-08
  • 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
    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
  • Modèle / numéro de série
    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
  • Description du dispositif
    CUSTOM PACK WITH SOFTLINE
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    HC