Events

Rappel de ANIMAS 2020 INSULIN INFUSION PUMP (VARIOUS COLOURS)

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON 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
    28018
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2010-03-23
  • 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
    Animas 2020 and onetouch ping insulin pumps that have sustained external impact may have damaged the force sensor which can cause the whole cartridge of insulin to be dispensed during the "load cartridge" step of the priming sequence. failure to follow safety instructions and disconnect the infusion set from the body during the "rewind load and prime" steps can lead to unintended delivery of insulin.

Device

ANIMAS 2020 INSULIN INFUSION PUMP (VARIOUS COLOURS)
  • Modèle / numéro de série
    Model Catalog: 200-260-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 100-385-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-262-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-263-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-264-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-265-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-371-00 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-370-00 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-372-00 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-374-00 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-375-00 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 100-380-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 100-381-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 100-382-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 100-384-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Mod
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Description du dispositif
    Animas 2020 Insulin Pump
  • Manufacturer
    LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC.

Manufacturer

LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC.