Events

Rappel de CONTACT DETACH INFUSION SETS

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
    90242
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-11-24
  • 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
    Manufacturer has identified an increase in reports of the tubing becoming detached at the connect/disconnect location. if tubing detachment occurs insulin delivery is interrupted and the pump will not alarm to notify patients. the interruption of insulin delivery can cause hyperglycemia which if left untreated can result in diabetic ketoacidosis (dka). dka is a serious condition that can cause a severe impact to health including death. symptoms of dka may include nausea vomiting shortness of breath and excess thirst/urination. manufacturer is advising patients to seek medical attention immediately if they are experiencing any of these symptoms.

Device

CONTACT DETACH INFUSION SETS
  • Modèle / numéro de série
    Model Catalog: 10090503 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10000601 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10000602 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10000603 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10000600 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10090502 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10090501 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10090500 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10024005 (Lot serial: 5052070); Model Catalog: 10024004 (Lot serial: 5052070); Model Catalog: 10024003 (Lot serial: 5052070); Model Catalog: 10024001 (Lot serial: 5052070); Model Catalog: 89-060-2522 (Lot serial: 5052070); Model Catalog: 10024005 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10024004 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10024003 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10024001 (Lot serial: > 10 numbers contact mfg); Model Catalog: 89
  • Description du dispositif
    Contact Detach Infusion Sets
  • Manufacturer
    LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC.

Manufacturer

LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC.