Rappel de HOSPIRA RECEPTAL LINERS - 1500 ML

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par HOSPIRA HEALTHCARE CORPORATION.

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
    42070
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-10-02
  • Pays de l'événement
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notes supplémentaires dans les données
  • Cause
    Hospira became aware that customers may be using incorrectly sized receptal liners with receptal canisters. it is possible that if the incorrectly sized liners are used with different sized canisters the lid may not fit and the vaccum/suction will not be sufficient and/or consistent.

Device

  • Modèle / numéro de série
    Model Catalog: 43025002 (Lot serial: All lot numbers); Model Catalog: 43044005 (Lot serial: All lot numbers); Model Catalog: 43044006 (Lot serial: All lot numbers); Model Catalog: 43042002 (Lot serial: All lot numbers); Model Catalog: 43042001 (Lot serial: All lot numbers); Model Catalog: 43024001 (Lot serial: All lot numbers); Model Catalog: 0G661001 (Lot serial: All lot numbers); Model Catalog: 43027002 (Lot serial: All lot numbers); Model Catalog: 43023001 (Lot serial: All lot numbers); Model Catalog: 43043003 (Lot serial: All lot numbers); Model Catalog: 43027001 (Lot serial: All lot numbers); Model Catalog: 0G905001 (Lot serial: All lot numbers); Model Catalog: 43043001 (Lot serial: All lot numbers); Model Catalog: 43044002 (Lot serial: All lot numbers)
  • Description du dispositif
    Hospira Receptal Liners - 1500mL
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    SAINT-LAURENT
  • Société-mère du fabricant (2017)
  • Source
    HC