Events

Rappel de MED-RX EPIDURAL ANESTHESIA KIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CANADIAN HOSPITAL SPECIALTIES LTD. DOING BUSINESS AS CHS.

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
    50811
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-05-19
  • 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
    Omega laboratories the supplier of sodium chloride identified an out-of-specification (oos) stability result for the ph value at the 12 month testing interval at 25 degrees celsius. found result is 7.6 (limit is 7.0). the product shelf life is 48 months and the lot is out-of-specification before expiry. med-rx anthesia kits contain this component.

Device

MED-RX EPIDURAL ANESTHESIA KIT
  • Modèle / numéro de série
    Model Catalog: 80-8005 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8004 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8006 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8018 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8022 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8023 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8025 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8026 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8033 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8034 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8042 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8060N (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8066 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8074 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8082 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8040 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog:
  • Description du dispositif
    MED-RX ANESTHESIA KIT
  • Manufacturer
    CANADIAN HOSPITAL SPECIALTIES LTD. DOING BUSINESS AS CHS

Manufacturer

CANADIAN HOSPITAL SPECIALTIES LTD. DOING BUSINESS AS CHS