Events

Rappel de CADD ADMINISTRATION SET

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SMITHS MEDICAL CANADA LTD. (SIMS).

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
    37221
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-05-04
  • 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
    Smiths is notifying users of cadd administration sets with flow stop that these listed sets may affect flow rate when used with a variety of cadd ambulatory infusion pumps. this may result in under-delivery of medication by an average additional 5.2% beyond the labeled system delivery accuracy claim of +/- 6.0%. if drug under-delivery occurs patients may not receive their full volume of medicinal product in the prescribed timeframe.

Device

CADD ADMINISTRATION SET
  • Modèle / numéro de série
    Model Catalog: 21-7324-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7333-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7323-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7322-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7322-01 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7321-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7321-01 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7383-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7383-01 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7395-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7394-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7394-01 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7391-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7391-01 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7390-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-
  • Description du dispositif
    CADD ADMINISTRATION SETS WITH FLOW STOP
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    Smiths Group Plc
  • Source
    HC