Events

Rappel de CADD-PRIZM HIGH VOLUME 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
    28217
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-03-21
  • 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 medical has received a total of 22 complaints regarding occlusions/high pressure alarms experienced with cadd high volume administration sets 21-7081v-01 and 21-7381-01. please note 21-7081v-01 is not sold in canada. investigation of this issue has identified the root cause to be related to the incorrect filter size being used in one lot of finished goods. investigation to the root cause identified that the supplier had supplied a 0.2u filter instead of a 1.2 u filter. the 0.2u filter does not allow for the passage of lipids in tpn solution whereas the 1.2u filter does allow the passage of lipids. an indepth investigation concluded that the incorrect filter size was limited to 2 component part lot numbers which were put into production of 2 smiths medical finished goods lot numbers. only 1 lot number 21x221 applies to canadian product.

Device

CADD-PRIZM HIGH VOLUME ADMINISTRATION SET
  • Modèle / numéro de série
    Model Catalog: 21-7381-01 (Lot serial: 21X221)
  • Description du dispositif
    CADD High Volume Administration Sets
  • 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