Events

Rappel de DISCPAC TIP CAPS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BAXTER 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
    44673
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-12-24
  • 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
    During a label review it was identified that the single and case label templates for discpac tip caps did not include the latex symbol. discpacs were shipped with a missing latex symbol on both single and case label artwork. the ifu correctly identifies the latex content. the heat shrink tape used on the discpac package is the only component that contains latex. the tape does not come into direct contact with the tip caps but must be peeled away and removed to access the self-righting tip caps.

Device

DISCPAC TIP CAPS
  • Modèle / numéro de série
    Model Catalog: H938672025 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938678100 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938679025 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938679100 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H93868100 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938690025 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H93869025 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H93869100 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938677100 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938677025 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938676100 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938676025 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938674100 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938674025 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938673100 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938673025 (Lot seria
  • Description du dispositif
    DISCPAC TIP CAPS
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION