Events

Rappel de DESTINATION CAROTID GUIDING SHEATH

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par TERUMO MEDICAL 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
    144345
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-05-17
  • 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
    Certain pinnacle destination guiding sheaths containing an expiration date on or before august 31 2018 may fail to meet product specifications for insertion force of 40 grams (1.4 ounces). if a guiding sheath does not have sufficient lubricity there may be increased resistance noted during the insertion of the device into the patient especially if the patient has scar tissue or difficult anatomy.

Device

DESTINATION CAROTID GUIDING SHEATH
  • Modèle / numéro de série
    Model Catalog: RSC03 (Lot serial: >10 contact mfg); Model Catalog: RSC02 (Lot serial: >10 contact mfg); Model Catalog: RSC01 (Lot serial: >10 contact mfg); Model Catalog: 54-89006 (Lot serial: >10 contact mfg); Model Catalog: 54-89001 (Lot serial: >10 contact mfg); Model Catalog: 54-86506 (Lot serial: >10 contact mfg); Model Catalog: 54-86501 (Lot serial: >10 contact mfg); Model Catalog: 54-84501 (Lot serial: >10 contact mfg); Model Catalog: 54-74501 (Lot serial: >10 contact mfg); Model Catalog: 54-64506 (Lot serial: >10 contact mfg); Model Catalog: 54-54502 (Lot serial: >10 contact mfg); Model Catalog: RSP03 (Lot serial: >10 contact mfg); Model Catalog: RSP02 (Lot serial: >10 contact mfg); Model Catalog: RSP01 (Lot serial: >10 contact mfg); Model Catalog: 54-54501 (Lot serial: >10 contact mfg); Model Catalog: RSR17 (Lot serial: >10 contact mfg); Model Catalog: RSR16 (Lot serial: >10 contact mfg); Model Catalog: RSR15 (Lot serial: >10 contact mfg); Model Catalog: RSR14 (Lot serial: >10 contact mfg); Model Ca
  • Description du dispositif
    Destination Carotid Guiding Sheath;Destination Peripheral Guiding Sheath;Destination Renal Guiding Sheath
  • Manufacturer
    TERUMO MEDICAL CORPORATION

Manufacturer

TERUMO MEDICAL CORPORATION
  • Adresse du fabricant
    ELKTON
  • Société-mère du fabricant (2017)
    Terumo Corp.
  • Source
    HC