Events

Rappel de SARNS DUAL-STAGE MALLEABLE VENOUS RETURN CATHETER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par RYAN MEDICAL DISTRIBUTORS INC..

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
    67996
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-07-23
  • 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 an inspection of finished product terumo cardiovascular systems (terumo cvs) identified the presence of loose fiber particulate that exceeded specification for the finished sarns and terumo cannulae. terumo cvs has not received any reports of loose particulate during clinical use. tcvs has decided to remove all affected lots that were distributed.

Device

SARNS DUAL-STAGE MALLEABLE VENOUS RETURN CATHETER
  • Modèle / numéro de série
    Model Catalog: 4936 (Lot serial: >100 numbers contact mfg.); Model Catalog: 4881 (Lot serial: >10 numbers contact mfg.); Model Catalog: 9453 (Lot serial: >10 numbers contact mfg.); Model Catalog: 4951 (Lot serial: >100 numbers contact mfg.); Model Catalog: 4949 (Lot serial: >100 numbers contact mfg.); Model Catalog: 5767 (Lot serial: >100 numbers contact mfg.); Model Catalog: 5762 (Lot serial: >100 numbers contact mfg.); Model Catalog: 5761 (Lot serial: >100 numbers contact mfg.); Model Catalog: 813547 (Lot serial: >100 numbers contact mfg.); Model Catalog: 813546 (Lot serial: >100 numbers contact mfg.); Model Catalog: 813544 (Lot serial: >100 numbers contact mfg.); Model Catalog: 4950 (Lot serial: >1000 numbers contact mfg.); Model Catalog: 4948 (Lot serial: >1000 numbers contact mfg.); Model Catalog: 15949 (Lot serial: >10 numbers contact mfg.); Model Catalog: 813588 (Lot serial: >100 numbers contact mfg.); Model Catalog: 813586 (Lot serial: >100 numbers contact mfg.); Model Catalog: 813583 (Lot serial: >1
  • Description du dispositif
    Sarns Dual-Stage Malleable Venous Return Catheter
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.