Events

Rappel de TRANSLUMINAL BILIARY BIOPSY FORCEPS SET

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par COOK (CANADA) 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
    24203
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2016-04-18
  • 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
    Cook medical has identified an increase in reports of polymer degradation of the catheter tip resulting in tip fracture and/or separation. their preliminary investigation into this matter has identified that environmental conditions such as storage temperature humidity and the use of vaporized hydrogen peroxide (vhp) for whole-room decontamination within healthcare facilities may be contributing to the occurrence. there may be other undetermined contributors to this issue. investigation is ongoing. potential adverse events that may occur as a result of catheter polymer degradation could include loss of device function separation of a device segment leading to medical intervention or complications resulting from a separated segment. such complications include device fragments in the vascular system genitourinary system or other soft tissues. fragments within the vascular system could result in embolization to the heart or lungs or occluding blood flow to end organs.

Device

TRANSLUMINAL BILIARY BIOPSY FORCEPS SET
  • Modèle / numéro de série
    Model Catalog: BBFS-100 (Lot serial: ALL); Model Catalog: J-RTAS-100 (Lot serial: ALL); Model Catalog: NSSW-4.0-18-NPAS-100-HC-SST (Lot serial: ALL); Model Catalog: NPAS-120-HC-NT-U-SST (Lot serial: ALL); Model Catalog: NPAS-108-HC-NT-U-SST (Lot serial: ALL); Model Catalog: NPAS-105-HC-NT-U-SST (Lot serial: ALL); Model Catalog: NPAS-104-HC-U-SST (Lot serial: ALL); Model Catalog: NPAS-104-HC-NT-U-SST (Lot serial: ALL); Model Catalog: NPAS-104-HC-NT-JWG-U-SST (Lot serial: ALL); Model Catalog: NPAS-101-HC-U-SST (Lot serial: ALL); Model Catalog: NPAS-101-HC-NT-U-SST (Lot serial: ALL); Model Catalog: NPAS-100-HC-U-SST (Lot serial: ALL); Model Catalog: NPAS-100-HC-NT-U-SST (Lot serial: ALL); Model Catalog: HNR5.0-XXX (Lot serial: ALL); Model Catalog: SCBR6.5-XXX (Lot serial: ALL); Model Catalog: SCBR5.5-XXX (Lot serial: ALL); Model Catalog: SCBR5.0-XXX (Lot serial: ALL); Model Catalog: HTPS-XXX (Lot serial: ALL); Model Catalog: NR5.0-35-90-P-10S-VCF-CAVA (Lot serial: ALL); Model Catalog: NR5.0-35-90-P-10S-PIG-CAVA
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Description du dispositif
    TRANSLUMINAL BILIARY BIOPSY FORCEPS SET;FLUOROSET RADIOGRAPHIC TUBAL ASSESSMENT SET;APRIMA ACCESS NONVASCULAR INTRODUCER SET;BEACON TIP ROYAL FLUSH PLUS HIGH-FLOW CATHETER;SHUTTLE SELECT SLIP-CATH AND SLIP-CATH BEACON TIP CATHETER;HASKAL TRANSJUGULAR INTR
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.