Events

Recall of TRANSLUMINAL BILIARY BIOPSY FORCEPS SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COOK (CANADA) INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    24203
  • Event Risk Class
    I
  • Event Initiated Date
    2016-04-18
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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
  • Product Classification
    Gastroenterology-Urology Devices
  • Product Description
    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.