Events

Recall of ELIMINATOR PET BALLOON DILATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CONMED ENDOSCOPIC TECHNOLOGIES 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
    53612
  • Event Risk Class
    II
  • Event Initiated Date
    2007-04-20
  • 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
    Packaging mislabeling issues. potential discrepancies on the lot number the size indication the tag on the product and the device description on the box product and internal packaging.

Device

ELIMINATOR PET BALLOON DILATOR
  • Model / Serial
    Model Catalog: 000859 (Lot serial: FROM 0605031); Model Catalog: 000858 (Lot serial: FROM 0605031); Model Catalog: 000857 (Lot serial: FROM 0605031); Model Catalog: 000849 (Lot serial: FROM 0605031); Model Catalog: 000848 (Lot serial: FROM 0605031); Model Catalog: 000847 (Lot serial: FROM 0605031); Model Catalog: 000846 (Lot serial: FROM 0605031); Model Catalog: 000845 (Lot serial: FROM 0605031); Model Catalog: 000844 (Lot serial: FROM 0605031); Model Catalog: 000736 (Lot serial: FROM 0605031); Model Catalog: 000735 (Lot serial: FROM 0605031); Model Catalog: 000847 (Lot serial: TO 0612141); Model Catalog: 000380 (Lot serial: FROM 0605031); Model Catalog: 000379 (Lot serial: FROM 0605031); Model Catalog: 000345 (Lot serial: FROM 0605031); Model Catalog: 000344 (Lot serial: FROM 0605031); Model Catalog: 000343 (Lot serial: FROM 0605031); Model Catalog: 000342 (Lot serial: FROM 0605031); Model Catalog: 000341 (Lot serial: FROM 0605031); Model Catalog: 000861 (Lot serial: FROM 0605031); Model Catalog: 000867 (Lo
  • Product Description
    PET ELIMINATOR BALLOON DILATOR
  • Manufacturer
    CONMED ENDOSCOPIC TECHNOLOGIES INC.

Manufacturer

CONMED ENDOSCOPIC TECHNOLOGIES INC.
  • Manufacturer Address
    CHELMSFORD
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    HC