Events

Recall of NUTRILINE CATHETER WITH STYLET AND MICROFLASH

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ADVANCED SURGI-PHARM/BATRIK MEDICAL MFG./IMPERIAL SURGICAL LTD..

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
    25935
  • Event Risk Class
    III
  • Event Initiated Date
    2017-07-12
  • 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
    Two vygon nutriline kits are being recalled because it was found that they were packaged with an incorrect version of the microflash introducer. the version packaged in the affected product is a ce-marked version that is not yet cleared in the us or licensed in canada. the change of introducer insider the nutriline kits was made in error as the un-licensed introducer was not approved to be in the nutriline kits.

Device

NUTRILINE CATHETER WITH STYLET AND MICROFLASH

Manufacturer

ADVANCED SURGI-PHARM/BATRIK MEDICAL MFG./IMPERIAL SURGICAL LTD.
  • Manufacturer Address
    DORVAL
  • Source
    HC