Events

Recall of NUPORT PEG GASTROSTOMY TUBE KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NOVARTIS NUTRITION CORPORATION.

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
    26371
  • Event Risk Class
    II
  • Event Initiated Date
    2000-07-25
  • 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
    Separation between the silicone tube and the acrylic dilator during placement which could result in surgical intervention.

Device

NUPORT PEG GASTROSTOMY TUBE KIT
  • Model / Serial
    Model Catalog: 87500 (Lot serial: LOT #S: 0910NX 1669NX); Model Catalog: 87500 (Lot serial: 2679NX 3099NX 3519NX.); Model Catalog: 84000 (Lot serial: LOT #S: 0680KX 2679KX)
  • Product Description
    22 FR NUPORT PEG
  • Manufacturer
    NOVARTIS NUTRITION CORPORATION

Manufacturer

NOVARTIS NUTRITION CORPORATION
  • Manufacturer Address
    MISSISSAUGA
  • Source
    HC