Events

Recall of PICC CONVENIENCE KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NAVILYST MEDICAL 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
    53610
  • Event Risk Class
    III
  • Event Initiated Date
    2017-10-16
  • 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
    Angiodynamics inc. (dba navilyst medical. inc.) the manufacturer of the xcela picc with pasv technology convenience kit for centenary hospital (4f single lumen) is conducting a medical device recall to the end user level. angiodynamics has determined that the affected product contains an inaccurate product description on the labelling the product is labelled as 5f - 55cm and the product is actually 4f - 55cm. angiodynamics began distributing product affected by this recall on july 14 2017.

Device

PICC CONVENIENCE KIT
  • Model / Serial
    Model Catalog: H96560M7XXXXXX (Lot serial: 5228251); Model Catalog: H96560M7XXXXXX (Lot serial: 5210162)
  • Product Description
    Xcela PICC with PASV Technology Convenience Kit
  • Manufacturer
    NAVILYST MEDICAL INC.

Manufacturer

NAVILYST MEDICAL INC.
  • Manufacturer Address
    MARLBOROUGH
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    HC