Recall of BD PHOENIX SYSTEM - NMIC 1

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECTON DICKINSON 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
    59051
  • Event Risk Class
    II
  • Event Initiated Date
    2018-01-09
  • Event Country
  • 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
    There is an increased rate of very major errors (vme) for colistin with colistin resistant strains of the enterobacteriaceae (17.5%). this percentage is derived from a recently-concluded external study and likely involve emerging hetero-resistant strains.

Device

  • Model / Serial
    Model Catalog: 448063 (Lot serial: 7276978); Model Catalog: 448063 (Lot serial: 7095829); Model Catalog: 448764 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 448788 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    PANEL PHOENIX NMIC/ID 66;PANEL PHOENIX NMIC 203 AND PANEL PHOENIX NMIC 404
  • Manufacturer

Manufacturer