Events

Recall of P2 MAGNUM 360 TRIAL KIT MONOPHASE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HERAEUS KULZER 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
    20033
  • Event Risk Class
    III
  • Event Initiated Date
    2004-08-13
  • 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
    Quality of knife holder in foil bag not acceptable.

Device

P2 MAGNUM 360 TRIAL KIT MONOPHASE
  • Model / Serial
    Model Catalog: (Lot serial: LOT 195417); Model Catalog: (Lot serial: LOT 195412); Model Catalog: (Lot serial: 195411R); Model Catalog: (Lot serial: 195420); Model Catalog: (Lot serial: 190395); Model Catalog: (Lot serial: LOT 190411); Model Catalog: (Lot serial: )
  • Product Description
    P2 MAGNUM 360 TRIAL KIT MONOPHASE
  • Manufacturer
    HERAEUS KULZER INC.

Manufacturer

HERAEUS KULZER INC.
  • Manufacturer Address
    MISSISSAUGA
  • Source
    HC