Events

Recall of AMC/4 ARTERIAL NEEDLE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIVANOVA CANADA CORP..

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
    53874
  • Event Risk Class
    II
  • Event Initiated Date
    2017-05-25
  • 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
    Argon medical is conducting a recall to notify customers of a potential packaging defect. the product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch. the risk is limited to any products packaged on december 15 2016. the expected rate of defect is mall and the type of defect is visible with the naked eye. the product literature warns the user to not use this product if the packaging is opened or damaged.

Device

AMC/4 ARTERIAL NEEDLE
  • Model / Serial
    Model Catalog: 195352 (Lot serial: 11160990); Model Catalog: 195322 (Lot serial: 11160990); Model Catalog: 195355 (Lot serial: 11160990); Model Catalog: 195352 (Lot serial: 11161729); Model Catalog: 195355 (Lot serial: 11160912); Model Catalog: 195355 (Lot serial: 11161729); Model Catalog: 195352 (Lot serial: 11160912); Model Catalog: 195322 (Lot serial: 11160912); Model Catalog: 195322 (Lot serial: 11161729)
  • Product Description
    ARTERIAL NEEDLES
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

LIVANOVA CANADA CORP.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    HC