Events

Recall of HYPERGEL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MOLNLYCKE HEALTH CARE.

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
    36707
  • Event Risk Class
    III
  • Event Initiated Date
    2009-09-22
  • 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
    Hypergel 5 gram product code 360500 lot numbers 08d22-156-32913 and 08d22-157 have been distributed with a lot number deficiency wherein the lot number listed on the packaging does not match the lot number on the individual piece.

Device

HYPERGEL
  • Model / Serial
    Model Catalog: 360500 (Lot serial: 08D22-157); Model Catalog: 360500 (Lot serial: 08D22-156-32913)
  • Product Description
    HYPERGEL 5 GRAM
  • Manufacturer
    MOLNLYCKE HEALTH CARE

Manufacturer

MOLNLYCKE HEALTH CARE
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Investor AB
  • Source
    HC