Events

Recall of INTEGRA LED HEADLIGHT BATTERY CHARGER

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

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
    112941
  • Event Risk Class
    II
  • Event Initiated Date
    2014-07-06
  • 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
    Integra lifesciences has identified through an investigation of complaints that some lot numbers of the integra led single bay battery charger (catalogue no. 90523) may prematurely fail and will not charge the integra led battery as intended. there have been no reports of an injury or other adverse patient consequences associated with the complaints. customers may have received an affected 90523 directly or had it provided with one of the following: led headlight systems (catalogue no. 90520us) or battery kits (catalogue no. 90530us).

Device

INTEGRA LED HEADLIGHT BATTERY CHARGER
  • Model / Serial
    Model Catalog: 95023 (Lot serial: > 10 numbers contact mfg.)
  • Product Description
    INTEGRA LED BATTERY CHARGER SINGLE BAY
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.