Events

Recall of DISPOSABLE LIGHT HANDLE COVER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MICROTEK MEDICAL 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
    128287
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-18
  • 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
    The reason for the recall is that the sterile packaging may contain gaps in the seal of the pouch. if gaps are present the packaging integrity is compromised and there exists a chance that a non-sterile surgical light handle cover may be used during a surgical procedure.

Device

DISPOSABLE LIGHT HANDLE COVER
  • Model / Serial
    Model Catalog: B1-715-65 (Lot serial: > 10 numbers contact mfg.)
  • Product Description
    DISPOSABLE LIGHT HANDLE COVER
  • Manufacturer
    MICROTEK MEDICAL INC.

Manufacturer

MICROTEK MEDICAL INC.
  • Manufacturer Address
    COLUMBUS
  • Manufacturer Parent Company (2017)
    Ecolab Inc
  • Source
    HC