Events

Recall of SURGICAL TRAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MERIT MEDICAL SYSTEMS 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
    129857
  • Event Risk Class
    III
  • Event Initiated Date
    2017-02-21
  • 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
    Merit medical systems inc. is forwarding an urgent product advisory notice for custom procedure trays containing the affected bd eclipse needle. bd has received reports of safety cover disengagement and needlestick injury (nsi) for the bd eclipse needle. based on the customer reports in some cases when the safety cover is pushed over the needle it disengages resulting in an exposed needle which can increase the risk of nsi.

Device

SURGICAL TRAY
  • Model / Serial
    Model Catalog: K12T-08409 (Lot serial: T915590)
  • Product Description
    SURGICAL TRAY
  • Manufacturer
    MERIT MEDICAL SYSTEMS INC.

Manufacturer

MERIT MEDICAL SYSTEMS INC.