Events

Recall of URETHRAL PROCEDURAL TRAY WITH SYRINGE

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

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
    65613
  • Event Risk Class
    II
  • Event Initiated Date
    2011-03-04
  • 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 affected trays contain alcohol prep pad that are included in the scope of a field corrective initiated by triad group due to concerns about potential bacterial contamination of the prep pads. if contaminated alcohol prep pads are used there is a potential for infection to occur.

Device

URETHRAL PROCEDURAL TRAY WITH SYRINGE
  • Model / Serial
    Model Catalog: 68895 (Lot serial: MORE THAN 10 LOT NUMBERS); Model Catalog: 67890 (Lot serial: MORE THAN 10 LOT NUMBERS)
  • Product Description
    Urethral Procedutal Tray with Syringe
  • Manufacturer
    TELEFLEX MEDICAL

Manufacturer

TELEFLEX MEDICAL