Events

Recall of HIPRO BIOPSY DRESSING TRAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ASSOCIATED HEALTH 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
    106560
  • Event Risk Class
    II
  • Event Initiated Date
    2013-10-03
  • 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
    A limited number of hipro minor dressing/wound cleansing trays have been distributed that contained a folded towel that did not have an internal plastic barrier. if this towel was used to create a sterile field/barrier it may allow a pass through of fluid thus compromising the sterile field.

Device

HIPRO BIOPSY DRESSING TRAY
  • Model / Serial
    Model Catalog: TRDR107 (Lot serial: SH091123A)
  • Product Description
    HiPro Minor Dressing Trays
  • Manufacturer
    ASSOCIATED HEALTH SYSTEMS INC.

Manufacturer

ASSOCIATED HEALTH SYSTEMS INC.