Events

Recall of RING AND TANDEM COMBO KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by VARIAN 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
    82186
  • Event Risk Class
    II
  • Event Initiated Date
    2012-10-01
  • 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
    An anomaly has been identified with the al07289000 rectal retractor stainless steel. the rectal retractors have shown evidence that contaminates or fluids may enter into the center of the rectal retractor paddle through the cross pins or bottom rod areas. the rectal retractor instruments have been identified to potentially have contaminating materials present after clinical use that cannot be removed by the instructed cleaning disinfecting and sterilization method. at this time it appears that the design of the paddle component is allowing for ingress and retention of bodily fluids or cleaning reagents during their clinical use and during their reprocessing for re-use. this issue is an internal finding - therefore no misadministration or serious deterioration in the state of health was reported. there have been no reports of this issue that have occurred in canada or within the eea member states.

Device

RING AND TANDEM COMBO KIT
  • Model / Serial
    Model Catalog: AL13016002 (Lot serial: H600346); Model Catalog: AL13015000 (Lot serial: H600346); Model Catalog: AL13016000 (Lot serial: H600346); Model Catalog: AL13016001 (Lot serial: H600346)
  • Product Description
    Ring and Tandem Combo Kit
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.