Events

Recall of PLASTIC NEEDLE WITH MANDRIN

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
    152416
  • Event Risk Class
    II
  • Event Initiated Date
    2011-07-29
  • 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
    Previous recall (53838) addressed needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal. recall 66002 supplements and modifies previous noticewhere users are instructed to stop using any plastic needles they may have in inventory with lot numbers c01 to d01 and those with lot numbers which start with h or i. this recall also requires users to return any plastic needles with lot numbers c01 to d01 and those lot numbers which start with h or i to varian brachiotherapy for replacement with plastic needles starting with lot j or higher.

Device

PLASTIC NEEDLE WITH MANDRIN
  • Model / Serial
    Model Catalog: GM11007570 (Lot serial: >10 lot numbers.); Model Catalog: GM11007560 (Lot serial: >10 lot numbers.); Model Catalog: GM11007560 (Lot serial: Contact manufacturers.); Model Catalog: GM11007570 (Lot serial: Contact manufacturers.); Model Catalog: GM11007580 (Lot serial: Contact manufacturers.); Model Catalog: GM11007580 (Lot serial: >10 lot numbers.)
  • Product Description
    PLASTIC NEEDLE WITH MANDRIN
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.