Events

Recall of CERVIX-APPLICATOR SET

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
    79255
  • Event Risk Class
    II
  • Event Initiated Date
    2012-09-28
  • 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
    Due to a manufacturing error in lot l33 the gripping jaws are not sufficiently flexible to disconnect easily from the intended cervical sleeves. gm11000960 cervical sleeves 40mm with clamp for guide tube gm11001260 cervical sleeves 60mm with clamp for guide tube gm11001140 cervical sleeves 80mm with clamp for guide tube. if an affected guide tube is connected to an implanted cervical sleeve disconnection will be difficult. if removal is attempted with sufficient force to tear the anchoring sutures it is possible that the patient will be injured. the issue is limitated to devices with the manufacturing lot 33.

Device

CERVIX-APPLICATOR SET
  • Model / Serial
    Model Catalog: GM11004540 (Lot serial: H600272)
  • Product Description
    Cervix- Applicator Set
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.