Events

Recall of INFINITI PLUS DISPOSABLE NEEDLE GUIDE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CIVCO MEDICAL INSTRUMENTS CO. INC. DBA CIVCO.

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
    90154
  • Event Risk Class
    II
  • Event Initiated Date
    2018-02-16
  • 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
    Civco has recently discovered a quality issue with infiniti bracket. the affected brackets were included in the kits identified and manufactured between 11/2009 through 12/2017. description of problem: if the length of the mount may be longer than specified it can allow the needle guide insert to puncture the cover which is applied between the mount and needle guide assembly. this does not prevent the assembly from functioning as intended to keep the biopsy needle in the ultrasound scanning plane.

Device

INFINITI PLUS DISPOSABLE NEEDLE GUIDE
  • Model / Serial
    Model Catalog: 698-009 (Lot serial: M419650); Model Catalog: 698-009 (Lot serial: M427370); Model Catalog: 698-009 (Lot serial: M388690); Model Catalog: 698-009 (Lot serial: M220960)
  • Product Description
    INFINITI BRACKET (SOLD AS PART OF CIVCO BRAND BIOPSY STARTER KITS AND BIOPSY BRACKET)
  • Manufacturer
    CIVCO MEDICAL INSTRUMENTS CO. INC. DBA CIVCO

Manufacturer

CIVCO MEDICAL INSTRUMENTS CO. INC. DBA CIVCO