Events

Recall of CCS CONTROL SYRINGE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INTER V MEDICAL 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
    18341
  • Event Risk Class
    II
  • Event Initiated Date
    2004-09-28
  • 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
    Potential for air to be drawn into the syringe due to a dimensional mismatch (mold mis-alignment) at set-up.

Device

CCS CONTROL SYRINGE
  • Model / Serial
    Model Catalog: CCS880 (Lot serial: A337519 A333586 A337519); Model Catalog: CCS880 (Lot serial: A337519 A341381)
  • Product Description
    INJECT8 CORONARY CONTROL SYRINGE
  • Manufacturer
    INTER V MEDICAL INC.

Manufacturer

INTER V MEDICAL INC.
  • Manufacturer Address
    MONTREAL
  • Source
    HC