Events

Recall of STATLOCK CV PLUS STABILIZATION DEVICE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BARD CANADA 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
    111701
  • Event Risk Class
    II
  • Event Initiated Date
    2016-12-16
  • 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
    Bard access systems has become aware that a specific lot of statlock catheter stabilization device single unit pouches was released without unique product identifiers including product description package contents product code lot number and expiration date. the product was distributed in cases of 50 unit pouches. the case label is correct and complete. product return is not required.

Device

STATLOCK CV PLUS STABILIZATION DEVICE
  • Model / Serial
    Model Catalog: CV0220 (Lot serial: JUAPF369)
  • Product Description
    STATLOCK CV PLUS STABILIZATION DEVICE
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.