Events

Recall of EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COOK (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
    26760
  • Event Risk Class
    III
  • Event Initiated Date
    2014-02-24
  • 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
    Label placed on the handle of the device indicates it is 11 fr. in diameter when in fact it is 9 fr. all packaging and other labeling indicates the correct sizing information. one lot number is being recalled in canada.

Device

EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
  • Model / Serial
    Model Catalog: LR-EVN-9.0-RL (Lot serial: N116626)
  • Product Description
    COOK 9 FR. EVOLUTION RL DILATOR SHEATH SET
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.