Events

Recall of COOL LINE CENTRAL VENOUS HEAT EXCHANGE CATHETER KITS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ALSIUS CORPORATION.

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
    117700
  • Event Risk Class
    II
  • Event Initiated Date
    2007-01-01
  • 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
    Testing by alsius has identified that 6-10% of catheters from the affected lot may exhibit a significant reduction in heat exchange capacity.

Device

COOL LINE CENTRAL VENOUS HEAT EXCHANGE CATHETER KITS
  • Model / Serial
    Model Catalog: CL-2295AE (Lot serial: 16243)
  • Product Description
    Cool Line Catheter Model CL-2295AE
  • Manufacturer
    ALSIUS CORPORATION

Manufacturer

ALSIUS CORPORATION
  • Manufacturer Address
    IRVINE
  • Source
    HC