Events

Recall of HIGH FLOW FLUID WARMING DISPOSABLE SETS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SMITHS MEDICAL CANADA LTD. (SIMS).

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
    47070
  • Event Risk Class
    II
  • Event Initiated Date
    2008-11-12
  • 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
    Smiths medical canada inadvertently shipped a small quantity of product that was subject to a recall (#36749).These units were recalled because the heat exchangers in some sets had a leakage of the inner lumen.

Device

HIGH FLOW FLUID WARMING DISPOSABLE SETS
  • Model / Serial
    Model Catalog: DI-100 (Lot serial: 1057962); Model Catalog: DI-50 (Lot serial: 1057962); Model Catalog: DI-50 (Lot serial: 1086185); Model Catalog: DI-100 (Lot serial: 1086185)
  • Product Description
    DISPOSABLE NORMOTHERMIC IV ADMIN. SETS
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    HC