Events

Recall of IRRIGATION DISPOSIBLE 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
    68256
  • Event Risk Class
    II
  • Event Initiated Date
    2007-08-01
  • 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
    Some heat exchangers in these irrigation sets may have a leakage of the inner lumen which may allow the heating fluid to enter the patient fluid path or vice versa which can cause contamination of the blood.

Device

IRRIGATION DISPOSIBLE SETS
  • Model / Serial
    Model Catalog: IR-600 (Lot serial: ); Model Catalog: D-100 (Lot serial: ); Model Catalog: D-300 (Lot serial: ); Model Catalog: D-50 (Lot serial: ); Model Catalog: D-60HL (Lot serial: ); Model Catalog: DI-100 (Lot serial: ); Model Catalog: DI-50 (Lot serial: ); Model Catalog: DI-60HL (Lot serial: ); Model Catalog: IR-40 (Lot serial: ); Model Catalog: IR-500 (Lot serial: )
  • Product Description
    DISPOSABLE IRRIGATING SETS (IR SERIES)
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

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