Events

Recall of LEVEL 1 NORMOTHERMIC I.V. FLUID ADMINISTRATION 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
    84980
  • Event Risk Class
    II
  • Event Initiated Date
    2011-06-20
  • 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 is recalling all level 1 normothermic iv fluid administration sets equipped with the f-50 gas vent filter assembly (gvfa) from the market and temporarily suspending all sales of these products because of complaints of kinking of the tubing and leaking of the f-50 gvfa. in some cases kinking in the tubing or leaking of the f-50 gvfa can cause a decrease in fluid flow rate.

Device

LEVEL 1 NORMOTHERMIC I.V. FLUID ADMINISTRATION SETS
  • Model / Serial
    Model Catalog: DI-350 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: DI-65HL (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: DI-75 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: DI-150 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: F-50 (Lot serial: 1851840); Model Catalog: F-50 (Lot serial: 1904351)
  • Product Description
    LEVEL 1 NORMOTHERMIC IV FLUID 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