Events

Recall of HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE

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
    125032
  • Event Risk Class
    II
  • Event Initiated Date
    2013-07-10
  • 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 has become aware of an issue with visible orange/brown particulate on some of hte needles of the 29g hypodermic needle-pro fixed needle insulin syringes. after a comprehensive investigation the particulate was found to consist of inorganic materials. while it is highly unlikely sensitive persons could experience a site reaction to the materials including infection or allergic reaction. smiths medical has received no reports of infection allergic reaction or injury related to this issue.

Device

HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE
  • Model / Serial
    Model Catalog: 4429-3 (Lot serial: 2336493); Model Catalog: 4429-5 (Lot serial: 2353094); Model Catalog: 4429-5 (Lot serial: 2357318); Model Catalog: 4429-3 (Lot serial: 2357318); Model Catalog: 4429-5 (Lot serial: 2336493); Model Catalog: 4429-3 (Lot serial: 2348708); Model Catalog: 4429-5 (Lot serial: 2348708); Model Catalog: 4429-3 (Lot serial: 2353094)
  • Product Description
    Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29g
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

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