Events

Recall of COMBINED SPINAL/EPIDURAL NEEDLE SET WITH LOCK

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
    47835
  • Event Risk Class
    II
  • Event Initiated Date
    2005-12-28
  • 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
    Possibility of device being not sterile.

Device

COMBINED SPINAL/EPIDURAL NEEDLE SET WITH LOCK
  • Model / Serial
    Model Catalog: 100/396/716 (Lot serial: 102139 to 499969); Model Catalog: 100/396/318 (Lot serial: 102139 to 499969); Model Catalog: 100/396/916 (Lot serial: 102136 to 493491); Model Catalog: 100/396/718 (Lot serial: 102136 to 493491); Model Catalog: 100/396/716 (Lot serial: 102136 to 493491); Model Catalog: 100/396/318 (Lot serial: 102136 to 493491); Model Catalog: 100/396/718 (Lot serial: 102139 to 499969); Model Catalog: 100/396/916 (Lot serial: 102139 to 499969); Model Catalog: 100/396/318 (Lot serial: 101064 to 499973); Model Catalog: 100/396/716 (Lot serial: 101064 to 499973); Model Catalog: 100/396/916 (Lot serial: 101064 to 499973); Model Catalog: 100/396/718 (Lot serial: 101064 to 499973)
  • Product Description
    portex epidural and spinal needle set
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

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