Events

Recall of PORT-A-CATH II DUAL LUMEN SYSTEM

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
    24072
  • Event Risk Class
    II
  • Event Initiated Date
    2013-09-06
  • 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
    Since august 2009 smiths medical has received a total of 3 complaints regarding the introducer sheath and the introducer opening being too small for the width of the catheter experienced with port-a-cath and port-a-cath ii implantable venous and arterial access systems and introducer sets. there have been no reports of patient injury or death associated with this issue. investigation of this issue has identified the root cause to be related to the incorrect size introducer being used in several lots of finished goods. an in-depth investigation concluded that the incorrect introducer size was limited to 1 component part (from st. jude medical) which were put into production of 36 smiths medical finished goods lot numbers.

Device

PORT-A-CATH II DUAL LUMEN SYSTEM
  • Model / Serial
    Model Catalog: 21-8052-24 (Lot serial: 1971572)
  • Product Description
    Port-A-Cath II Implantable Venous Access System
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

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