Events

Recall of CADD ADMINISTRATION SET

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
    149856
  • Event Risk Class
    II
  • Event Initiated Date
    2018-03-05
  • 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
    A detailed investigation points to a unique use case involving a single canadian customer using non-approved smiths medical pouches with the cadd? blue-striped administration set. use of non-approved accessories as indicated in labeling may adversely affect pump operation. smiths medical has decided to proceed with sending communication to notify all canadian customers who have purchased the cadd blue-striped administration set. the content of the fsn provides more information to the customer / user when using the administration set. fsn emphasizes the correct use of the product and how to avoid strain relief which in turn prevents leakage.

Device

CADD ADMINISTRATION SET
  • Model / Serial
    Model Catalog: 21-7036-01 (Lot serial: >1000 numbers contact mfg)
  • Product Description
    CADD Blue-Striped Administration 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