Events

Recall of SITE ADHESIVE SAMPLE KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDTRONIC OF CANADA LTD..

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
    84312
  • Event Risk Class
    II
  • Event Initiated Date
    2011-04-08
  • 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
    Iv prep antiseptic wipes are packaged inside the "site adhesive sample kit". these wipes are part of a recall by the distributor "smith & nephew" due to a potential bacterial contamination found at the manufacturer "the triad group". (lot# for "iv prep antiseptic wipes": 9k141 9k142 9k143 0f131 0f140 0g249 0g255 0g256 0g259 0k139 0k140 0k193 0m180 0m216 1a212 1a213).

Device

SITE ADHESIVE SAMPLE KIT
  • Model / Serial
    Model Catalog: MMT-643 (Lot serial: )
  • Product Description
    Sample Tape Kit -IV Prep Pad
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Manufacturer Address
    BRAMPTON
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC