Recall of SARNS CONDUCER CARDIOPLEGIA SETS WITH MP-4 AND BRIDGE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by 3M CANADA COMPANY.

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
    73028
  • Event Risk Class
    II
  • Event Initiated Date
    1999-12-16
  • Event Country
  • 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
    Defective seals may compromise sterility. some seals were narrower than the intended seal width and one had seal voids.

Device

  • Model / Serial
    Model Catalog: 4459 (Lot serial: W503200 W503594 W503362); Model Catalog: 4459 (Lot serial: W502731 W502716)
  • Product Description
    CONDUCER CARDIOPLEGIA SET WITH MP-4
  • Manufacturer

Manufacturer

  • Manufacturer Address
    LONDON
  • Manufacturer Parent Company (2017)
  • Source
    HC