Events

Recall of ONE PIECE TUOHY-BORST INTRODUCER TRAY

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

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
    51869
  • Event Risk Class
    I
  • Event Initiated Date
    2000-04-07
  • 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
    Lack of sterility assurance in clinipad swabs wipes and towelettes. product code: 497454 note: device id#157716 also has this product code.

Device

ONE PIECE TUOHY-BORST INTRODUCER TRAY
  • Model / Serial
    Model Catalog: (Lot serial: ALL LOTS OF 497454); Model Catalog: (Lot serial: ALL LOTS OF 497661 & 497688); Model Catalog: (Lot serial: ALL LOTS OF 497425); Model Catalog: (Lot serial: ALL LOTS OF 398813A 400763A); Model Catalog: (Lot serial: 400763B 400989 & 401351); Model Catalog: (Lot serial: ALL LOTS OF 497259)
  • Product Description
    ONE PIECE TUOHY-BORST INTRODUCER TRAY
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

LIVANOVA CANADA CORP.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    HC