Events

Recall of DIDECO PERF TUBING SYS ARTER FLTR HEMOCONCNTRATOR CARDIO RESERV W/WO PHISIO

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
    18888
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-11
  • 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
    Livanova is recalling some custom perfusion tubing systems (pts) packs containing male luer connectors that may be partially occluded following complaints of difficulties draining fluids on lines included in the pts. the reported connector occlusion was generated during molding of one specific lot of luer.

Device

DIDECO PERF TUBING SYS ARTER FLTR HEMOCONCNTRATOR CARDIO RESERV W/WO PHISIO
  • Model / Serial
    Model Catalog: 086004 (Lot serial: 1706190111); Model Catalog: AB1425 (Lot serial: 1706190110)
  • Product Description
    PERFUSION TUBING SYSTEMS PACK (086004);PERFUSION TUBING SYSTEMS PACK (AB1425)
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

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