Events

Recall of HEMOLINE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GAMBRO DASCO S.P.A..

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
    28559
  • Event Risk Class
    II
  • Event Initiated Date
    2008-05-14
  • 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
    Occlusion totale ou partielle potentielle du connecteur arteriel (rouge) et/ou veineux (bleu) pouvant engendrer un risque d'hemolyse du patient.

Device

HEMOLINE
  • Model / Serial
    Model Catalog: 6032205-105551 (Lot serial: 80A); Model Catalog: 6187017-105623 (Lot serial: 808 809 815 816); Model Catalog: 6185177-101590 (Lot serial: 80A); Model Catalog: 112516 (Lot serial: 80A); Model Catalog: 112515 (Lot serial: 80A); Model Catalog: 6032205-105551 (Lot serial: 816); Model Catalog: 6185391-105687 (Lot serial: 816); Model Catalog: 6185177-101590 (Lot serial: 816); Model Catalog: 112516 (Lot serial: 816); Model Catalog: 112515 (Lot serial: 816); Model Catalog: 6032205-105551 (Lot serial: 813 814); Model Catalog: 6185391-105687 (Lot serial: 813 814); Model Catalog: 6185177-101590 (Lot serial: 813 814); Model Catalog: 112516 (Lot serial: 813 814); Model Catalog: 112515 (Lot serial: 813 814); Model Catalog: 6032205-105551 (Lot serial: 809 812); Model Catalog: 6185391-105687 (Lot serial: 809 812); Model Catalog: 6185177-101590 (Lot serial: 809 812); Model Catalog: 112516 (Lot serial: 809 812); Model Catalog: 112515 (Lot serial: 809 812); Model Catalog: 6032205-105551 (Lot serial: 80 809 811);
  • Product Description
    Hemoline
  • Manufacturer
    GAMBRO DASCO S.P.A.

Manufacturer

GAMBRO DASCO S.P.A.