Events

Recall of CELLEX PHOTOPHERSIS SYSTEM - PROCEDURAL KIT

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

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
    24584
  • Event Risk Class
    II
  • Event Initiated Date
    2010-04-05
  • 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
    Therakos recently became aware that some customers have experienced a higher rate of blood leaks than what is typical for this product. these leaks which occur between the centrifuge bowl and the drive tube may or may not be preceded by a system pressure alarm or a blood leak alarm and have been observed at various stages of treatment.

Device

CELLEX PHOTOPHERSIS SYSTEM - PROCEDURAL KIT
  • Model / Serial
    Model Catalog: CLXECP (Lot serial: X121)
  • Product Description
    THERAKOS CELLEX PROCEDURAL KITS
  • Manufacturer
    THERAKOS INC.

Manufacturer

THERAKOS INC.
  • Manufacturer Address
    WEST CHESTER
  • Manufacturer Parent Company (2017)
    Mallinckrodt Plc
  • Source
    HC