Events

Recall of UVAR XTS PHOTOPHERESIS SYSTEM - PROCEDURAL KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ORTHO-CLINICAL DIAGNOSTICS.

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
    66072
  • Event Risk Class
    II
  • Event Initiated Date
    2011-04-05
  • 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 has received an increased rate of complaints related to leaks at tubing connections for certain lots of therakos uvar xts procedural kits. internal investigation has determined that a raw material used in the manufacture of the kit is causing leaks to occur in certain lots.

Device

UVAR XTS PHOTOPHERESIS SYSTEM - PROCEDURAL KIT
  • Model / Serial
    Model Catalog: XT001 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: XT125 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    THERAKOS UVAR XTS PROCEDURAL KITS
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS