Events

Recall of Device Recall Therakos UVAR XTS Procedural Kits

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    57912
  • Event Risk Class
    Class 2
  • Event Number
    Z-2067-2011
  • Event Initiated Date
    2011-02-01
  • Event Date Posted
    2011-04-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97743
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Extracorporeal Photopheresis System - Product Code LNR
  • Reason
    Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of therakos uvar xts procedural kits (product code xt 125).
  • Action
    Therakos notified all direct Therakos US and ex-US End Users and Distributor consignees via Federal Express courier with an Urgent Product Correction Notification, dated 2/1/2011. The letter identified the reason for recall along with the affected product. Customers were to immediately discontinue using and discard the identified affected lots of the product. Customers were to use alternative lots. In order to receive credit for the discarded product, customers were to complete the attached confirmation of receipt and destruction. If there were any questions, a question and answer section was provided but additional questions could be directed towards Therakos Customer Service Center at 1-800-828-6316, Option 2,1.

Device

Device Recall Therakos UVAR XTS Procedural Kits
  • Model / Serial
    Lots Y703 through Y707 and Y709 though Y726  Lot Number - Expiration Date Y703, 1/1/2015 Y704, 2/1/2015 Y705, 2/1/2015 Y706, 2/1/2015 Y707, 2/1/2015 Y709, 2/1/2015 Y710, 3/1/2015 Y711, 3/1/2015 Y712, 3/1/2015 Y713, 3/1/2015 Y714, 3/1/2015 Y715, 3/1/2015 Y716, 3/1/2015 Y717, 4/1/2015 Y718, 4/1/2015 Y719, 4/1/2015 Y720, 4/1/2015 Y721, 4/1/2015 Y722, 4/1/2015 Y723, 4/1/2015 Y724, 4/1/2015 Y725, 5/1/2015; and Y726, 5/1/2015.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Therakos UVAR XTS Procedural Kits || Is indicated for use in the ultraviolet-A (UVA) irradiation.
  • Manufacturer
    Therakos Inc

Manufacturer

Therakos Inc
  • Manufacturer Address
    Therakos Inc, 1001 Us Highway 202, Raritan NJ 08869
  • Manufacturer Parent Company (2017)
    Mallinckrodt Plc
  • Source
    USFDA