Events

Recall of Device Recall Cellex Photopheresis System

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
    73012
  • Event Risk Class
    Class 2
  • Event Number
    Z-1322-2016
  • Event Initiated Date
    2015-12-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142725
  • 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
    System, photopheresis, extracorporeal - Product Code LNR
  • Reason
    The mallinckrodt (therakos) post-market monitoring process detected an increased trend in tubing leaks within the pump tubing organizer, associated with a portion of kits from lot d 342.
  • Action
    Therakos sent an Urgent Medical Device Recall letter dated December 23, 2015, to all affected customers by UPS Overnight Mail. The letter identified the product, the problem, and the action to be taken by the customer. The consignees were instructed to immediately identify, discontinue use and return affected product. Customers with questions were instructed to call Therakos Customer Service at 1-855-422-9115, option 4. For questions regarding this recall call 908-238-6813.

Device

Device Recall Cellex Photopheresis System
  • Model / Serial
    Mfr lot #D342
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to AL, AZ, CA, CO, DC, FL, ID, IL, IN, MA, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, UT, VT, AND WI.
  • Product Description
    The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. || Manufacturing lot D342 || UDI: 20705030200003 || The system designed to separate the patient's blood into various fractions and collect the white blood cell (WBC) fraction. The WBC fraction is treated with a photoactive drug UVADEX¿ (methoxsalen) Sterile Solution. The UVADEX is photo-activated by UVA light and results in the WBCs undergoing apoptosis
  • Manufacturer
    Therakos Inc

Manufacturer

Therakos Inc
  • Manufacturer Address
    Therakos Inc, 10 N High St, West Chester PA 19380-3003
  • Manufacturer Parent Company (2017)
    Mallinckrodt Plc
  • Source
    USFDA