Events

Recall of Device Recall Therakos 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
    55300
  • Event Risk Class
    Class 2
  • Event Number
    Z-1654-2010
  • Event Initiated Date
    2010-03-29
  • Event Date Posted
    2010-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90508
  • 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
    photopheresis kit - Product Code LNR
  • Reason
    Higher than normal blood leaks on therakos cellex procedural kits that are intended for use with the therakos cellex photopheresis system.
  • Action
    On March 29, 2010, Therakos Photopheresis sent Important Product Correction Notification letters by FedEx to all direct end use and distributor customers who received lot X120 in addition to phone contact. On March 31, 2010 those who received lot X123 were sent letters by Fed Ex as well as phone contact.. The one Canadian customer was notified by phone on March 31, 2010 followed by a Fed Ex letter. On April 12, consignees who were shipped Lot X119 were contacted by phone, followed by a hard copy letter. On May 7, 2010 all direct end use and distributor consignees were notified of the additional lot being added to the recall. Questions may be directed to Therakos Customer Technical Services at 1-877-865-6850.

Device

Device Recall Therakos CellEx Photopheresis System
  • Model / Serial
    CLXUSA (US): Lot X120, Exp 12/10; X123, Exp 1/2011; Lot Y106, Exp 2/1/11. CLSECP (For European Union), Lot X119, Exp 12/2014; Lot X123; Exp 1/2015
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution, and Canada and Germany
  • Product Description
    Therakos CellEx Photopheresis System; || Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;
  • 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