Events

Recall of Device Recall Therakos Cellex 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
    57518
  • Event Risk Class
    Class 2
  • Event Number
    Z-2839-2011
  • Event Initiated Date
    2010-12-02
  • Event Date Posted
    2011-07-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96448
  • 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
    Cellex procedural kits may have minor tears in their tyvek covers.
  • Action
    Therakos, Inc. sent an "Important Product Notification" dated December 2, 2010 to all affected customers. The letter included description of problem, affected lot and recommendations. Customers were asked to dispose any product with affected lot and to contact them for for replacement, and to complete and return the attached Fax reply form. For additional information contact Therakos Customer Technical Services at 877-865-6850.

Device

Device Recall Therakos Cellex Procedural Kits
  • Model / Serial
    Lot: Y302 Product code: CLXUSA
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide (USA) distribution including the state of MI, MO, WI, CA, OH, NH, MA, and OR.
  • Product Description
    Therakos Cellex Procedural Kits. || Designed to interface with the Cellex Photopheresis System to perform cell separation and photoactivation in a single, closed and sterile circuit.
  • 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