Events

Recall of Device Recall Therakos Photopheresis Procedural Kit for use with the UVAR XTS

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
    35894
  • Event Risk Class
    Class 2
  • Event Number
    Z-1504-06
  • Event Initiated Date
    2006-07-18
  • Event Date Posted
    2006-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47108
  • 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
    Blood collection kit - Product Code LNR
  • Reason
    Centrifuge bowl may leak.
  • Action
    The recalling firm sent a recall letter dated 7/18/06 to their customers informing them of the problem. The letter gave instructions for continued use until new kits are available.

Device

Device Recall Therakos Photopheresis Procedural Kit for use with the UVAR XTS
  • Model / Serial
    Lot numbers U706, U707, U708, U709, U710, U711, and U712.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide (including AL, AR, AZ, CA, CO, FL, GA, IL, MA, MD, MI, MO, NE, NJ, NY, OK, OR, PA, TN, TX, UT, VA, WA, and WI). Worldwide, including France, Cyprus, Hungary, Saudi Arabia, Singapore, United Kingdom, Austria, Germany, Norway, Italy, Turkey and Portugal.
  • Product Description
    Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125)
  • Manufacturer
    Therakos Inc

Manufacturer

Therakos Inc
  • Manufacturer Address
    Therakos Inc, 429 Creamery Way, Exton PA 19341-2508
  • Source
    USFDA