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
    58744
  • Event Risk Class
    Class 2
  • Event Number
    Z-2994-2011
  • Event Initiated Date
    2011-03-31
  • Event Date Posted
    2011-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100212
  • 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
    Increased complaints were received of tubing leaks at the junction between the tubing and fluid logic module plastic ports of the kits.
  • Action
    The firm, Therakos Photopheresis, sent a "URGENT PRODUCT CORRECTION NOTIFICATION" letter dated March 31, 2011 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to immediately discontinue using the affected products; deface and discard their remaining inventory of affected procedural kits, following their internal procedures for destroying and discarding of medical waste, and complete and return the attached Confirmation of Receipt Form no later than 08-April-2011 via fax to: Safety, Risk Management and Surveillance at 1-888-557-3759 or 1-585-453-4110. If you have any additional technical questions, please contact Therakos Customer Service Center at 1-800-828-6316. If you have technical questions regarding this communication, please call Therakos Technical Support at 1-877-865-6850.

Device

Device Recall THERAKOS UVAR XTS Procedural Kits
  • Model / Serial
    XT125 Procedural Kit (X752-X760 and Y701-Y753) and XT001 Procedural Kit (X919 and Y901-Y911)
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD,TN, TX, UT, VA, VT, WA, and WI; and countries of: Argentina, Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Korea, Kingdom of Saudi Arabia, Jordan, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom.
  • Product Description
    XT125 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT; XT001 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT || Single-use, disposable, closed system with sterile fluid pathways. The device collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittenly returns the remaining plasma and erythocytes to the patient.
  • Manufacturer
    Therakos, Inc.

Manufacturer

Therakos, Inc.
  • Manufacturer Address
    Therakos, Inc., 440 Us Highway 22 Ste 140, Bridgewater NJ 08807-2477
  • Manufacturer Parent Company (2017)
    Mallinckrodt Plc
  • Source
    USFDA