Events

Recall of Device Recall Thermedx Fluid Management System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Thermedx LLC.

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
    68986
  • Event Risk Class
    Class 2
  • Event Number
    Z-2555-2014
  • Event Initiated Date
    2014-02-10
  • Event Date Posted
    2014-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129203
  • 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
    Vacuum powered body fluid collection Kit - Product Code OJR
  • Reason
    A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. the deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded.
  • Action
    Thermedx sent an Urgent Product Correction letter dated March 15, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were notified that the devices were in need of correction, and that it would be performed at their facilities by Thermedx. Customers with questions were instructed to call a Thermedx technical service representative at 1-888-542-9276. For questions regarding this recall call 440-542-0883.

Device

Device Recall Thermedx Fluid Management System
  • Model / Serial
    Model P4000 Serial numbers affected:  20110004, 20110007, 20110015, 20110025, 20130001-20130032, 20140001-20140005
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.
  • Product Description
    The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant.
  • Manufacturer
    Thermedx LLC

Manufacturer

Thermedx LLC
  • Manufacturer Address
    Thermedx LLC, 31200 Solon Rd, Unit 1, Solon OH 44139-3556
  • Manufacturer Parent Company (2017)
    Thermedx LLC
  • Source
    USFDA