Events

Recall of Device Recall Sarns TCM II, Temperature Management System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corporation.

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
    74389
  • Event Risk Class
    Class 2
  • Event Number
    Z-2209-2016
  • Event Initiated Date
    2016-06-08
  • Event Date Posted
    2016-07-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147334
  • 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
    Controller, temperature, cardiopulmonary bypass - Product Code DWC
  • Reason
    Terumo cardiovascular systems (terumo cvs) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the interchlor sanitizer (product code 205) referenced in its heater-cooler cleaning instructions.
  • Action
    Terumo Cardiovascular Systems (Terumo CVS) initiated a voluntary recall on 06/08/2016, by mailing certifed letters to customers. Terumo CVS is notifying all users of its heater-cooler devices that the distributor, Intercon Chemical Company, no longer sells the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions. However, the identical sanitizer is available from other sources. This notice applies to the following Terumo CVS heater-cooler devices: ¿ Sarns" TCM and TCM II Cooling and Heating Systems ¿ Sarns" Dual Cooler-Heaters ¿ HX2" Temperature Management Systems Terumo CVS will provide users with updated user instructions regarding the 10% Sodium Hypochlorite sanitization solution. Instructions will be provided under separate cover, when available; updated manual and cleaning guide will be completed in December 2016. Customers are asked to do the following: Review this notice and ensure that all users receive notice of this issue. 2. Return the attached Customer Response Form acknowledging receipt of this notice. 3. Source a replacement for the Interchlor sanitizer. See information above or call Terumo CVS Technical Support for assistance. If you have questions about this notification, please contact your Terumo representative or Terumo CVS Technical Support: 800.441.3220, extension 6932 Technical Support Hours: Monday  Friday 8 a.m.  6 p.m. ET (24/7 Emergency Hours)

Device

Device Recall Sarns TCM II, Temperature Management System
  • Model / Serial
    The Sarns Temperature Control and Monitor unit (TCM), TCM II TUV, 115V (P/N 4415), TCM II TUV, 220V (P/N 4416), TCM II, with Cardioplegia, 11 OV/60Hz (P/N 164925) TCM II, without Cardioplegia, 110V/60Hz (P/N 164930) TCM II, with Cardioplegia, 220V/50Hz (P/N 164935) TCM II, without Cardioplegia, 220V/50Hz (P/N 164940)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic: AK, AL, AR, AZ, CA , CO, CT, DC , DE , FL, GA, HI, IA, ID, IL, IN, KS, KY,LA , MA, MD, ME, MI , MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV , NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY Foreign: Argentina, Australia, Belgium,Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, England, Finland, France, Germany Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Malaysia Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates , Uruguay , Venezuela, Vietnam
  • Product Description
    Sarns TCM II; || The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source of temperature controlled water for blood heat exchangers used in an || extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood || temperature. || Product Usage: || The Sarns TCM II is indicated for controlling and monitoring patient temperature.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Rd, Ann Arbor MI 48103
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA