| Class 2 Device Recall Sarns " TCM, Temperature Management System | |
Date Initiated by Firm | June 08, 2016 |
Date Posted | July 14, 2016 |
Recall Status1 |
Terminated 3 on August 04, 2017 |
Recall Number | Z-2208-2016 |
Recall Event ID |
74389 |
510(K)Number | K841402 |
Product Classification |
Controller, temperature, cardiopulmonary bypass - Product Code DWC
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Product | Sarns TCM;
The Sarns Temperature Control and Monitor unit (TCM) 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 The TCM with options will also supply water for cardioplegia, freeze water for an ice
supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature.
Product Usage:
The Sarns TCM is indicated for controlling and monitoring patient temperature. |
Code Information |
The Sarns Temperature Control and Monitor unit (TCM), PIN 15747, Catalog Number 15747 |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corporation 6200 Jackson Rd Ann Arbor MI 48103
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For Additional Information Contact | Terumo CVS Technical Support 800-441-3220 Ext. 6932 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | Nonconforming Material/Component |
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) |
Quantity in Commerce | 6412 units |
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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DWC
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