—#147332

Product

HX2" Temperature Management Systems; The Terumo HX2" Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right).The system has the capacity to circulate water at a rate of up to 6.5 gal.min (25 L/min) with no load connected. The system is capable of heating and cooling for a single channel or for both channels. Product Usage: HX2 Temperature Management Systems is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.

FDA product code: DWC — Controller, Temperature, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K071521
Affected lot / code info: HX2" Temperature Management Systems, P/N 809810, Catalog Number 809810

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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)

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2016-06-08
Posted by FDA: 2016-07-14
Terminated: 2017-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147332. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.