Z-2207-2016Class II

HX2" Temperature Management Systems; The Terumo HX2" Temperature Management System provides temperature...

Name: Z-2207-2016 HX2" Temperature Management Systems; The Terumo HX2" Temperature Management System provides temperature...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2016-06-08
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2016-06-08 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of HX2" Temperature Management Systems; The Terumo HX2" Temperature Management System provides temperature control of two independent water circuits that directly... on 2016-06-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2207-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-08
Posted: 2016-07-14
Terminated: 2017-08-04
Recalling firm: Terumo Cardiovascular Systems Corporation
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.
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
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.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: HX2" Temperature Management Systems, P/N 809810, Catalog Number 809810

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2207-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2207-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18
Z-2208-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18
Z-2209-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18
Z-2210-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18

Product code DWC

K071521Class IITerumo Hx2 Temperature Management SystemTerumo Cardiovascular Systems Corp. / cleared 2007-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)