Z-2210-2016Class II

Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for...

Name: Z-2210-2016 Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for...
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 Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers... 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 Inter chlor 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-2210-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-08
Posted: 2016-07-14
Terminated: 2017-08-04
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers during open heart surgery. It supplies water at a rate of up to 6.5 gallons per minute (25 liters per minute) at zero head, and will provide a maximum pressure output of 11 pounds per square inch (76,000 pascals). The Sarns TM Dual Cooler-Heater can be used with heat exchangers capable of accepting these flows and pressures. Product Usage: The Sarns Dual Cooler-Heater is indicated for use as a water supply system to a blood heat exchanger in 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 Inter chlor 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: The Sarns Dual Cooler-Heater ; Dual Cooler Heater 115V/60Hz (P/N 11160); Dual Cooler Heater 220V/50Hz (P/N 4332); Dual Cooler Heater 1 OOV/60Hz (P/N 14114); Dual Cooler Heater 1 OOV/50Hz (PIN 13460)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2210-2016
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

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)