Z-1416-2018Class II

Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is...

Name: Z-1416-2018 Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2018-03-16
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2018-03-16 / Terminated / root cause: labeling and UDI

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated... on 2018-03-16. FDA classified it as Class II and gives the reason as "Update to cooler-heater cleaning instructions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1416-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-16
Posted: 2018-04-18
Terminated: 2020-06-10
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System 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: Update to cooler-heater cleaning instructions.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: The firm,Terumo Cardiovascular Systems Corporation, mailed customers an "Urgent Medical Device Correction" letter dated 2/16/18. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following: 1) discard the current Sarns TCM, TCM II Cooling and Heating, or tHX2 Temperature Management Systems cleaning guides; 2) Review the notice and updated cleaning guides, and ensure all users receive notice of the updated cleaning guides and; 3) Return the Customer Response Form acknowledging receipt of the notice via Terumo Recall Email: [email protected] or Terumo Recall Fax: 734-741-6149. The letter also includes a list of the updates to the cleaning guides. Customers with questions may contact Terumo CVS Customer Service (800) 521-2818, Monday-Friday, 8am-6pm ET or Fax (734)741-6149.
Quantity in commerce: 2393 this total is for all products
Distribution: Worldwide Distribution: US (Nationwide), Australia, Belgium, Canada, Chile, China. Colombia, Dominican Republic, England, Finland, France, Germany, Greece, HK, India, Indonesia, Iran. Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates,and Vietnam.
Product codes and lots: All Lot Codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1416-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1416-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1417-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1418-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17

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)