Home / Recalls / Terumo Cardiovascular Systems Corporation / Z-1790-2021

Z-1790-2021 Class II Terminated

Recalled by Terumo Cardiovascular Systems Corporation — Ann Arbor, MI

FDA device recall Z-1790-2021 was initiated by Terumo Cardiovascular Systems Corporation on Apr 16, 2021 and is designated Class II. Reason for recall: Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it… The recall status is terminated (terminated Nov 29, 2023). Affected quantity: 1176 devices.

Recall Details

Product Type
Devices
Report Date
Jun 9, 2021
Initiation Date
Apr 16, 2021
Termination Date
Nov 29, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1176 devices

Product Description

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. Device Name / Model Number: TCM II TUV, 115V (P/N 4415), TCM II TUV, 220V (P/N 4416), Catalog Number: 4416, 164940

Reason for Recall

Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.

Distribution Pattern

Domestic: Foreign: Australia, Belgium, Canada, Chile, China, Colombia, Dominican Republic, England, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), Vietnam

Code Information

All lot numbers distributed from 05/02/1985 thru 06/10/2015

Other recalls by Terumo Cardiovascular Systems Corporation

  • Z-2018-2025 Class II — CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. (May 28, 2025)
  • Z-1492-2025 Class II — Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catal (Mar 3, 2025)
  • Z-1401-2024 Class II — Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Pa (Feb 20, 2024)
  • Z-1345-2023 Class II — CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 (Mar 1, 2023)
  • Z-1346-2023 Class II — CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE (Mar 1, 2023)
  • Z-1347-2023 Class II — CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC (Mar 1, 2023)
  • Z-2350-2021 Class II — Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 8 (Jun 8, 2021)
  • Z-1789-2021 Class II — The Terumo HX2 Temperature Management System provides temperature control of two (Apr 16, 2021)
  • Z-1791-2021 Class II — The Sarns TCM II (system) is a source of temperature-controlled water for blood (Apr 16, 2021)
  • Z-1367-2021 Class II — Consist of a distal connection mechanism (either standard Terumo Ball Quick Conn (Mar 2, 2021)

FDA data resources