FDA Device recall Z-1791-2021
The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for b…
- FDA Device
- Class II
- terminated
- Published 2021-06-09
On 2021-06-09 the FDA classified a Class II recall of The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for b… by Terumo Cardiovascular Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1791-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-16 |
| Published | 2021-06-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | n/a |
Product
The Sarns TCM II (system) 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. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature. The Sarns" TCM II also features a Cardioplegia System which will supply cooling water for cardioplegia. Device Name / Model Number: TCM II, with Cardioplegia, 110V/60Hz (P/N 164925) TCM II, without Cardioplegia, 110V/60Hz (P/N 164930) TCM II, with Cardioplegia, 220V/50Hz (P/N 164935) TCM II, without Cardioplegia, 220V/50Hz (P/N 164940) TCM (P/N 15747) Catalog Number: 4415, 164925, 164930, 164935, 15747
Reason
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.
Identifiers
| code_info | All lot numbers distributed from 05/02/1985 thru 06/10/2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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All Terumo Cardiovascular Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1791-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.