FDA Device recall Z-1417-2018
Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature by Terumo Cardiovascular Systems, citing update to cooler-heater cleaning instructions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1417-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-16 |
| Published | 2018-04-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .
Reason
Update to cooler-heater cleaning instructions.
Identifiers
| code_info | All Lot Codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1417-2018%22
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