FDA Device recall Z-1416-2018
Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply te…
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply te… by Terumo Cardiovascular Systems, citing update to cooler-heater cleaning instructions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1416-2018 |
| 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
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.
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-1416-2018%22
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