Sarns " TCM II Temperature Control Module The Sarns" TCM II… — Class II medical device recall Z-1569-2013
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2013-07-03. Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assembl
| Recall number | Z-1569-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2013-05-30 |
| Classified | 2013-06-21 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2013-09-17 |
| Countries outside the US | AE, HK, TH |
| Quantity | 7 units |
| Serial numbers | 4656, 4657, 4658, 4659, 4661, 4662, 4663 |
| Model numbers | 4416 |
Product
Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature
Reason for recall
Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1569-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.