Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR… — Class II medical device recall Z-0629-2018
Terminated recall by Cincinnati Sub-Zero Products LLC, reported 2018-02-21, distributed nationwide. Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/c
| Recall number | Z-0629-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cincinnati Sub-Zero Products LLC, Cincinnati, OH, United States |
| Recall initiated | 2017-11-27 |
| Classified | 2018-02-15 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2018-07-02 |
| Distributed | Nationwide (US) |
| Quantity | 1,355 units |
| Model numbers | 400CE, 400MR |
Product
Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.
Reason for recall
Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure.
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-0629-2018. 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.