FDA Device recall Z-2140-2021
Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers…
- FDA Device
- Class II
- terminated
- Published 2021-08-04
On 2021-08-04 the FDA classified a Class II recall of Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers… by Maquet Medical Systems Usa, citing there is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2140-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-14 |
| Published | 2021-08-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Maquet Medical Systems Usa |
| Distribution | AL, CA, FL, IL, KS, MI, MO, NC, NE, OH |
Product
Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.
Reason
There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
Identifiers
| code_info | HCU 30 Base Unit 100-120 V, Model Number 704629 I 70103.4371 HCU 30 Base Unit Canadian/US, Model Number 705501 I 70103.…HCU 30 Base Unit 100-120 V, Model Number 704629 I 70103.4371 HCU 30 Base Unit Canadian/US, Model Number 705501 I 70103.4653HCU 30 Base Unit 200-240 V, Model Number 939001 I 70102.8718 All serial numbers are affected. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2140-2021%22
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