Maquet Medical Systems USA Recall 88285
Description: 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.
Maquet Medical Systems USA Recall 88285 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2140-2021 |
| Event ID | 88285 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH. |
| Quantity | 33 |
| Recall 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. |
| Device Classification | 20210804 |
| Device 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 70103.4653HCU 30 Base Unit 200-240 V, Model Number 939001 I 70102.8718 All serial numbers are affected. |
| Center Classification Date | 20210723 |
| Recall Initiation Date | 20210714 |
| Recalling Firm | Maquet Medical Systems USA |
| Initial Notification | Letter |
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