Device recall
Z-0348-2017: Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies…
FDA device recall · Class II · Maquet Cardiovascular Us Sales, Llc
Key facts
| Recall number (Z-number) | Z-0348-2017 |
|---|---|
| Recall event | 75271 |
| Product | Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended to circulate water… |
| Product code | DWC |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2019 |
| 510(k) numbers | K031544 |
| FEI number | 3008355164 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database