Device recall
Z-0490-2018: Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number…
FDA device recall · Class II · Maquet
Key facts
| Recall number (Z-number) | Z-0490-2018 |
|---|---|
| Recall event | 78765 |
| Product | Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less. |
| Product code | DWE |
| Recalling firm | Maquet |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 12, 2018 |
| 510(k) numbers | K053025 |
| FEI number | 3007066224 |
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