Device recall
Z-0224-2025: Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel…
FDA device recall · Class II · Spectrum Medical Ltd.
Key facts
| Recall number (Z-number) | Z-0224-2025 |
|---|---|
| Recall event | 95428 |
| Product | Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00 |
| Product code | DTQ |
| Recalling firm | Spectrum Medical Ltd. |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K173834 |
| FEI number | 3006073153 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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