Device recall
Z-1327-2025: Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated…
FDA device recall · Class II · Spectrum Medical Inc
Key facts
| Recall number (Z-number) | Z-1327-2025 |
|---|---|
| Recall event | 96240 |
| Product | Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A |
| Product code | KFM |
| Recalling firm | Spectrum Medical Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K201320 |
| FEI number | 3006126428 |
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