FDA Device recall Z-1327-2025
Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Ro…
- FDA Device
- Class II
- ongoing
- Published 2025-03-19
On 2025-03-19 the FDA classified a Class II recall of Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Ro… by Spectrum Medical, citing their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1327-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-16 |
| Published | 2025-03-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Spectrum Medical |
| Distribution | US |
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
Reason
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
Identifiers
| code_info | Lot Code: Model No CP22V-VT; UDI-DI 08051160300624; Lot Numbers F000961, G001207, G001256, G001511 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1327-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.