Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with… — Class II medical device recall Z-1327-2025
Ongoing recall by Spectrum Medical Inc, reported 2025-03-19, distributed nationwide. Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or dur
| Recall number | Z-1327-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectrum Medical Inc, Fort Mill, SC, United States |
| Recall initiated | 2025-01-16 |
| Classified | 2025-03-13 |
| Reported by FDA | 2025-03-19 |
| Distributed | Nationwide (US) |
| Quantity | 1,487 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 08051160300624 |
| Lot numbers | F000961, G001207, G001256, G001511 |
| Model numbers | CP22V-VT |
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 for recall
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1327-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.