Class II — Spectrum Medical Inc
| Recalling firm | Spectrum Medical SRL |
|---|---|
| Registered facility | SPECTRUM MEDICAL SRL (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures. |
| 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 |
| Quantity | 1487 unit |
| Distribution | US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, and Washington. |
| Initiated | 2025-01-16 |
| Classified | 2025-03-13 |
| Recall number | Z-1327-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Spectrum Medical Inc (Z-1327-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96240/
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