Class II — Spectrum Medical Ltd.
| Recalling firm | Spectrum Medical SRL |
|---|---|
| Registered facility | SPECTRUM MEDICAL SRL (the firm's only registered facility) |
| Classification | Class II |
| Status | Completed |
| Reason | The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock. |
| 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 |
| Quantity | 172 units |
| Distribution | US Nationwide distribution including in the states of Alabama, California, Florida, Kentucky, Maine, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, West Virginia. |
| Initiated | 2023-03-13 |
| Classified | 2024-10-24 |
| Recall number | Z-0224-2025 |
| 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 Ltd. (Z-0224-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95428/
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