Quantum Perfusion Systems for CPB — Class II medical device recall Z-0224-2025
Completed recall by Spectrum Medical Ltd., reported 2024-10-30, distributed nationwide. The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
| Recall number | Z-0224-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectrum Medical Ltd., Gloucester, N/A, United Kingdom |
| Recall initiated | 2023-03-13 |
| Classified | 2024-10-24 |
| Reported by FDA | 2024-10-30 |
| Distributed | Nationwide (US) |
| Quantity | 172 units |
| UPC / GTIN / UDI-DI | 05060434420770 |
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
Reason for recall
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
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-0224-2025. 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.