FDA Device recall Z-0224-2025
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing
- FDA Device
- Class II
- completed
- Published 2024-10-30
On 2024-10-30 the FDA classified a Class II recall of Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing by Spectrum Medical, citing the ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0224-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-03-13 |
| Published | 2024-10-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Spectrum Medical |
| Distribution | US |
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
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
Identifiers
| code_info | UDI/DI 05060434420770: Serial Numbers: a) AU6004040, AU6004041, AU6004042, AU6004043, AU6004044, AU6004046, AU6004050…UDI/DI 05060434420770: Serial Numbers: a) AU6004040, AU6004041, AU6004042, AU6004043, AU6004044, AU6004046, AU6004050, AU6004051, AU6004052, AU6004053, AU6004054, AU6004056, AU6004057, AU6004058, AU6004060, AU6004061, AU6004062, AU6004063, AU6004064, AU6004065, AU6004066, AU6004069, AU6004070, AU6004071, AU6004072, AU6004073, AU6004074, AU6004075, AU6004136, AU6004137, AU6004138, AU6004139, AU6004140, AU6004141, AU6004142, AU6004143, AU6004144, AU6004145, AU6004146, AU6004147, AU6004148, AU6004159, AU6004160, AU6004161, AU6004162, AU6004167, AU6004168, AU6004169, AU6004170, AU6004171, AU6004172, AU6004173, AU6004174, AU6004175, AU6004176, AU6004177, AU6004178, AU6004179, AU6004180, AU6004181, AU6004182, AU6004183, AU6004184, AU6004185, AU6004186, AU6004187, AU6004188, AU6004195, AU6004197, AU6004198, AU6004200, AU6004201, AU6004202, AU6004203, AU6004204, AU6004205, AU6004207, AU6004332, AU6004333, AU6004348, AU6004349, AU6004350, AU6004352, AU6004353, AU6004354, AU6004532, AU6004577, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0224-2025%22
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