Recall Z-0224-2025— Spectrum Medical Ltd.
Class II · Completed
Class II FDA medical device recall by Spectrum Medical Ltd., initiated 2023-03-13. It names one FDA 510(k) clearance: K173834. 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..
- Recalling firm
- Spectrum Medical Ltd.
- Classification
- Class II
- Status
- Completed
- Initiated
- 2023-03-13
- Firm location
- Gloucester, N/A, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.