# FDA recall Z-0224-2025

> **Spectrum Medical Ltd.** · Class II · device recall initiated 2023-03-13.

## 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.

## 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.

## Key facts

- **Recall number:** Z-0224-2025
- **Recalling firm:** Spectrum Medical Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2023-03-13
- **Report date:** 2024-10-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gloucester, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0224-2025

## Citation

> AI Analytics. FDA recall Z-0224-2025. Retrieved 2026-09-21 from https://api.ai-analytics.org/recall/Z-0224-2025. Source: US FDA. Licensed CC0.

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