# FDA recall Z-1327-2025

> **Spectrum Medical Inc** · Class II · device recall initiated 2025-01-16.

## Product

Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors  Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type  Model/Catalog Number: CP22V-VT  Software Version: N/A

## Reason for recall

Their is a potential of fluid leakage from the centrifugal blood pump  pump during the priming procedure or during clinical procedures.

## Distribution

US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, and Washington.

## Key facts

- **Recall number:** Z-1327-2025
- **Recalling firm:** Spectrum Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-16
- **Report date:** 2025-03-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fort Mill, SC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1327-2025

## Citation

> AI Analytics. FDA recall Z-1327-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1327-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*