# Class II recall Z-3327-2026: SPECTRUM MEDICAL SRL

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3327-2026 |
| Recalling firm | SPECTRUM MEDICAL SRL |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Brand Name: Quantum PureFlow  Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W  Model/Catalog Number: HX55V-S0W  Software Version: N/A  Product Description: The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration with a maximum flow rate of 8 l/min.    Quantum PureFlow Standard Heat Exchanger is a single use device which allows heating/cooling the blood during extracorporeal circulation. The device is sold sterile in a blis |
| Reason | Due to blood-to-glycol leak in the heat exchanger. |
| Quantity | 9448 |
| Distribution | US Nationwide distribution in the states of AL, CA, FL, KS MA, MD, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WI. |
| Recall initiated | 2026-07-17 |
| Reported | 2026-10-07 |
| Firm location | Mirandola, Italy |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 29 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3327-2026%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.