SPECTRUM MEDICAL SRL recalls Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High

Recalling company

SPECTRUM MEDICAL SRL

Product

Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 Model/Catalog Number: HX55W-S0 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 blister pack in a multiple box of 4 units. Device surfaces in contact with blood are treated with a phosphorylcholine-based biocompatible coating. The device has been designed to be powered by heaters coolers that use water or a glycol-based heat transfer fluid (HTF). Component: N/A

Reason

Due to blood-to-glycol leak in the heat exchanger.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Jul 17, 2026

Reported

Oct 7, 2026

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.

Status

Ongoing

Quantity

3232

Lot / codes

Lot Code: 18051160301178 (HX55W-S0)

Company location

Mirandola

Recall type

Voluntary: Firm initiated

Recall number

Z-3328-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3328-2026 in the FDA Enforcement Report. Also see FDA recall press releases.