Z-3327-2026

Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W...

Name: Z-3327-2026 Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W...
Creator: Spectrum Medical Srl
Published: 2026-07-17
License: https://open.fda.gov/license/

Spectrum Medical Srl / initiated 2026-07-17 / Open, Classified

FDA source

Recall record

Recall number: Z-3327-2026
Status: Open, Classified
Initiated: 2026-07-17
Posted: 2026-09-29
Recalling firm: Spectrum Medical Srl
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 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
Product code: DTR Heat-Exchanger, Cardiopulmonary Bypass
Reason for recall: Due to blood-to-glycol leak in the heat exchanger.
FDA root cause: Process design
Action: On 07/17/2026, an "URGENT MEDICAL DEVICE RECALL" letter was sent via email to customers informing them that, Spectrum Medical S.r.l. has received customer complaints reporting a leak between the blood and glycol compartments of certain adult heat exchangers. Actions to be taken by customers: During the procedure, the user should monitor the heat exchanger for leakage, which would be evident by a change in colour in the glycol compartment. Below are images of the heat exchanger if a blood-to-glycol leak was to occur. When operating as intended, the glycol compartment should remain clear. If the colour of the glycol compartment changes, then a leak is present between the blood and glycol compartments. If leakage is noted between the blood and glycol compartments of the heat exchanger, the heat exchanger should be immediately replaced in the circuit with a new device. Please return the defective heat exchanger to Spectrum Medical. The contaminated heater-cooler device should also be immediately removed from clinical use and returned to Spectrum Medical for decontamination and inspection. Do not use the heater-cooler with another patient. If leakage has occurred, please contact a Spectrum Medical representative to coordinate device return. If leakage into the water compartment occurs when using a third-party heater-cooler, the customer should immediately remove the heater-cooler from clinical use and contact the heater-cooler manufacturer. Spectrum Medical suggests that for customers that use the heat exchanger in combination with a third-party heater-cooler to contact the manufacturer of the heater-cooler to pre-emptively discuss the steps that should be taken if the device is exposed to blood contamination. For questions or further assistance - contact Regulatory Affairs Specialist at [email protected]
Quantity in commerce: 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.
Product codes and lots: Lot Code: 18051160302205 (HX55V-S0W)

Product code DTR

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-02. View this recall on fda.gov (opens on fda.gov)