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Brand Name: Quantum PureFlow recallZ-3328-2026 · Spectrum Medical Srl · initiated Jul 17, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Spectrum Medical Srl or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process design

What the company is doing

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]

Recall details

Recall number
Z-3328-2026
Status
Open, Classified
Initiated by the company
Jul 17, 2026
Posted by the FDA
Sep 29, 2026
Recalling firm
Spectrum Medical Srl
Quantity
3232
Product code
DTR
FDA submissions
K220110, K223879
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 description

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

Code information (models, lots, serial numbers)

Lot Code: 18051160301178 (HX55W-S0)

Other devices under the same FDA submission

2 devices cleared under K220110, K223879 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99462).

Sources and updates

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