Reported Oct 7, 2026 · Ongoing · Updated Oct 13, 2026
Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog…
Spectrum Medical Srl
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SPECTRUM MEDICAL SRL · Via Di Mezzo 23 · Mirandola · N/A
Is this the product you have?
- Brand NameQuantum
- PureFlow Product NameQuantum PureFlow Standard Heat Exchanger
- High Flow 3/8 W Model/Catalog NumberHX55V-S0W
- Software VersionN/A
- Product DescriptionThe 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)
- ComponentN/A
- Lot codes and dates
- Lot Code18051160302205 (HX55V-S0W)
- Amount recalled
- 9448
Where it was sold
Why it was recalled
Due to blood-to-glycol leak in the heat exchanger.
This product could cause temporary or reversible health problems — stop using it.
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