Recall Z-3328-2026— SPECTRUM MEDICAL SRL
Class II · Ongoing
Class II FDA medical device recall by SPECTRUM MEDICAL SRL, initiated 2026-07-17. It names 2 FDA 510(k) clearances: K223879, K220110. 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..
- Recalling firm
- SPECTRUM MEDICAL SRL
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-17
- Firm location
- Mirandola, Italy
510(k) clearances named in this recall
2 on FDA's record- K223879 — Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
- K220110 — Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Reason for recall
Due to blood-to-glycol leak in the heat exchanger.
Data sourced from openFDA. This site is unofficial and independent of the FDA.