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
Class II- Recalling firm
- SPECTRUM MEDICAL SRL
- Reason for recall
- Due to blood-to-glycol leak in the heat exchanger.
- Affected products (lot / model / serial)
- Lot Code: 18051160301178 (HX55W-S0)
- Units affected
- 3232
- Distribution pattern
- 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.
- Firm location
- Mirandola, Italy
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3328-2026
- Recall initiated
- July 17, 2026
- FDA classification date
- September 29, 2026
- FDA report date
- October 7, 2026
- FDA event ID
- 99462
- Last updated on HTM Vibe
- October 13, 2026