medical MODERATE Updated 2026-10-07

SPECTRUM MEDICAL SRL recalls Brand Name: Quantum PureFlow Product Name: Quantum PureFlow

See all recalls from SPECTRUM MEDICAL SRL →

Recalled 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

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Code: 18051160301178 (HX55W-S0)

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for Brand Name: Quantum PureFlow →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

Related medical Recalls

Philips North America recalls SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T

2026-10-07 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.

Karl Storz Endoscopy recalls HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 0404855

2026-10-07 · Due to incorrect inside packaging label for eyepiece.

ASP Global, LLC. recalls Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET C

2026-10-07 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

ASP Global, LLC. recalls Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15"

2026-10-07 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.