FDAFDA · Alimentos y medicamentos·N.º oficial Z-3328-2026
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
Publicado el 7 de octubre de 2026 · Inicio del retiro: 17 de julio de 2026
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Due to blood-to-glycol leak in the heat exchanger.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- SPECTRUM MEDICAL SRL
- Distribuidor
- 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.
- Lote
- Lot Code: 18051160301178 (HX55W-S0)
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Italy
Retiros relacionados
- FDABrand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/C…7 de octubre de 2026
- FDAOlympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction w…7 de octubre de 2026
- FDAPipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he P…7 de octubre de 2026
- FDABrand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Numbe…7 de octubre de 2026
- FDAIntrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC7 de octubre de 2026
- FDABrand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion …7 de octubre de 2026
- FDATravel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual7 de octubre de 2026
- FDASystems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: …7 de octubre de 2026
Preguntas sobre este retiro
¿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 fue retirado del mercado?
Sí. FDA publicó el retiro Z-3328-2026 el 7 de octubre de 2026. Peligro reportado: Due to blood-to-glycol leak in the heat exchanger.
¿Qué debo hacer si tengo este producto?
Voluntary: Firm initiated · Letter
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.
Recalert también vigila fechas de caducidad para que vendas el inventario antes de que se convierta en pérdida.