{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-01", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "221605", "product_res_number": "Z-3327-2026", "event_date_initiated": "2026-07-17", "event_date_posted": "2026-09-29", "recall_status": "Open, Classified", "res_event_number": "99462", "product_code": "DTR", "k_numbers": [ "K220110", "K223879" ], "product_description": "Brand Name: Quantum PureFlow\r\nProduct Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W\r\nModel/Catalog Number: HX55V-S0W\r\nSoftware Version: N/A\r\nProduct 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.\r\n\r\nQuantum 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).\r\nComponent: N/A", "code_info": "Lot Code: 18051160302205 (HX55V-S0W)", "firm_fei_number": "3016746283", "recalling_firm": "SPECTRUM MEDICAL SRL", "address_1": "Via Di Mezzo 23 23 via di mezzo", "city": "Mirandola", "country": "Italy", "additional_info_contact": "Cameron Schmitt\n1-803-8333964", "reason_for_recall": "Due to blood-to-glycol leak in the heat exchanger.", "root_cause_description": "Process design", "action": "On 07/17/2026, an \"URGENT MEDICAL DEVICE RECALL\" letter was sent via email to customers informing them that, Spectrum Medical S.r.l. has received customer complaints reporting a leak between the blood and glycol compartments of certain adult heat exchangers.\n\nActions to be taken by customers:\nDuring the procedure, the user should monitor the heat exchanger for leakage, which would be evident by a change in colour in the glycol compartment. Below are images of the heat exchanger if a blood-to-glycol leak was to occur. When operating as intended, the glycol compartment should remain clear. If the colour of the glycol compartment changes, then a leak is present between the blood and glycol compartments.\nIf leakage is noted between the blood and glycol compartments of the heat exchanger, the heat exchanger should be immediately replaced in the circuit with a new device. Please return the defective heat exchanger to Spectrum Medical.\nThe contaminated heater-cooler device should also be immediately removed from clinical use and returned to Spectrum Medical for decontamination and inspection. Do not use the heater-cooler with another patient. If leakage has occurred, please contact a Spectrum Medical representative to coordinate device return.\n\nIf leakage into the water compartment occurs when using a third-party heater-cooler, the customer should immediately remove the heater-cooler from clinical use and contact the heater-cooler manufacturer. Spectrum Medical suggests that for customers that use the heat exchanger in combination with a third-party heater-cooler to contact the manufacturer of the heater-cooler to pre-emptively discuss the steps that should be taken if the device is exposed to blood contamination.\n\nFor questions or further assistance - contact Regulatory Affairs Specialist at cameron.schmitt@spectrummedical.com", "product_quantity": "9448", "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.", "openfda": { "k_number": [ "K832417", "K252541", "K200438", "K905500", "K905568", "K021830", "K932251", "K843983", "K240190", "K012898", "K800377", "K853410", "K840045", "K802879", "K781210", "K823451", "K944267", "K032068", "K813264", "K962320", "K914742", "K884560", "K781764", "K850794", "K923311", "K860920", "K853516", "K770017", "K883331", "K840256", "K991137", "K081838", "K212688", "K904171", "K003724", "K240908", "K812093", "K896807", "K913077", "K772117", "K910923", "K833662", "K770018", "K897039", "K020106", "K873561", "K973475", "K880663", "K040355", "K811204", "K802545", "K964571", "K861102", "K860523", "K880451", "K883332", "K220110", "K853791", "K250150", "K953838", "K913691", "K000977", "K770016", "K871774", "K982467", "K852780", "K934355", "K925369", "K931967", "K800717", "K223879", "K883330", "K791430", "K883071", "K900640", "K823533", "K944219", "K162774", "K041979", "K802848", "K162958", "K090555", "K883439", "K831157", "K833555", "K896020", "K173716", "K790756", "K201984", "K870804", "K072583" ], "registration_number": [ "1928237", "3002806603", "1625519", "8010026", "2029275", "1649914", "3017987980", "1721676", "3015136750", "3030125051", "8010762", "2184009", "9617601", "3011554160", "2011171", "2916596", "9681834", "1218444", "3006073153", "9680841", "1724474", "3013267343", "3005941719", "1124841", "3019807891", "3002807090", "3010155661", "1643817", "3003752502", "3016746283", "3044156918", "1319639", "3010163695" ], "fei_number": [ "1000306431", "3001665800", "1928237", "3002806603", "1625519", "3006003617", "3017987980", "1721676", "3015136750", "3000204839", "3030125051", "3002807111", "3011554160", "2011171", "2916596", "3005426550", "3003094851", "1218444", "3006073153", "1000116158", "3002534070", "3013267343", "3019807891", "3010155661", "1643817", "1000138054", "3003752502", "3016746283", "3044156918", "3009649876", "3002808327", "3010163695", "2828" ], "device_name": "Heat-Exchanger, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4240", "device_class": "2" } } ] }