{"recall":{"id":"fda-device-99462","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"SPECTRUM MEDICAL SRL recalls 2 products","firm":"SPECTRUM MEDICAL SRL","date":"2026-07-17","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W 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","code":"Lot Code: 18051160302205 (HX55V-S0W)","quantity":"9448","number":"Z-3327-2026","classification":"Class II"},{"name":"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","code":"Lot Code: 18051160301178 (HX55W-S0)","quantity":"3232","number":"Z-3328-2026","classification":"Class II"}],"reason":"Due to blood-to-glycol leak in the heat exchanger.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"9448; 3232","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99462","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"3ec019a36f98b943","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99462","record":[{"status":"Ongoing","city":"Mirandola","state":"","country":"Italy","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99462","recalling_firm":"SPECTRUM MEDICAL SRL","address_1":"Via Di Mezzo 23","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","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.","recall_number":"Z-3327-2026","product_description":"Brand Name: Quantum PureFlow  Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W  Model/Catalog Number: HX55V-S0W  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","product_quantity":"9448","reason_for_recall":"Due to blood-to-glycol leak in the heat exchanger.","recall_initiation_date":"20260717","center_classification_date":"20260929","report_date":"20261007","code_info":"Lot Code: 18051160302205 (HX55V-S0W)","more_code_info":""},{"status":"Ongoing","city":"Mirandola","state":"","country":"Italy","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99462","recalling_firm":"SPECTRUM MEDICAL SRL","address_1":"Via Di Mezzo 23","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","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.","recall_number":"Z-3328-2026","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","product_quantity":"3232","reason_for_recall":"Due to blood-to-glycol leak in the heat exchanger.","recall_initiation_date":"20260717","center_classification_date":"20260929","report_date":"20261007","code_info":"Lot Code: 18051160301178 (HX55W-S0)","more_code_info":""}]}}