{"recall":{"id":"fda-device-98777","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Spectra Medical Devices, Llc recalls Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection","firm":"Spectra Medical Devices, Llc","date":"2026-07-06","reported":"2026-08-19","status":"Ongoing","classification":"Class I","products":[{"name":"Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.","code":"Lot Code: Product codes: 1510-1 (individual ampule) / 1510-2 (carton) Lots: AB3005, AB3006, AB3007, AB3008, AB3009, AB3010, AB4001, AB4002, AB4003, AB4004, AB4005 AB4006, AB5001, AB5002, AB5003, AB5004, AB5005,AB5006, AB5007, AB5008 No individual UDI, as this product is used only within convenience kits.","quantity":"TBD","number":"Z-2873-2026","classification":"Class I"}],"reason":"Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.","nationwide":false,"states":["CA","FL","NC","OK","TX","VA"],"units":"TBD","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=98777","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"7bbc4cb8b5c2bf6b","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=98777","record":[{"status":"Ongoing","city":"Wilmington","state":"MA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"98777","recalling_firm":"Spectra Medical Devices, Llc","address_1":"299 Ballardvale St","address_2":"Ste 1","postal_code":"01887-1066","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.","recall_number":"Z-2873-2026","product_description":"Brand Name: Elevaris/Spectra Medical Devices  Product Name: Sodium Chloride Injection, 0.9%, USP 10mL  Ampule  Model/Catalog Number: AMPUL10MLK.     Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.","product_quantity":"TBD","reason_for_recall":"Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.","recall_initiation_date":"20260706","center_classification_date":"20260811","report_date":"20260819","code_info":"Lot Code: Product codes: 1510-1 (individual ampule) / 1510-2 (carton)    Lots:  AB3005, AB3006, AB3007, AB3008, AB3009, AB3010, AB4001, AB4002, AB4003, AB4004, AB4005 AB4006, AB5001, AB5002, AB5003, AB5004, AB5005,AB5006, AB5007, AB5008  No individual UDI, as this product is used only within convenience kits.","more_code_info":""}]}}