{"recall":{"id":"fda-device-99343","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Baxter Healthcare Corporation recalls Baxter Duo-Vent Solution Set and Male Luer Lock Adapter","firm":"Baxter Healthcare Corporation","date":"2026-06-30","reported":"2026-08-19","status":"Ongoing","classification":"Class I","products":[{"name":"Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets","code":"UDI/DI 00085412014319, Lot Numbers: DR26C27062, exp. 30-MAR-2028; DR26D14031, exp. 15-Apr-2028; DR26E13055, exp. 14-May-2028","quantity":"24528 units","number":"Z-2766-2026","classification":"Class I"}],"reason":"Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"US Nationwide. No OUS consignees.","nationwide":true,"states":[],"units":"24528 units","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=99343","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"1d0cc9ad912a4c5c","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=99343","record":[{"status":"Ongoing","city":"Deerfield","state":"IL","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99343","recalling_firm":"Baxter Healthcare Corporation","address_1":"1 Baxter Pkwy","address_2":"","postal_code":"60015-4625","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide. No OUS consignees.","recall_number":"Z-2766-2026","product_description":"Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets","product_quantity":"24528 units","reason_for_recall":"Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.","recall_initiation_date":"20260630","center_classification_date":"20260811","report_date":"20260819","code_info":"UDI/DI 00085412014319, Lot Numbers:  DR26C27062, exp. 30-MAR-2028; DR26D14031, exp. 15-Apr-2028; DR26E13055, exp. 14-May-2028","more_code_info":""}]}}