{"recall":{"id":"fda-device-99672","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"AVID Medical, Inc. recalls Halyard IV START KIT NON-STERILE REF: KRIV26-02","firm":"AVID Medical, Inc.","date":"2026-07-14","reported":"2026-09-23","status":"Ongoing","classification":"Class I","products":[{"name":"Halyard IV START KIT NON-STERILE REF: KRIV26-02","code":"Lot Number: 1658437 UDI: 10809160460481","quantity":"288 units","number":"Z-3108-2026","classification":"Class I"}],"reason":"Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"US Nationwide distribution in the state of NE.","nationwide":true,"states":[],"units":"288 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=99672","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"5fbdbd09434dc3d0","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=99672","record":[{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99672","recalling_firm":"AVID Medical, Inc.","address_1":"9000 Westmont Dr","address_2":"N/A","postal_code":"23168-9351","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the state of NE.","recall_number":"Z-3108-2026","product_description":"Halyard IV START KIT NON-STERILE  REF: KRIV26-02","product_quantity":"288 units","reason_for_recall":"Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides","recall_initiation_date":"20260714","center_classification_date":"20260914","report_date":"20260923","code_info":"Lot Number: 1658437 UDI: 10809160460481","more_code_info":""}]}}