{"recall":{"id":"fda-device-99525","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":"2026-09-16","status":"Ongoing","classification":"Class II","products":[{"name":"Halyard IV Start Kit Non-Sterile REF: KRIV26-02","code":"Lot Number:1658438 7/31/2026 UDI: 10809160460481","quantity":"98 Kits","number":"Z-3109-2026","classification":"Class II"}],"reason":"Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the state of NE.","nationwide":true,"states":[],"units":"98 Kits","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=99525","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"89c197a0ad047acc","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=99525","record":[{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99525","recalling_firm":"AVID Medical, Inc.","address_1":"9000 Westmont Dr","address_2":"","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-3109-2026","product_description":"Halyard IV Start Kit Non-Sterile  REF: KRIV26-02","product_quantity":"98  Kits","reason_for_recall":"Convenience kits contain  BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which  lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.","recall_initiation_date":"20260714","center_classification_date":"20260904","report_date":"20260916","code_info":"Lot Number:1658438 7/31/2026 UDI: 10809160460481","more_code_info":""}]}}