{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "222151", "product_res_number": "Z-3108-2026", "event_date_initiated": "2026-07-14", "event_date_posted": "2026-09-14", "recall_status": "Open, Classified", "res_event_number": "99672", "product_code": "LRO", "product_description": "Halyard IV START KIT NON-STERILE\r\nREF: KRIV26-02", "code_info": "Lot Number: 1658437\nUDI: 10809160460481", "firm_fei_number": "1047429", "recalling_firm": "AVID Medical, Inc.", "address_1": "9000 Westmont Dr", "city": "Toano", "state": "VA", "postal_code": "23168-9351", "additional_info_contact": "Marlene Jones\n+1-470-2804277", "reason_for_recall": "Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides", "root_cause_description": "Packaging process control", "action": "On August 18, 2026, Avid Medical Inc. a subsidiary of Owens Minor issued an \"Urgent Medical Device Recall Update\" to affected consignees via email. The update was due to a revise recall strategy. Initial notification was sent on July 14, 2026. Avid ask consignees to take the following actions: \n\n1. Identify, segregate, and quarantine all impacted product identified in TABLE 1.\n2. Discontinue use of the BD ChloraPrep Clear - 1 mL and FREPP\" Clear 1.5 mL Applicators.\n3. FOR AVID KIT KRIV26-02, IV START KIT NON-STERILE, KIT LOT 1658437: Discard entire kit as it contains the contaminated component BD ChloraPrep\" Clear - 1 mL, BD LOT 4032183.\n4. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have.\n5. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified of the actions to take and maintain records of effectiveness.\n6. Complete the attached Recall Response Form and return by August 28, 2026.\n\nIf you have any questions, contact Manager, Regulatory Affairs at 470-280-4277.", "product_quantity": "288 units", "distribution_pattern": "US Nationwide distribution in the state of NE.", "openfda": { "k_number": [ "K890098", "K931844", "K890729", "K932217", "K880942", "K944044", "K930700", "K931673", "K871459", "K883250", "K914037", "K890726", "K950574", "K882684", "K914036", "K951478", "K920292", "K934688", "K952539", "K895202", "K963443", "K931760", "K041080", "K961683", "K964921", "K854095", "K871873", "K933137", "K892389", "K935740", "K934029", "K893814", "K964011", "K914174", "K872011", "K023276", "K971062", "K922133", "K890570", "K902888", "K925214", "K965201", "K941846", "K931759", "K934028", "K951149", "K932220", "K963715", "K935741", "K922648", "K932652", "K931758", "K920267", "K923600", "K934030", "K980137", "K873973", "K931820", "K871434", "K212258", "K890658", "K854292", "K871322", "K970286", 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"device_class": "2" } } ] }