{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221740", "product_res_number": "Z-3109-2026", "event_date_initiated": "2026-07-14", "event_date_posted": "2026-09-04", "recall_status": "Open, Classified", "res_event_number": "99525", "product_code": "LRO", "product_description": "Halyard IV Start Kit Non-Sterile\r\nREF: KRIV26-02", "code_info": "Lot Number:1658438 7/31/2026\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\n470-280-4277", "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.", "root_cause_description": "Packaging process control", "action": "On July 14, 2026, Avid Medical Inc. a subsidiary of Owens Minor issued an Urgent Medical Device Recall to affected consignees via email. I Avid Medical Inc. requested consignees to take the following actions: \n\n1. Identify, segregate, and quarantine all impacted product identified.\n1a. Discontinue use of the BD ChloraPrep\" Clear - 1 mL and FREPP\" Clear 1.5 mL Applicators.\n1b. Add warning labels to affected AVID kits to ensure all users are aware of the actions to discard the impacted component prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical\nproduct information found on existing product labeling.\n2. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have.\n3. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness.\n4. Complete the attached Recall Response Form and return by July 31, 2026.", "product_quantity": "98 Kits", "distribution_pattern": "US Nationwide distribution in the state of NE.", "openfda": { "k_number": [ "K970187", "K871434", "K890570", "K902887", "K935741", "K935740", "K023276", "K931758", "K980137", "K950574", "K945831", "K872448", "K890726", "K872011", "K914037", "K914036", "K920267", "K932221", "K924468", "K895202", "K931760", "K951149", "K961863", "K920292", "K854292", "K934428", "K874439", "K910365", "K963443", "K913136", "K890729", "K934028", "K854095", "K881083", "K871459", "K871322", "K905004", "K894685", "K935483", "K971061", "K935686", "K041080", "K964921", "K885090", "K213481", "K892389", "K925467", "K944044", "K970286", "K212258", "K963715", "K905459", "K951478", "K931824", "K902293", "K925016", "K922648", "K903336", "K934029", "K961683", "K931844", "K930700", "K871873", "K932652", "K030721", "K925214", "K932217", "K880942", "K971062", "K930270", "K874760", "K890658", 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