{ "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": "2026-09-24", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "222429", "product_res_number": "Z-3260-2026", "event_date_initiated": "2026-07-22", "event_date_posted": "2026-09-23", "recall_status": "Open, Classified", "res_event_number": "99764", "product_code": "LRO", "product_description": "Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02", "code_info": "Kit Model Number: KRIV26-02. UDI-DI: 10809160460481. Lot Numbers (Expiration Date): 1658438 (07/31/2026), 1685838 (12/19/2027), 1699753 (02/28/2027), 1706455 (12/19/2027).", "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 containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.", "root_cause_description": "Packaging process control", "action": "Consignees were initially notified on about 07/22/2026 via \"URGENT: MEDICAL DEVICE FIELD CORRECTION\" letter. They were informed that product may exhibit an open or incomplete seal on the packaging of the applicator. Consignees were instructed to quarantine impacted product, discontinue use of the BD ChloraPrep Clear - 1 mL Applicators within the kits, add a warning label to instruct users to discard the impacted component, and notify customers if the kits had been further distributed. \n\nConsignees were notified again on about 08/20/2026 with an updated \"URGENT: MEDICAL DEVICE FIELD CORRECTION\" letter. Consignees were informed that certain lots of the BD ChloraPrep Applicators are contaminated with Aspergillus penicillioides. Instructions included to discard impacted kits containing affected applicators and notify customers if the kits had been further distributed. For those unaffected by the contamination, but are included in the action regarding sterility concerns, they were instructed to quarantine impacted product, discontinue use of the BD ChloraPrep Clear - 1 mL Applicators within the kits, add a warning label to instruct users to discard the impacted component, and notify customers if the kits had been further distributed.", "product_quantity": "816 kits (17 cases)", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K965201", "K884093", "K922133", "K964011", "K881083", "K023276", "K951149", "K963721", "K961863", "K871434", "K971062", "K934028", "K933137", "K890658", "K935740", "K030721", "K925216", "K882684", "K914036", "K890570", "K910365", "K905459", "K934030", "K935686", "K914935", "K854292", "K963443", "K926269", "K944044", "K905004", "K945481", "K842648", "K871437", "K213481", "K934688", "K880942", "K871322", "K932652", "K902293", "K874439", "K953083", "K920292", "K871873", "K885090", "K914174", 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"3000215259", "3011545608", "3015058854", "3005595283" ], "device_name": "General Surgery Tray", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4370", "device_class": "2" } } ] }