{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210479", "product_res_number": "Z-0389-2025", "event_date_initiated": "2024-09-20", "event_date_posted": "2024-11-14", "recall_status": "Open, Classified", "res_event_number": "95515", "product_code": "LRO", "product_description": "Halyard GENERAL SET UP PACK - Medical convenience kits\nModel Number: ESJH005-02", "code_info": "GTIN: 10809160400111\n\nLot Number: 1583946", "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": "SAME\n757-566-3510", "reason_for_recall": "Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions", "root_cause_description": "Process control", "action": "Avid Medical issued Urgent: Voluntary Medical Device Recall letter via email on 9/20/24. Letter states reason for recall, health risk and action to take:\nIf you received any of the batches/lots identified in APPENDIX 1, please review your inventory, and discard the entire kit.\nCustomers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have.\nDistributors: If any of the affected kits identified in Appendix 1 were further distributed, please ensure all end-users are appropriately notified of this product correction and maintain records of effectiveness.\n\"Complete the attached Recall Response Form and return as soon as possible.\n\nReport any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com.", "product_quantity": "1,434 eaches", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K881083", "K903336", "K971062", "K941846", "K925467", "K931758", "K962826", "K932652", "K950295", 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"3010376936", "3006271008", "3009888344", "3015895045", "3016761372", "1420054", "3000717925", "3011707784", "3003807323", "1047429", "3005669815", "1000121355", "2433012", "1000208624", "1000112968", "3018071447", "3002806603", "3017430544", "3013466775", "3015058854", "3018116884", "3013735189", "3009773841", "3013298431", "3004122598", "3003495693", "3002805559", "3045857302", "3018077422", "2000028362", "3005595283", "3045816902", "1526711", "1000113384" ], "device_name": "General Surgery Tray", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4370", "device_class": "2" } } ] }