{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "161476", "product_res_number": "Z-0781-2018", "event_date_initiated": "2017-06-22", "event_date_created": "2018-02-28", "recall_status": "Terminated", "event_date_terminated": "2018-10-12", "res_event_number": "79162", "product_code": "LRO", "product_description": "AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code: AV010930-12", "code_info": "Lot, Expiration Date: 1205011\t8/1/2019 1213805\t10/1/2019", "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": "Darcy Sisson\n828-338-7568", "reason_for_recall": "Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.", "root_cause_description": "Nonconforming Material/Component", "action": "An email notification was sent to all sales representatives with the BD recall notification and the following instructions: \" Examine inventory for the affected AVID catalog numbers and lots noted in the Where Used Chart. If affected product is found: (1) discontinue use and quarantine impacted product immediately; and (2) promptly apply a recall label to each affected lot found. Once labeled with the recall label, product may be taken out of quarantine and made available for use. \" All other components in the MAI/ AVID tray are unaffected by this recall and may safely be used. Labels may be printed using the label template attached. Or, upon receiving the following information I will be happy to overnight the required labels. Any revisions or alterations to the labels are prohibited.\n\" Label Quantity- 1 for each affected tray, plus 1 for each outside carton.\n\" Contact Name\n\" Address\n\" Phone Number\nSales representatives were asked to confirm to QualityAssurance@owens-minor.com that your customers were notified.", "product_quantity": "200", "distribution_pattern": "Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.", "openfda": { "k_number": [ "K930270", "K964011", "K041080", "K963715", "K970187", "K935858", "K931824", "K930700", "K963443", "K935686", "K920292", "K933137", "K023276", "K925214", "K936117", "K961863", "K885090", "K873973", "K895202", "K934028", "K871322", "K934428", "K952539", "K880961", "K920267", "K884093", "K914935", "K854292", "K931673", "K212258", "K945481", "K925216", "K931760", "K910365", "K874439", "K902888", "K871437", "K935740", "K932220", "K935483", "K934688", "K932221", "K030721", "K962826", "K874760", "K941846", "K882684", "K890726", "K926269", "K950574", 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"2000028362", "3027977504" ], "device_name": "General Surgery Tray", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4370", "device_class": "2" } } ] }