{ "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": "204584", "product_res_number": "Z-0745-2024", "event_date_initiated": "2023-11-10", "event_date_posted": "2024-01-17", "recall_status": "Open, Classified", "res_event_number": "93506", "product_code": "DRS", "k_numbers": [ "K954970" ], "product_description": "20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR", "code_info": "Lot Number: 4398428\n4404690", "firm_fei_number": "1526863", "recalling_firm": "Smiths Medical Asd Inc", "address_1": "6250 Shier Rings Rd", "city": "Dublin", "state": "OH", "postal_code": "43016-1270", "additional_info_contact": "Customer Service\n800-258-5361", "reason_for_recall": "There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.", "root_cause_description": "Nonconforming Material/Component", "action": "An URGENT MEDICAL DEVICE RECALL notification letter dated 11/10/23 was sent to customers.\n\nRequired Actions for Users:\n1. Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility.\n2. Inform potential users of the product in your organization of this notification and complete and return the attached\nresponse form to smithsmedical7166@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification, even if you do not have the affected product and/or it has already been used.\n3. If you have distributed the product further, immediately notify your accounts that receive the product identified in the Affected Items / Table 1 sections of this notification and ask them to contact Sedgwick at 1-855-215-5142 (MF, 8am-5pm ET) to obtain a response form.\n4. If the product has not already been used, please return affected lots to Smiths Medical and Smiths Medical will offer replacement units.\n\nGlobal Complaint Management globalcomplaints@icumed.com\n1-(866)-216-8806\n\nCustomer Service 1-(800)-258-5361", "product_quantity": "31,685 total", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, UAE.", "openfda": { "k_number": [ "K841613", "K921343", "K801048", "K831867", "K921898", "K101518", "K810637", "K910764", "K820186", "K811980", "K052828", "K951722", "K103715", "K873168", "K820046", "K163172", "K823334", "K870301", "K812883", "K855145", "K112203", "K780128", "K781680", "K802179", "K152472", "K813502", "K812758", "K981747", "K101189", "K852652", "K904777", "K152980", "K801138", "K820342", "K821450", "K043065", "K833792", "K820459", "K833094", "K802069", "K780797", "K810009", "K872596", "K123095", "K803096", "K771361", "K920977", "K820676", "K161408", "K841811", "K062342", "K832897", "K851486", "K930888", "K840121", "K902472", "K092644", "K813464", "K792020", "K813267", "K853996", "K900551", "K172458", "K851987", "K151040", "K821416", "K883095", "K831698", "K871371", "K832657", "K102033", "K821894", "K070710", "K813053", "K862344", "K801985", "K120624", "K811538", "K881297", "K780477", "K884919", "K983372", "K851888", "K812530", "K884235", "K864090", "K841788", "K820457", "K882118", "K823286", "K761325", "K830093", "K832907", "K840023", "K091408", "K810735", "K885296", "K850898", "K833271", "K810431", "K061573", "K812884", "K800705", "K833095", "K133624", "K820202", "K981745", "K221782", "K831506", "K820579", "K813137", "K951129", "K810661", "K813549", "K833170", "K854505", "K790407", "K833096", "K843273", "K833171", "K792073", "K780127", "K822507", "K830210", "K851988", "K870356", "K820355", "K801136", "K831348", "K854596", "K800706", "K841960", "K801239", "K860681", "K904601", "K902453", "K840274", "K820201", "K771668", "K820677", "K841968", "K851989", "K843580", "K791636", "K961404", "K842352", "K242909", "K813266" ], "registration_number": [ "", "3017987980", "3005595283", "1649914", "3006891665", "3011237704", "1417592", "3013783488", "1713468", "3012542015", "2025816", "3008496528", "3016701404", "3006950086", "3007048453", "9610849", "8043983", "3007603826", "3009077524", "3014541700", "1625425", "2221819", "9610816", "3009001657", "1718873", "3018094310", "2032112", "3004519921", "3009156722", "2648727", "3003263092", "3016618143", "3004111573", "2936999", "3013500228", "3015309643", "1218950", "1423395", "3013596024", "9616088", "1724474", "3013319212", "3017636737", "3005941719", "3009106351", "9616675", "8010042", "9615817", "3010421104", "2648045", "8020616", "3004832480", "3008693658", "9612152", "1422634", "3000126629", "3002907620", "3032916632", "1423537", "1721504", "1043214", "9617594", "3012528160", "1721676", "3007836437", "3007307487", "3015173212", "1061124", "3008403546", "1018233", "1055236", "3004605321", "3033589330", "3012536737", "8043969", "3015910259", "1526863", "3005580113", "2246552", "3006082230", "9616567", "3015225571", "1928237", "1319639", "3031233007", "1054241", "3005012805", "9681377" ], "fei_number": [ "", "3017987980", "3005595283", "1000138054", "3002902735", "3001236905", "3006891665", "3011237704", "3004050362", "1417592", "3013783488", "1713468", "3012542015", "2025816", "3002807391", "3008496528", "1000514656", "3016701404", "3006950086", "3007048453", "3005846326", "3007603826", "3009077524", "3014541700", "3002807111", "3002807167", "1625425", "2221819", "3003076831", "3009001657", "1718873", "3018094310", "1000300598", "3009156722", "2648727", "3003081151", "3003263092", "3016618143", "3004111573", "2936999", "3013500228", "3015309643", "3003105967", "1218950", "3013596024", "3002808128", "3013319212", "3002806476", "3017636737", "3009106351", "3010421104", "3001665800", "2648045", "3004832480", "3008693658", "3000126629", "3002907620", "3032916632", "1721504", "1043214", "1000112968", "3002963732", "3012528160", "1721676", "3016261803", "3007836437", "3007307487", "1000512168", "3015173212", "3000717925", "3008403546", "1018233", "3004605321", "1000112877", "3002806901", "3033589330", "3012536737", "3015910259", "1526863", "3005580113", "2246552", "3006082230", "3015225571", "3003094851", "1928237", "3031233007", "3005012805", "3003807466" ], "device_name": "Transducer, Blood-Pressure, Extravascular", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2850", "device_class": "2" } } ] }