{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 6 } }, "results": [ { "cfres_id": "218311", "product_res_number": "Z-1463-2026", "event_date_initiated": "2026-01-08", "event_date_posted": "2026-02-24", "recall_status": "Open, Classified", "res_event_number": "98333", "product_code": "LRO", "product_description": "Medline Kits containing Tego Connectors:\nMedline IR Pack, SKU DYNJ67205C\nMedline NO CATHETER DIALYSIS INSERTION, SKU CVI5200", "code_info": "IR PACK\nUDI-DI (ea) 10195327621780\nUDI-DI (case) 40195327621781\nKit lots\n24BBP627\n24DBO029\n24FBI148\n24JBA858\n24KBD925\n24LBG978\n25ABQ002\n25EBV162;\n\nNO CATHETER DIALYSIS INSERTION\nUDI-DI (ea) 10195327675219\nUDI-DI (case) 40195327675210\nKit Lots\n24EBM915\n24GBC287", "firm_fei_number": "1417592", "recalling_firm": "Medline Industries, LP", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Haley Barclay\n800-633-5463", "reason_for_recall": "Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.", "root_cause_description": "Process control", "action": "On January 8, 2026, the firm notified affected customers of the product issue through email and first class mail.\n\nCustomers were instructed to request stickers to over-label affected convenience kits with a warning label indicating to remove the affected component and replace it with product from supply. No kits are to returned.", "product_quantity": "516", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K854095", "K903336", "K936117", "K880942", "K931759", "K874439", "K925216", "K934030", "K023276", "K890098", "K924468", "K945481", "K882684", "K880961", "K920267", "K935858", "K913136", "K932217", "K963443", "K953083", "K910365", "K872448", "K905459", "K041080", "K895202", "K934029", "K951478", "K935686", "K212258", "K951149", "K930270", "K934688", "K925467", "K910368", "K923600", "K970187", "K871459", "K961683", "K842648", "K930700", "K871437", "K871434", "K922648", "K964921", "K935740", "K914037", "K934028", "K890658", "K885090", "K945160", "K914036", "K941846", "K971061", "K970286", "K965201", "K931760", "K961863", "K944044", "K971062", "K902888", "K871873", "K890570", "K964011", "K854292", "K881083", "K901856", "K952539", "K933137", "K963721", "K932220", "K925214", "K963715", "K914174", "K950574", "K926269", "K980137", "K931758", "K892389", 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