{ "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": "210779", "product_res_number": "Z-0508-2025", "event_date_initiated": "2024-10-16", "event_date_posted": "2024-11-22", "recall_status": "Open, Classified", "res_event_number": "95615", "product_code": "CAZ", "k_numbers": [ "K051171" ], "product_description": "MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector", "code_info": "UDI/DI 10193489490312 (each), 40193489490313 (case), Lot Numbers: 21ABD173, 21EBC720, 21GBG632, 21HBF316, 21IBH392, 21IBM516, 21JBJ902, 21JBP187, 22IBL115, 22KBD213, 22OBI434, 23ABA553, 23ABO991, 23BBG757, 23CBO551, 23EBT535", "firm_fei_number": "1417592", "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Haley Barclay\n866-359-1704", "reason_for_recall": "The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.", "root_cause_description": "Under Investigation by firm", "action": "An IMMEDIATE ACTION REQUIRED RECALL notification letter dated 10/16/24 was sent to customers.\n\nREQUIRED ACTION:\n1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately.\n2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form.\n3.Upon receipt of your submitted response form, your account will receive over-labels to place unaffected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.comRecall Reference #: R-24-216-FGRecall Code: \n4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication.\n\nIf you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.", "product_quantity": "1975 units", "distribution_pattern": "US Nationwide. 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