{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210364", "product_res_number": "Z-0310-2025", "event_date_initiated": "2024-09-25", "event_date_posted": "2024-11-08", "recall_status": "Open, Classified", "res_event_number": "95487", "product_code": "MEG", "product_description": "Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777", "code_info": "UDI/DI 10192253034783 (EA), Lot Number 221201, exp. 2027-11-30; UDI/DI 20192253034780 (BX), Lot Number 230201, exp. 2028-01-31; UDI/DI 50192253034781 (CS), Lot Number 230202,exp. 2028-02-01", "firm_fei_number": "3001236905", "recalling_firm": "Cardinal Health 200, LLC", "address_1": "3651 Birchwood Dr", "city": "Waukegan", "state": "IL", "postal_code": "60085-8337", "additional_info_contact": "847-887-5500", "reason_for_recall": "Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.", "root_cause_description": "Under Investigation by firm", "action": "Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL to its consignees on 09/25/2024 via overnight mail. The notice explained the issue, risk to health, and requested the following actions: \n1. REVIEW inventory for the affected product code and lots.\n2. COMMUNICATE with all personnel who utilize the Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack that it should not be used for administration of IV push insulin via needleless connector.\n3. POST a copy of this notification in your storeroom where the product is stored.\n4. NOTIFY any customers to whom you may have distributed/forwarded affected product or to whom you plan to send the product about this medical device product correction and share a copy of this notice.\n5. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to GMB-FieldCorrectiveAction@cardinalhealth.com, whether you have affected product or not. \nCONTACT the appropriate Customer Service group with questions related to this notification. Monday Friday between 8:00am - 5pm EST:\n\" Hospital 800-964-5227\n\" Federal Government 800-444-1166\n\" Distributor 800-635-6021\n\" All Other Customers 888-444-5440", "product_quantity": "371,326 units", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K101233", "K072037", "K223376", "K060971", "K012726", "K012121", "K103781", "K202570", "K212949", "K000860", "K060772", "K141349", "K032780", "K193022", "K971077", "K933569", "K060668", "K010819", "K030604", "K052103", "K980069", "K150562", "K052397", "K210216", "K221981", "K993996", "K141464", "K101560", "K220061", "K210229", "K011369", "K123743", "K042426", "K173743", "K072739", "K032517", "K050134", "K936225", "K013006", "K970803", "K062780", "K944425", "K080600", "K211555", "K936040", "K042102", "K211329", "K003348", "K925039", "K001017", "K050131", "K031909", "K042712", "K060208", "K231165", "K141664", "K024249", "K212652", "K043419", "K003555", "K010477", "K092430", "K023323", "K132681", "K112936", "K031062", 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