{ "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": "205096", "product_res_number": "Z-0850-2024", "event_date_initiated": "2023-12-28", "event_date_posted": "2024-02-02", "recall_status": "Open, Classified", "res_event_number": "93676", "product_code": "PNR", "k_numbers": [ "K190502" ], "product_description": "Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit\nConnection System, REF 460SE", "code_info": "UDI/DI 26971564466251 (Case), 16971564466254 (Box), 06971564466257 (Each), Lot Numbers: 230501, 230701 and 230702", "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": "The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.", "root_cause_description": "Process change control", "action": "Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT CORRECTION notice to its consignees on 12/28/2023 via FedEx. The notice explained the problem with the device, risk to patient, and requested the following actions be taken: \n1.\tREVIEW your inventory for the affected product codes and lots. Location of product code and lot are shown in above listed table and below example labeling.\n2.\tCOMMUNICATE with all personnel that utilize the Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) that they should not be used with enteral syringe feeding pumps. \n3.\tPOST a copy of this notification in your storeroom and clinical areas where the product is stored. \n4.\tNOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this medical device product correction and share a copy of this notice.\n5.\tRETURN 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\"\tHospital 800-965-5227\n\"\tDistributor 800-635-6021\n\"\tAll Other Customers 888-444-5440\n\nFor questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at:\nGMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.\n\nA subsequent recall letter dated 2/2/2024 flagged URGENT MEDICAL DEVICE PRODUCT RECALL was issued informing the customer that the recall now involves all sizes of the Cardinal Health brand Monoject sterile Syringe Luer-Lock Soft Packs and Monoject sterile Enteral Syringes with the ENFit connection. This letter supersedes the previous communications. The letter explains the issue, risk to health, and lists the actions that are required. The actions were:\n\n1. REVIEW your inventory for the", "product_quantity": "397676 units", "distribution_pattern": "Distribution US nationwide and Canada.\n\nForeign distribution updated 9/6/2024 to only include Canada.", "openfda": { "k_number": [ "K231300", "K222772", "K161811", "K182649", "K160855", "K252483", "K162188", "K161963", "K190502", "K171857", "K210621", "K161979", "K203613", "K193657", "K170672", "K181426", "K203410", "K152857", "K143344", "K251585", "K253268", "K170371", "K200557", "K183540", "K243652", "K160419", "K202285", "K142128", "K161045", "K211661", "K211025", "K161039", "K211593", "K161141" ], "device_name": "Enteral Syringes With Enteral Specific Connectors", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5980", "device_class": "2", "registration_number": [ "3023228837", "3005670221", "3025432964", "3010331226", "3012421607", "3013298431", "8020785", "1419937", "3009742443", "2029275", "3005674464", "1422634", "3012039263", "3005934752", "3014570560", "3011270181", "9680425", "3005669815", "9612030", "3004099493", "2025917", "3007441619", "1423537", "3007590959", "1423662", "1530671", "1915484", "3004756837", "3008311916", "3014456066", "3006271008", "1217831", "3010131137", "3014656668", "3036722184", "2080225", "3038294399", "3008432385", "3000209995", "3005515211", "3042370483", "1061927", "1017768", "3013557562", "3014662855", "3035455509", "3017509841", "1921846", "3006795797", "3005202235", "3027977504" ], "fei_number": [ "3000203000", "3023228837", "3005670221", "3025432964", "3007596547", "3001236905", "3010331226", "3012421607", "3013298431", "1419937", "3009742443", "3005674464", "3012039263", "3005934752", "3014570560", "1000306431", "3011270181", "3005669815", "3004099493", "2025917", "3007441619", "3007590959", "1915484", "3004756837", "3008311916", "3014456066", "1000514656", "3006271008", "1217831", "3010131137", "3014656668", "3036722184", "2080225", "3038294399", "3008432385", "3000209995", "3001639729", "3000215273", "3005515211", "3042370483", "1017768", "3002806934", "3013557562", "3014662855", "3035455509", "3017509841", "1921846", "3006795797", "3005202235", "3009291251", "3027977504" ] } } ] }