{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "164531", "product_res_number": "Z-2243-2018", "event_date_initiated": "2017-11-10", "event_date_created": "2018-06-15", "recall_status": "Open, Classified", "res_event_number": "80085", "product_code": "EXS", "product_description": "CritiCore Automated Urine Output and Temperature Monitor", "code_info": "DYZIAA003, DYAPAA017, DYARAA002, DYARAA047, DYBPAA012, DYBRAA022, DYBSAA022, DYBSAA067, DYZIAA004, DYAPAA018, DYARAA003, DYARAA048, DYBPAA013, DYBRAA023, DYBSAA023, DYBSAA068, DYZIAA005, DYAPAA019, DYARAA004, DYARAA049, DYBPAA014, DYBRAA024, DYBSAA024, DYBSAA069, DYZIAA006, DYAPAA020, DYARAA005, DYARAA050, DYBPAA015, DYBRAA025, DYBSAA025, DYBSAA070, DYZIAA007, DYAQAA001, DYARAA006, DYARAA051, 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Bard, Inc.", "address_1": "8195 Industrial Blvd NE", "city": "Covington", "state": "GA", "postal_code": "30014-1497", "additional_info_contact": "BMD Customer Service\n800-526-4455 Ext. 5", "reason_for_recall": "Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.", "root_cause_description": "Other", "action": "On Nov 10, 2017 Bard Medical sent notification letter to all their consignees informing them of the following: \nAction required:\n\"Immediately examine your inventory and quarantine product subject to this recall. Please refer to CritiCore MonitorAffected Serial Numbers (Attachment 2) to help you locate the affected product serial number. Do not use or furtherdistribute any affected product.\n\"Please complete and return the accompanying Recall & Effectiveness Check Form (Attachment 1) attached to thisletter regardless of whether you have any of the affected product. Additional instructions for product return arecontained on the form.\n\"If you have further distributed any units with the referenced serial numbers, please identify your customers and notifythem at once of this product recall: Your notification should include a copy of this letter and the accompanying enclosures.\nPlease complete this form by 11/24/2017 and fax to 1-770-784-6469 or email a scanned copy to BMD.FieldAction@crbard.com . If you have affected product, please contact the BMD Customer Service via phone at 1-800-526-4455 option 5 and again option 5 or email BMD.FieldAction@crbard.com to obtain a Return Goods Authorization number (RGA #). Fax this form to 1-770-784-6469 or email a scanned copy to BMD.FieldAction@crbard.com. Attn: Recall Coordinator\nThis recall should be carried out to the user level.", "distribution_pattern": "AR, AZ, CA, FL, GA, HI, IN, JP, KS, LA, MD, MN, MO, MS, NC, NJ, OH, OK, TN, TX, VA, WA, WI, and WY", "openfda": { "device_name": "Urinometer, Electrical", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1800", "device_class": "2", "registration_number": [ "3006082230", "3000126629", "1018233", "3007829657", "3045857305", "9610816", "9611590", "3013041594" ], "fei_number": [ "3002807167", "3006082230", "3000126629", "1000237915", "1018233", "3007829657", "3045857305", "3013041594" ] } } ] }