{ "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": "26681", "product_res_number": "Z-0732-03", "event_date_initiated": "2003-03-25", "event_date_posted": "2003-04-17", "recall_status": "Terminated", "event_date_terminated": "2003-08-07", "res_event_number": "25894", "product_code": "FAQ", "k_numbers": [ "K780032" ], "product_description": "Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, C.R.Bard, Inc., Covington, GA 30014, Contents Sterile.", "code_info": "Catalogue #150719, 150732, 150819, 150832, Lot numbers beginning with 76JL through 76BN.", "firm_fei_number": "1018233", "recalling_firm": "C.R. Bard, Inc., Urological Division", "address_1": "8195 Industrial Blvd NE", "city": "Covington", "state": "GA", "postal_code": "30014", "additional_info_contact": "Frances E. Harrison\n770-784-6257", "reason_for_recall": "There is a potential for package seals to be open after sterilization.", "root_cause_description": "Other", "action": "The oldest lot that the firm has confirmed in inventory that had an open seal was manufactured in October 2002. Based upon depletion analysis with distributor inventory being three months and an additional assurance of 12 months, the firm is removing product manufactured from October 1, 2001 through February 28, 2003. Consignees were notified via certified letter with Business Reply Form attached for effectiveness check. Consignees were advised to remove/segregate, and return affected product for credit.", "product_quantity": "283, 277 units", "distribution_pattern": "Product was distributed to 16 doctors, 79 hospitals, 280 distributors, and 53 sales representatives nationwide.", "openfda": { "k_number": [ "K896129", "K960217", "K780190", "K896728", "K951945", "K780032", "K934052", "K945204", "K926035", "K901219", "K955609", "K953783", "K962604", "K903611", "K924406", "K772402", "K931727", "K953767" ], "registration_number": [ "3010595915", "3009104075", "3026331889", "3007407626", "3011020307", "3011529314", "1417592", "3014615175", "3007007790", "3014498861", "3015479927", "1043646", "3010806410", "3030896267", "3005327291", "9610694", "3007703293", "3034629649", "3027315856", "2320961", "3014637079", "3003824562", "3010700223", "3010273861", "3034669683", "3031184338", "3006673317", "3016758972", "3019798849", "3016426851", "3013530901", "2011171", "3015859108", "3009746061", "3015625160", "3013513837", "1644312", "3012104670", "3014159736", "2648727", "1519375", "3004111573", "3010198795", "3003561450", "3004365956", "3012050423", "3014437893", "3018781093", "3005621808", "3016452400", "3013473968", "3008262278", "3008573567", "1921846", "2023344", "9710020", "3013517171", "3006061749", "3008496560", "9616991", "3015997711", "3001124136", "3005273623", "8040459", "3018503755", "9616083", "3005669815", "3010621964", "3013443304", "3045058049", "1423537", "1836161", "3013522936", "3016884191", "3010305275", "3010131137", "3010339057", "3013187142", "3015142802", "1480288", "8021995", "9611590", "3007092328", "3031190571", "1061124", "3013557562", "1058397", "3010280735", "3005271071", "9611024", "9680934", "3033796870", "3008502431", "1018233", "3017896419", "3015176887", "3003965134", "3009349165", "3025443432", "1420054", "3011814545", "3042970965", "3006210673", "3006405073", "3006082230", "3000268902", "9613418", "3008191244", "1928237", "3006897996", "3042244574", "3002807090", "3015058854", "3010407203", "3005945907", "3011137372", "3031582449", "3014195785", "3011191255", "3003814961", "3016171914", "9681338" ], "fei_number": [ "3010595915", "3009104075", "3005747797", "3026331889", "3007407626", "3011020307", "3001236905", "3011529314", "1417592", "3014615175", "3007007790", "3014498861", "3015479927", "1043646", "3010806410", "3005596530", "3003205539", "3030896267", "3005327291", "3007703293", "3034629649", "3027315856", "3003172243", "3014637079", "3003824562", "3010700223", "3010273861", "3002807170", "3034669683", "3031184338", "3016758972", "3019798849", "3016426851", "3013530901", "2011171", "3015859108", "3009746061", "3002750084", "3015625160", "3013513837", "3012104670", "3014159736", "1000158532", "2648727", "1519375", "3004111573", "3010198795", "3003561450", "3004365956", "3003340795", "3012050423", "3014437893", "3018781093", "3001044237", "3005621808", "3016452400", "3013473968", "6612", "3008262278", "3008573567", "1921846", "2023344", "3013517171", "3006061749", "3008496560", "3015997711", "3001124136", "3005273623", "3018503755", "3005669815", "3010621964", "3013443304", "3045058049", "3013522936", "3016884191", "3010305275", "3010131137", "3010339057", "3006003617", "1000512168", "3013187142", "3015142802", "1480288", "3007092328", "3031190571", "3006993165", "3002806731", "3013557562", "3010280735", "3005271071", "1000237915", "3033796870", "3008502431", "1000117748", "1018233", "3017896419", "3015176887", "3003965134", "3006363476", "3009349165", "3025443432", "1420054", "3011814545", "3042970965", "3006210673", "3006405073", "3006082230", "3003123739", "3000268902", "3008191244", "1928237", "3006897996", "3042244574", "3015058854", "3010407203", "3005945907", "3031582449", "3014195785", "3011191255", "3003814961", "3016171914", "1000612470" ], "device_name": "Bag, Urine Collection, Leg, For External Use, Sterile", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5250", "device_class": "1" } } ] }