{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196695", "product_res_number": "Z-0356-2023", "event_date_initiated": "2022-11-01", "event_date_posted": "2022-12-02", "recall_status": "Open, Classified", "res_event_number": "91087", "product_code": "FCM", "k_numbers": [ "K903340" ], "product_description": "Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter\nProduct Code: 2480\t\nIntended for urinary drainage from the bladder of a patient", "code_info": "UDI-DI: \nEach\t10884521009370\t\nCase\t20884521009377\n\nLot Numbers: \t2216501464, 2213046064, 2206726764", "firm_fei_number": "3014524790", "recalling_firm": "Cardinal Health", "address_1": "777 West St", "city": "Mansfield", "state": "MA", "postal_code": "02048-1122", "additional_info_contact": "Todd King\n847-596-3785", "reason_for_recall": "Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention", "root_cause_description": "Equipment maintenance", "action": "Cardinal Health issued Urgent Medical Device Recall Letter (Event-2022-04944) and Acknowledgement Form on November 1, 2022 to the direct consignees. Letter states reason for recall, health risk and action to take:\nActions Required:\t\n1.\tREVIEW your inventory for the affected product codes and lots. Location of product codes and lots are shown in Attachment 1.\n2.\tSEGREGATE and quarantine all affected product upon review of your inventory. \n3.\tNOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this product recall notice and share a copy of this notice.\n4.\tRETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to GMB-FieldCorrectiveAction@cardinalhealth.com, whether you have affected product.\nCONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5pm EST:\n\"\tHospital 800-965-5227\n\"\tFederal Government 800-444-1166\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.", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K771651", "K780124", "K254076", "K780268", "K962073", "K223821", "K082831", "K011055", "K896212", "K960214", "K771104", "K903340", "K760127", "K070048", "K003873", "K962254", "K901180", "K760048", "K790272", "K250891", "K901181", "K963993", "K901185", "K780879", "K790254", "K901183", "K960215", "K910022", "K772277", "K910653", "K923538", "K772340", "K070939", "K950109", "K951479", "K771103", "K771652", "K760128", "K950390", "K010420", "K790271", "K904158", "K030712", "K950344", "K961442", "K030664", "K780735", "K901184", "K960566", "K771650", "K770496", "K780123", "K950092", "K002803", "K942177", "K951178", "K772341", "K772342", "K983010", "K902508" ], "device_name": "Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5130", "device_class": "2", "registration_number": [ "3004727093", "1423537", "3012445205", "3012494290", "9610849", "3008806809", "9610694", "3005012805", "3014656749", "1420054", "3011707784", "3015176887", "2011171", "3014404707", "3043226252", "2648727", "2320961", "3008191244", "3011987967", "3005669815", "9611590", "1055236", "1043214", "3011137372", "1921846", "3014421917", "3006430057", "3006673317", "3013188547", "1054241", "1480288", "3015173212", "3018116884", "2032112", "1018233", "3022518300", "3004122598", "3010220595", "9612030", "3015142802", "2029015", "1647149", "2320762", "3002993863", "8040412", "3006542380", "3006082230", "3004365956", "3030087693", "3009609358", "3045816902", "3017961114", "8040607", "1928237", "1650927", "3007185216", "3004111573", "3017937889", "9680787" ], "fei_number": [ "3005596530", "3004727093", "3012445205", "1000306139", "3002807391", "3002806731", "3012494290", "3003076831", "3008806809", "3005012805", "1000160458", "3014656749", "1420054", "3002826093", "3011707784", "3015176887", "2011171", "3014404707", "3043226252", "2648727", "3008191244", "3001236905", "3011987967", "3005669815", "3009271244", "1043214", "1921846", "3014421917", "3006430057", "3002806591", "1000112968", "3013188547", "1480288", "3015173212", "3018116884", "1018233", "3022518300", "3004122598", "3003040625", "3002695476", "3010220595", "3015142802", "3002993863", "1000237915", "3003172243", "3005747797", "3006542380", "3002806934", "3004365956", "3030087693", "3006082230", "1000112877", "3009609358", "3045816902", "3017961114", "1928237", "3007185216", "3004111573", "3017937889" ] } } ] }