{ "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": 6 } }, "results": [ { "cfres_id": "219941", "product_res_number": "Z-3114-2026", "event_date_initiated": "2026-06-25", "event_date_posted": "2026-09-04", "recall_status": "Open, Classified", "res_event_number": "98840", "product_code": "EZC", "k_numbers": [ "K910197", "K910846" ], "product_description": "Products that contain the Pericare Wipes:\r\n\r\nBardex Lubricath Foley Catheter Tray\r\nREF:\r\n899914\r\n899916\r\n899918\r\nUDI codes:\r\n00801741024801\t10801741024808\r\n00801741024818\t10801741024815\r\n00801741024825\t10801741024822\r\n\r\nSureStep\" Foley Tray System with Bardex Lubricath Temp Sensing Foley Catheter\r\nREF: A119416M\r\nUDI code: 00801741073700\t10801741073707\r\n\t\r\nSureStep\" Foley Tray System Bard Lubricath Foley\r\nREF: A800361\r\nUDI code: 00801741073939\t10801741073936\r\n\t\r\nSureStep\" Foley Tray System Bard Lubricath Foley Catheter Tray\r\nREF: A899616\r\nUDI code: 00801741104534\t10801741104531\r\n\r\nSureStep\" Foley Tray System Bardex Lubricath Foley Catheter\r\nREF: A899914\r\nUDI code: 00801741074004\t10801741074001\r\n\r\nSureStep\" Foley Tray System Bardex Lubricath Foley Catheter\r\nREF: A899916\r\nUDI code: 00801741074011\t10801741074018\r\n\r\nSureStep\" Foley Tray System Bardex Lubricath Temperature Sensing Catheter\r\nREF: A900216\r\nUDI code: 00801741120978\t10801741120975\r\n\r\nSureStep\" Foley Tray System BardLubricath Foley Catheter\r\nREF:\r\nA902914\r\nA902916\r\nA902918\r\nUDI code:\r\n0080174107406610801741074063\r\n00801741074073\t10801741074070\r\n0080174107408010801741074087\r\n\r\nBard Urine Meter Foley Catheter Tray With Bardex Lubricath Foley Catheter\r\nREF: 304916\r\nUDI code: 00801741019736\t01801741019739\r\n\r\nBard Urine Meter Foley Catheter Tray With Bardex Lubricath Foley Catheter\r\nREF: 902916\r\nUDI codes: 00801741024863\t10801741024860\r\n\r\n(416A) SureStep Foley Tray System Bardex IC Complete Care (714A/716A/718A)SureStep Foley Tray System Bardex IC Complete\r\nREF:\r\nA304914\r\nA304916\r\nA304918\r\nUDI codes: \r\n00801741104350\t10801741104357\r\n00801741104367\t10801741104364\r\n00801741100499\t10801741100496\r\n\r\nSureStep\" Foley Tray System Bard Lubricath Foley\r\nREF: A800365\r\nUDI codes: 00801741073960\t10801741073967\r\n\r\nSureStep\" Foley Tray System Bardex Lubricath Foley Catheter\r\nREF: A899918\r\nUDI codes: 00801741074028\t10801741074025\r\n\r\nSureStep\" Foley Tray System BardLubricath Foley Catheter\r\nREF: A902618\r\nUDI codes: 00801741104640\t10801741104647\r\n\r\nSureStep\" Foley Tray System BardLubricath Foley Catheter\r\nREF: A902616\r\nUDI codes: 00801741104633\t10801741104630\r\n\r\nSureStep Intermittent Catheter Tray\r\nREF: INTL16C\r\nUDI codes: 00801741183195\t10801741183192\r\n\t\r\n\t\r\n\t\r\n\t\r\n\t\r\n\r\n\r\n\r\nFor urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.", "code_info": "Catalog Numbers / UDI codes:\n899914 / 00801741024801¿\t10801741024808\nLot Number: NGKU4611\n\n899916 / 00801741024818¿\t10801741024815\nLot Numbers:\nNGKU2448\nNGKU4610\n\n899918 / 00801741024825¿\t10801741024822\nLot Number: NGKU3555\n\n*****\nSureStep\" Foley Tray System with Bardex¿ Lubricath Temp Sensing Foley Catheter\nREF: A119416M\nUDI code: 00801741073700\t10801741073707\n\t\nSureStep\" Foley Tray System Bard¿ Lubricath Foley\nREF: A800361\nUDI code: 00801741073939\t10801741073936\n\t\nSureStep\" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray\nREF: A899616\nUDI code: 00801741104534¿\t10801741104531\n\nSureStep\" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter\nREF: A899914\nUDI code: 00801741074004\t10801741074001\n\nSureStep\" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter\nREF: A899916\nUDI code: 00801741074011¿\t10801741074018\n\nSureStep\" Foley Tray System Bardex¿ Lubricath¿ Temperature Sensing Catheter\nREF: A900216\nUDI code: 00801741120978¿\t10801741120975\n\nSureStep\" Foley Tray System Bard¿Lubricath¿ Foley Catheter\nREF:\nA902914\nA902916\nA902918\nUDI code:\n00801741074066¿10801741074063\n00801741074073\t10801741074070\n00801741074080¿10801741074087\n\nBard¿ Urine Meter Foley Catheter Tray With Bardex¿ Lubricath¿ Foley Catheter\nREF: 304916\nUDI code: 00801741019736\t01801741019739\n\nBard¿ Urine Meter Foley Catheter Tray With Bardex¿ Lubricath¿ Foley Catheter\nREF: 902916\nUDI codes: 00801741024863\t10801741024860\n\n(416A) SureStep Foley Tray System Bardex IC Complete Care (714A/716A/718A)SureStep Foley Tray System Bardex IC Complete\nREF:\nA304914\nA304916\nA304918\nUDI codes: \n00801741104350¿\t10801741104357\n00801741104367¿\t10801741104364\n00801741100499¿\t10801741100496\n\nSureStep\" Foley Tray System Bard¿ Lubricath Foley\nREF: A800365\nUDI codes: 00801741073960\t10801741073967\n\nSureStep\" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter\nREF: A899918\nUDI codes: 00801741074028\t10801741074025\n\nSureStep\" Foley Tray System Bard¿Lubricath¿ Foley Catheter\nREF: A902618\nUDI codes: 00801741104640\t10801741104647\n\nSureStep\" Foley Tray System Bard¿Lubricath¿ Foley Catheter\nREF: A902616\nUDI codes: 00801741104633¿\t10801741104630\n\nSureStep Intermittent Catheter Tray\nREF: INTL16C\nUDI codes: 00801741183195¿\t10801741183192", "firm_fei_number": "1018233", "recalling_firm": "C.R. Bard Inc", "address_1": "8195 Industrial Blvd Ne", "city": "Covington", "state": "GA", "postal_code": "30014-1497", "additional_info_contact": "770-784-6100", "reason_for_recall": "Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.", "root_cause_description": "Under Investigation by firm", "action": "On 06/25/2026, an \"URGENT Medical Device Recall\" Letter was via regional courier services or other electronic means to inform customers that based on customer feedback, BD has identified that the CliniClean Pericare Wipes provided within Urinary Catheter Trays may be potentially contaminated with an unknown non-biological substance.\n\nCustomer are instructed to:\nDo not use CliniClean Pericare Wipes contained within the affected products listed in Attachment 2. The CliniClean Pericare Wipes are the only impacted component within the tray and all remaining components can continue to be safely used. Users should source alternative, cleansing wipes for the impacted product lots listed in Attachment 2 and ensure they continue to follow their facility protocols for providing perineal care for patients with urinary catheters.\nIf affected CliniClean Pericare Wipes have been used without issue, no additional treatment or clinical follow up is required.\n1. For affected lots, remove and destroy wipes within the product package at the point of use and do not use. Source alternative cleansing wipes for all impacted urinary catheter trays listed in Attachment 2.\n2. Share this notice with any users of the product within your facilities to ensure they are also aware of this Medical Device Correction.\n3. Post this notice in all locations where inventory of these trays are stored.\n4. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the correction notification, whether or not you have any affected product, so that BD may confirm your receipt of this notification.\n\nFor Questions - contact:\nBD Medical Information Services:\nAvailable 24/7 Select #2 when prompted 1-800-555-7422 or Email: medical.information@bd.com\n\nBD Technical Support\n1-844-8BD-LIFE (1-844-823-5433) Say Product Complaint when prompted M-F 8am - 5pm CT or Email: productcomplaints@bd.com", "product_quantity": "12,463 trays/kits", "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WY. The countries of Bahrain, Canada, Costs Rica, Guatemala, Mexico, Saudi Arabia, and United Arab Emirates.", "openfda": { "k_number": [ "K222279", "K910846", "K910195", "K913341", "K910197", "K946282", "K173596" ], "registration_number": [ "3011137372", "1054241", "3003974574", "3013557562", "8040412", "8040607", "1043214", "3013517171", "1423537", "1061124", "3003717263", "3013530345", "3014498861", "3005690789", "3005636544", "2320762", "3004111573", "1055236", "9616088", "9611590", "3011020307", "3006553489", "3010220595", "3006082230", "9614279", "1018233", "3013024191", "3009632672" ], "fei_number": [ "3003974574", "3003040625", "3013557562", "3005747797", "1043214", "3013517171", "1000112968", "1000112877", "3003717263", "1000237915", "3013530345", "3014498861", "3005690789", "3005636544", "3004111573", "3003767881", "3009271244", "3011020307", "3006553489", "3010220595", "3006082230", "3001236905", "3002806591", "1018233", "3013024191", "3009632672", "1000512168", "3002902735" ], "device_name": "Catheter, Coude", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5130", "device_class": "2" } } ] }