{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "215522", "product_res_number": "Z-2528-2025", "event_date_initiated": "2025-07-21", "event_date_posted": "2025-09-05", "recall_status": "Open, Classified", "res_event_number": "97407", "product_code": "LJT", "k_numbers": [ "K130576", "K952435" ], "product_description": "Brand Name: CELSITE\nProduct Name: CELSITE BABYPORT SET PUR 4,5F IV USA\nModel/Catalog Number: 5433742\nSoftware Version: N/A\nProduct Description: CELSITE BABYPORT SET PUR 4,5F IV USA\nComponent: N/A", "code_info": "Model/Catalog Number: 5433742; \nPrimary-DI 04046963594947; \nLot 37041185; \nExp 19MAR2030;", "firm_fei_number": "3002806713", "recalling_firm": "B.Braun Medical S.A.S.", "address_1": "30 celsa lg medical avenue des temps", "city": "Chasseneuil du Poitou CEDEX Cs", "postal_code": "10031", "country": "France", "additional_info_contact": "Allison Longenhagen\n001-484-2408373", "reason_for_recall": "The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.", "root_cause_description": "Under Investigation by firm", "action": "On July 21, 2025 URGENT - FIELD SAFETY NOTICE - PRODUCT RECALL letters were sent to customers. Actions to be taken: Check whether you have the above-mentioned product in stock, and quarantine it. Confirm the receipt of this Field Safety Notice on the enclosed confirmation form. Additionally record on the enclosed confirmation form the received amount of potentially affected products with the above-mentioned batch number(s) as well as the amount used and the amount to be returned. Even if you don't have any inventory, please return the completed and signed confirmation form\nin a timely manner to the fax number or e-mail address given on the form. Return the quarantined product to the following address with a copy of the enclosed confirmation form. Please retain this Field Safety Notice until you have completed all the above measures. Please make sure that all users of the above-mentioned products in your organization and other concerned persons are informed about this Field Safety Corrective Action. If you have forwarded the products to a third party, please forward a copy of the Field Safety Notice to them or inform the contact person provided. We sincerely apologize for any inconvenience this recall may cause. To compensate for the recalled product(s), a replacement or a credit note. Please contact our dedicated customer service team to arrange for compensation.", "product_quantity": "58 units", "distribution_pattern": "US Nationwide distribution in the state of PA.", "openfda": { "k_number": [ "K060812", "K992697", "K993024", "K882230", "K890518", "K122402", "K181446", "K021580", "K872329", "K945752", "K840788", "K252478", "K961580", "K880571", "K081472", "K951875", "K000125", "K063377", "K953073", "K953110", "K921902", "K081889", "K962230", "K903364", "K853827", "K875213", "K003006", "K070911", "K830000", "K880297", "K926139", "K932509", "K934504", "K934796", "K936012", "K903220", "K072481", "K841150", "K955819", "K994111", "K905646", "K951077", "K905839", "K032754", "K891611", "K905851", "K894650", "K924250", "K905838", "K131694", "K873213", "K870187", "K953017", "K870950", "K031282", "K150514", "K260916", "K912540", "K010767", "K871192", "K964117", "K905842", "K951814", "K870260", "K921475", "K971582", "K934573", "K924505", "K022110", "K933990", "K954433", "K933316", "K120281", "K951872", "K934167", "K091099", "K853332", "K232737", "K913350", "K061424", "K910005", "K905840", "K922896", "K960350", "K951076", "K893460", "K933350", "K870817", "K251253", "K982888", "K932095", "K022983", "K905845", "K863296", "K870519", "K141146", "K942784", "K994216", "K954297", "K922147", "K973862", "K062414", "K002770", "K974533", "K874184", "K963684", "K871209", "K895871", "K942412", "K912702", "K073423", "K905847", "K032557", "K954258", "K875276", "K060036", "K032375", "K961615", "K881342", "K032600", "K101017", "K931748", "K133335", "K945250", "K925373", "K032044", "K911355", "K150733", "K955407", "K926011", "K030083", "K832917", "K050176", "K991897", "K982507", "K905844", "K912424", "K905849", "K130576", "K992880", "K034065", "K112713", "K942103", "K994196", "K153238", "K093414", "K911055", "K072657", "K140169", "K102385", "K830730", "K964066", "K854019", "K903691", "K952748", "K043178", "K032008", "K905841", "K932841", "K895689", "K153228", "K881256", "K030636", "K073210", "K971140", "K932010", "K862018", "K953529", "K082126", "K905848", "K070003", "K882190", "K841149", "K881745", "K934518", "K861498", "K924748", "K895030", "K935767", "K080645", "K945551", "K050310", "K905852", "K964559", "K922419", "K873575", "K130923", "K896093", "K921201", "K864446", "K930206", "K993860", "K946189", "K942024", "K932411", "K973497", "K932840", "K904077", "K905843", "K942848", "K864349", "K964538", "K081311", "K955587", "K111101", "K961583", "K921379", "K953254", "K841679", "K110407", "K842355", "K901419", "K872838", "K932671", "K934802", "K960572", "K961652", "K974475", "K974471", "K950131", "K911449", "K932447", "K950212", "K823838", "K934640", "K242328", "K853981", "K952435", "K912423", "K132177", "K010426", "K923019", "K872149", "K851293", "K951873", "K033686", "K031844", "K122767", "K881075", "K951874", "K071993", "K190559", "K090512", "K850888", "K863723", "K010189", "K904417", "K910448", "K880305", "K863750", "K873735", "K933986", "K912465", "K962751", "K952537", "K122899", "K970442", "K983480", "K934792", "K952548", "K942623", "K953571", "K962695", "K901722", "K870886", "K915273", "K153359", "K832788", "K875214", "K905846", "K872898", "K863305", "K033473", "K850967", "K922434", "K151239", "K081425", "K934520", "K122834", "K070116", "K072215", "K853322", "K072549", "K920036", "K905850", "K974829", "K110424", "K840481" ], "registration_number": [ "1000393132", "3010149039", "1319211", "1319639", "3011534620", "3003678543", "2518902", "2011171", "3015537049", "1820334", "9617592", "3012494290", "3006260740", "3011088743", "3004407880", "3005232773", "3007939342", "2032112", "2246552", "3013666218", "3006942524", "9611665", "3010041511", "3005704822", "3006425876", "3003700453", "9612452", "3013750125", "3014579161", "1061124", "1223004", "3042205359", "3009888344", "1000523114", "3007156625", "1220905", "1219930", "3026560514", "9617604", "8020785", "3047514279", "3013557562", "3008537309", "3018094310", "1018233", "3003915875", "2030624", "9681202", "2245270", "1048735", "3011237770", "9680794", "3006082230", "2025816", "3009746061", "3015859709", "1450392", "1222928", "3015531529" ], "fei_number": [ "1000393132", "3010149039", "1319211", "1000138054", "3011534620", "3003678543", "2518902", "2011171", "3015537049", "3009291251", "1820334", "3006260740", "3012494290", "3000206435", "3011088743", "3004407880", "3005232773", "3007939342", "2246552", "3013666218", "3008737795", "1000120613", "3002468371", "3006942524", "3002558692", "3010041511", "3005704822", "3006425876", "3003700453", "3003076831", "3013750125", "3014579161", "3042205359", "3009888344", "1000120555", "1000523114", "1000512168", "1220905", "1219930", "3026560514", "3002807095", "3002806713", "3047514279", "3013557562", "3008133910", "3008537309", "3018094310", "1018233", "3003915875", "1048735", "2245270", "3006082230", "3011237770", "3003737899", "2025816", "3009746061", "3015859709", "1450392", "3015531529" ], "device_name": "Port & Catheter, Implanted, Subcutaneous, Intravascular", "medical_specialty_description": "General Hospital", "regulation_number": "880.5965", "device_class": "2" } } ] }