{ "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": "216888", "product_res_number": "Z-0645-2026", "event_date_initiated": "2025-10-29", "event_date_posted": "2025-11-26", "recall_status": "Open, Classified", "res_event_number": "97816", "product_code": "FMG", "k_numbers": [ "K060231" ], "product_description": "IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number:\n\n1. IV SET 15DR 5CARESITE 1 ULRAPORT, 141 IN; Catalog Number: 490067.", "code_info": "1. Catalog Number: 490067; Primary UDI-DI: 04046964186042; Unit of Dose UDI-DI: 04046964186035.", "firm_fei_number": "2521402", "recalling_firm": "B Braun Medical Inc", "address_1": "824 12th Ave", "city": "Bethlehem", "state": "PA", "postal_code": "18018-3524", "additional_info_contact": "Allison Longenhagen\n001-484-2408373", "reason_for_recall": "Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).", "root_cause_description": "Process control", "action": "B Braun notified consignees on about 10/29/2025 via letter. Consignees were instructed to follow \"Interim Measures for Users\" as outlined in the letter for secondary infusions via gravity sets and if using secondary infusions with infusion pumps. \n\nConsignees were also instructed to inform all users and post the applicable attachment(s) in care areas where secondary infusions may be administered and where IV administration sets and pump administration sets may be stored until further notice. B. Braun will provide additional notification when users may resume their normal secondary administration process without the need for the modified workflow. Consider priming all IV administration sets and pump administration sets with normal saline or other standard solutions prior to priming with expensive medications to avoid loss of expensive medications or occupational exposure to hazardous medications in the event the set is unable to be primed. If difficulty priming is encountered, obtain a replacement device and file a customer complaint with B. Braun.\n\nAdditionally, consignees were requested to ensure all pertinent employees and customers are informed, post the notification where affected products are stored, and complete and return the \"Urgent Medical Device Correction Acknowledgement Form.\"", "product_quantity": "407,800 units", "distribution_pattern": "Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.", "openfda": { "k_number": [ "K800862", "K052330", "K760678", "K932512", "K041779", "K790010", "K022895", "K792126", "K810375", "K853275", "K884435", "K823120", "K061143", "K940070", "K760666", "K082836", "K800863", "K851986", "K760679", "K771911", "K872067", "K864900", "K884463", "K954984", "K820165", "K242255", "K800864", "K010217", "K812927", "K842173", "K760667", "K770707", "K881805", "K782167", "K961982", "K082106", "K053405", "K962581", "K223175", "K854348", "K891234", "K870261", "K954970", "K211204", "K840394", "K792128", "K012157", "K862691", "K071400", "K800284", "K792124", "K782168", "K080077", "K982368", "K770708", "K974083", "K860889", "K780662", "K830198", "K870324", "K060231", "K964435", "K792127", "K911415", "K913560", "K210516", "K953573", "K130245", "K955782", "K792125", "K862492", "K823469", "K223499", "K850280", "K123084", "K172266", "K902724", "K872066", "K190489", "K070143", "K082110", "K190539", "K141254", "K823373", "K864440", "K802258", "K770916", "K032393", "K780596" ], "registration_number": [ "3010432890", "1060680", "1649914", "3020778", "3006891665", "2029275", "1416980", "1423507", "3007017524", "1713468", "1047429", "1423662", "1047843", "2025816", "1000563940", "3006950086", "3012261967", "9610849", "1625425", "3007344957", "3015276780", "1223004", "9612052", "2011171", "3012798826", "1644312", "2032112", "2245270", "3004111573", "3003704957", "3015309643", "2523676", "3007738736", "9616088", "2024024", "1220477", "1018470", "3010041511", "1518293", "3017636737", "3005941719", "9610847", "3013517171", "9615817", "3045322464", "3010421104", "3009211636", "8020616", "3006475220", "9612152", "3002907620", "3012809732", "3032916632", "1423537", "1043214", "8040700", "9617594", "1424263", "3015173212", "1061124", "3013557562", "9614279", "3030447506", "2243072", "3013188547", "1055236", "2032098", "3033589330", "3012536737", "3015085713", "3013683058", "1030451", "1526863", "9616567", "3013764800", "2022435", "9613418", "1928237", "1319639", "3035642068", "3033536319", "9680794", "1054241", "3005012805", "2320762", "3006425876", "3012410077" ], "fei_number": [ "3010432890", "1000138054", "3002902735", "3020778", "3001236905", "3006891665", "1416980", "1000208624", "3007017524", "1713468", "1047429", "3003040625", "1047843", "2025816", "3002807391", "1000563940", "3006950086", "3012261967", "3002807111", "1625425", "3007344957", "3015276780", "3002879021", "2011171", "3003076831", "3012798826", "1000120555", "2245270", "1000306431", "3003081151", "3002806588", "3004111573", "3003704957", "3015309643", "2523676", "3007738736", "3001044237", "2024024", "1220477", "1018470", "3010041511", "3003058448", "3002806476", "1518293", "3017636737", "3008002452", "3013517171", "3045322464", "3010421104", "3009211636", "3001665800", "3006475220", "3002907620", "3012809732", "3032916632", "3002806443", "1043214", "1000112968", "3002963732", "3003737899", "1000512168", "3000215273", "3015173212", "3013557562", "3030447506", "2243072", "1000117748", "3013188547", "1000112877", "3002806901", "3033589330", "3012536737", "3015085713", "3013683058", "1030451", "1526863", "3013764800", "2022435", "3003015552", "1928237", "3003767881", "3035642068", "3033536319", "3005012805", "3006425876", "3003807466", "3012410077" ], "device_name": "Stopcock, I.V. Set", "medical_specialty_description": "General Hospital", "regulation_number": "880.5440", "device_class": "2" } } ] }