{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216916", "product_res_number": "Z-0670-2026", "event_date_initiated": "2025-10-29", "event_date_posted": "2025-11-26", "recall_status": "Open, Classified", "res_event_number": "97816", "product_code": "FPA", "k_numbers": [ "K170595" ], "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 ADMIN SET 15 DR W/2 SAFEDAY; Catalog Number: 352636. \n\n2. IV ADMIN SET 15 DR W/2 SAFEDAY 84 IN.; Catalog Number: 352639. \n\n3. IV ADMIN SET 15 DROP W/3 SAFEDAY; Catalog Number: 352640. \n\n4.\tIV ADMIN 15D W/2 SAFEDAY & 0.2 FILTER; Catalog Number: 352643. \n\n5.\tIV ADMIN SET, 105 IN.; Catalog Number: 477003. \n\n6.\tIV ADMIN SET 15D, 4 CARESTIE LAD, 145 IN; Catalog Number: 477006. \n\n7.\tIV ADMIN SET, 121 IN.; Catalog Number: 477008. \n\n8.\tIV ADMIN SET 15D, CARESTIE LAD, 90 IN; Catalog Number: 477012. \n\n9.\tIV ADMIN SET, 2 CARESTIE LAD, 15D, 117IN; Catalog Number: 477019. \n\n10.\tIV ADMIN SET, 15D, 5CARESITE LAD, 136 IN; Catalog Number: 477021. \n\n11.\tIV ADMIN SET 114 IN.; Catalog Number: 477022. \n\n12.\tIV ADMIN SET 5 CARESITE LADS, 126 IN.; Catalog Number: 477023. \n\n13.\tIV SET 15DR 3 SAFEDAY, 106 IN.; Catalog Number: 477053. \n\n14.\tIV ADMIN SET, 15DR, CARESITE LAD, 121 IN; Catalog Number: 490513. \n\n15.\tIV ADMIN SET, 15D, 120 IN.; Catalog Number: 490521. \n\n16.\tIV ADMIN SET 15D 2 CARESITE LADS, 112IN.; Catalog Number: 490527. \n\n17.\tIV ADMIN SET 15 DRP CARESITE SAFEPORT; Catalog Number: 490529. \n\n18.\tIV ADMIN SET, 15D, 139 IN.; Catalog Number: 490535. \n\n19.\tIV ADMIN SET 15D, CARESITE LAD, 122IN.; Catalog Number: 490543. \n\n20.\tIV ADMIN SET 15D 3 CARESITE LADS, 150IN.; Catalog Number: 490546. \n\n21.\tIV ADMIN SET, 125 IN.; Catalog Number: 490547. \n\n22.\tIV ADMIN SET 15D, 5 CARESITE INJ, 150in.; Catalog Number: 490552. \n\n23.\tIV ADMIN SET, 120IN.; Catalog Number: 490553. \n\n24.\tIV ADMIN SETW/ B/C VLV 3 CARESITE 134IN.; Catalog Number: 490554. \n\n25.\tIV ADMIN SET 15DR w/3 B/C VLV, 124 IN.; Catalog Number: 490555. \n\n26.\tIV ADMIN SET 15D w/B/C VLV, 139 IN.; Catalog Number: 490558. \n\n27.\tIV ADMINISTRATION SET, 117 IN.; Catalog Number: 490559. \n\n28.\tIV ADMINISTRATION SET, 108 IN.; Catalog Number: 490560. \n\n29.\tIV ADMINISTRATION SET, 134 IN.; Catalog Number: 490561. \n\n30.\tIV ADMIN SET 15D w/B/C VLV, 140 IN.; Catalog Number: 490562. \n\n31.\tIV ADMIN SET, 111 IN.; Catalog Number: 490563. \n\n32.\tIV ADMIN SET 15D 2 CARESITE LADS, 122 IN; Catalog Number: 490569. \n\n33.\tIV ADMIN SET 15D STOPCOCK, DUAL MANIFOLD; Catalog Number: 490573. \n\n34.\tIV ADMIN SET 15D w/B/C VLV, 110 IN.; Catalog Number: 490574. \n\n35.\tIV ADMIN 15D 5 CARESITE LADS STPCK 120in; Catalog Number: 490575. \n\n36.\tIV ADMIN SET 15D 5 CARESITE LADS, 140 IN; Catalog Number: 490578. \n\n37.\tIV ADMIN SET W/15D, 4 CARESITE LADS; Catalog Number: 490581. \n\n38.\tIV ADMIN 15D CARESITE LADS, STPCK 134 IN; Catalog Number: 490582. \n\n39.\tIV ADMIN SET, 15D, 108 IN.; Catalog Number: 490583. \n\n40.\tIV ADMIN SET, 10 DROP, 130 IN.; Catalog Number: 490588. \n\n41.\tIV ADMIN SET, 132 IN.; Catalog Number: 490589. \n\n42.\tIV ADMIN SET, 15DR, 105 IN.; Catalog Number: 490600. \n\n43.\tIV ADMIN SET,3 CARESITE,3 HF SPCK, 129IN; Catalog Number: 490607. \n\n44.\tIV SET 15DR 3CARESITE 2STOPCOCK, 126IN; Catalog Number: 490608. \n\n45.\tIV ADMIN SET 15D 2 CARESITE LADS, 138 IN; Catalog Number: 490615. \n\n46.\tIV SET 15DR 2SAFEDAY 2SAFEPORT, 99 IN.; Catalog Number: 490618. \n\n47.\tIV SET 60DR 2SAFEDAY 2SAFEPORT, 99 IN.; Catalog Number: 490619. \n\n48.\tIV ADMIN SET 15 DRPS 4W STOPCOCK W/ C&S; Catalog Number: 490644. \n\n49.\tIV ADMIN SET 15 DRPS ULTRAP. ZERO 90.6IN; Catalog Number: 490657. \n\n50.\tIV ADMIN SET 15 DRPS STOPCOCK MALE 117IN; Catalog Number: 490658.", "code_info": "1.\tCatalog Number: 352636; Primary UDI-DI: 04046955594597; Unit of Dose UDI-DI: 04046955594580; Expiration Date: 36mths from Start Date. \n\n2.\tCatalog Number: 352639; Primary UDI-DI: 04046955594672; Unit of Dose UDI-DI: 04046955594665; Expiration Date: 36mths from Start Date. \n\n3.\tCatalog Number: 352640; Primary UDI-DI: 04046955594696; Unit of Dose UDI-DI: 04046955594689; Expiration Date: 36mths from Start Date. \n\n4.\tCatalog Number: 352643; Primary UDI-DI: 04046955594757; Unit of Dose UDI-DI: 04046955594740; Expiration Date: 36mths from Start Date. \n\n5.\tCatalog Number: 477003; Primary UDI-DI: 04046955202836; Unit of Dose UDI-DI: 04046955202829; Expiration Date: Earliest Exp of Comp or 36mths. \n\n6.\tCatalog Number: 477006; Primary UDI-DI: 04046955202751; Unit of Dose UDI-DI: 04046955202744; Expiration Date: Earliest Exp of Comp or 36mths. \n\n7.\tCatalog Number: 477008; Primary UDI-DI: 04046955202850; Unit of Dose UDI-DI: 04046955202843; Expiration Date: Earliest Exp of Comp or 36mths. \n\n8.\tCatalog Number: 477012; Primary UDI-DI: 04046955202874; Unit of Dose UDI-DI: 04046955202867; Expiration Date: Earliest Exp of Comp or 36mths. \n\n9.\tCatalog Number: 477019; Primary UDI-DI: 04046955203147; Unit of Dose UDI-DI: 04046955203130; Expiration Date: Earliest Exp of Comp or 36mths. \n\n10.\tCatalog Number: 477021; Primary UDI-DI: 04046955269983; Unit of Dose UDI-DI: 04046955269976; Expiration Date: Earliest Exp of Comp or 36mths. \n\n11.\tCatalog Number: 477022; Primary UDI-DI: 04046955270002; Unit of Dose UDI-DI: 04046955269990; Expiration Date: Earliest Exp of Comp or 36mths. \n\n12.\tCatalog Number: 477023; Primary UDI-DI: 04046955270026; Unit of Dose UDI-DI: 04046955270019; Expiration Date: Earliest Exp of Comp or 36mths. \n\n13.\tCatalog Number: 477053; Primary UDI-DI: 04046955672431; Unit of Dose UDI-DI: 04046955672424; Expiration Date: Earliest Exp of Comp or 36mths. \n\n14.\tCatalog Number: 490513; Primary UDI-DI: 04046955137237; Unit of Dose UDI-DI: 04046955137220; Expiration Date: Earliest Exp of Comp or 36mths. \n\n15.\tCatalog Number: 490521; Primary UDI-DI: 04046955185252; Unit of Dose UDI-DI: 04046955186563; Expiration Date: Earliest Exp of Comp or 24mths. \n\n16.\tCatalog Number: 490527; Primary UDI-DI: 04046955203222; Unit of Dose UDI-DI: 04046955203215; Expiration Date: Earliest Exp of Comp or 36mths. \n\n17.\tCatalog Number: 490529; Primary UDI-DI: 04046955203307; Unit of Dose UDI-DI: 04046955203291; Expiration Date: Earliest Exp of Comp or 24mths. \n\n18.\tCatalog Number: 490535; Primary UDI-DI: 04046955203406; Unit of Dose UDI-DI: 04046955203390; Expiration Date: Earliest Exp of Comp or 36mths. \n\n19.\tCatalog Number: 490543; Primary UDI-DI: 04046955270200; Unit of Dose UDI-DI: 04046955270194; Expiration Date: Earliest Exp of Comp or 36mths. \n\n20.\tCatalog Number: 490546; Primary UDI-DI: 04046955270262; Unit of Dose UDI-DI: 04046955270255; Expiration Date: Earliest Exp of Comp or 36mths. \n\n21.\tCatalog Number: 490547; Primary UDI-DI: 04046955270286; Unit of Dose UDI-DI: 04046955270279; Expiration Date: Earliest Exp of Comp or 36mths. \n\n22.\tCatalog Number: 490552; Primary UDI-DI: 04046955275342; Unit of Dose UDI-DI: 04046955275335; Expiration Date: Earliest Exp of Comp or 36mths. \n\n23.\tCatalog Number: 490553; Primary UDI-DI: 04046955275366; Unit of Dose UDI-DI: 04046955275359; Expiration Date: Earliest Exp of Comp or 36mths. \n\n24.\tCatalog Number: 490554; Primary UDI-DI: 04046955275380; Unit of Dose UDI-DI: 04046955275373; Expiration Date: Earliest Exp of Comp or 36mths. \n\n25.\tCatalog Number: 490555; Primary UDI-DI: 04046955275403; Unit of Dose UDI-DI: 04046955275397; Expiration Date: Earliest Exp of Comp or 36mths. \n\n26.\tCatalog Number: 490558; Primary UDI-DI: 04046955275465; Unit of Dose UDI-DI: 04046955275458; Expiration Date: Earliest Exp of Comp or 36mths. \n\n27.\tCatalog Number: 490559; Primary UDI-DI: 04046955275489; Unit of Dose UDI-DI: 04046955275472; Expiration Date: Earliest Exp of Comp or 36mths. \n\n28.\tCatalog Number: 490560; Primary UDI-DI: 04046955275502; Unit of Dose UDI-DI: 04046955275496; Expiration Date: Earliest Exp of Comp or 36mths. \n\n29.\tCatalog Number: 490561; Primary UDI-DI: 04046955275526; Unit of Dose UDI-DI: 04046955275519; Expiration Date: Earliest Exp of Comp or 36mths. \n\n30.\tCatalog Number: 490562; Primary UDI-DI: 04046955275540; Unit of Dose UDI-DI: 04046955275533; Expiration Date: Earliest Exp of Comp or 36mths. \n\n31.\tCatalog Number: 490563; Primary UDI-DI: 04046955275564; Unit of Dose UDI-DI: 04046955275557; Expiration Date: Earliest Exp of Comp or 36mths. \n\n32.\tCatalog Number: 490569; Primary UDI-DI: 04046955275687; Unit of Dose UDI-DI: 04046955275670; Expiration Date: Earliest Exp of Comp or 36mths. \n\n33.\tCatalog Number: 490573; Primary UDI-DI: 04046955287451; Unit of Dose UDI-DI: 04046955287444; Expiration Date: Earliest Exp of Comp or 24mths. \n\n34.\tCatalog Number: 490574; Primary UDI-DI: 04046955287475; Unit of Dose UDI-DI: 04046955287468; Expiration Date: Earliest Exp of Comp or 24mths. \n\n35.\tCatalog Number: 490575; Primary UDI-DI: 04046955287499; Unit of Dose UDI-DI: 04046955287482; Expiration Date: Earliest Exp of Comp or 36mths. \n\n36.\tCatalog Number: 490578; Primary UDI-DI: 04046955287550; Unit of Dose UDI-DI: 04046955287543; Expiration Date: Earliest Exp of Comp or 36mths. \n\n37.\tCatalog Number: 490581; Primary UDI-DI: 04046955287611; Unit of Dose UDI-DI: 04046955287604; Expiration Date: Earliest Exp of Comp or 24mths. \n\n38.\tCatalog Number: 490582; Primary UDI-DI: 04046955287635; Unit of Dose UDI-DI: 04046955287628; Expiration Date: Earliest Exp of Comp or 36mths. \n\n39.\tCatalog Number: 490583; Primary UDI-DI: 04046955287659; Unit of Dose UDI-DI: 04046955287642; Expiration Date: Earliest Exp of Comp or 60mths. \n\n40.\tCatalog Number: 490588; Primary UDI-DI: 04046955287758; Unit of Dose UDI-DI: 04046955287741; Expiration Date: Earliest Exp of Comp or 36mths. \n\n41.\tCatalog Number: 490589; Primary UDI-DI: 04046955287772; Unit of Dose UDI-DI: 04046955287765; Expiration Date: Earliest Exp of Comp or 36mths. \n\n42.\tCatalog Number: 490600; Primary UDI-DI: 04046955352777; Unit of Dose UDI-DI: 04046955352760; Expiration Date: Earliest Exp of Comp or 24mths. \n\n43.\tCatalog Number: 490607; Primary UDI-DI: 04046955352913; Unit of Dose UDI-DI: 04046955352906; Expiration Date: Earliest Exp of Comp or 36mths. \n\n44.\tCatalog Number: 490608; Primary UDI-DI: 04046955352937; Unit of Dose UDI-DI: 04046955352920; Expiration Date: Earliest Exp of Comp or 36mths. \n\n45.\tCatalog Number: 490615; Primary UDI-DI: 04046955664672; Unit of Dose UDI-DI: 04046955664665; Expiration Date: Earliest Exp of Comp or 36mths. \n\n46.\tCatalog Number: 490618; Primary UDI-DI: 04046955664733; Unit of Dose UDI-DI: 04046955664726; Expiration Date: Earliest Exp of Comp or 24mths. \n\n47.\tCatalog Number: 490619; Primary UDI-DI: 04046955664757; Unit of Dose UDI-DI: 04046955664740; Expiration Date: Earliest Exp of Comp or 24mths. \n\n48.\tCatalog Number: 490644; Primary UDI-DI: 04046955765003; Unit of Dose UDI-DI: 04046955764990; Expiration Date: Earliest Exp of Comp or 36mths. \n\n49.\tCatalog Number: 490657; Primary UDI-DI: 04046955836420; Unit of Dose UDI-DI: 04046955836413; Expiration Date: Earliest Exp of Comp or 36mths. \n\n50.\tCatalog Number: 490658; Primary UDI-DI: 04046955836697; Unit of Dose UDI-DI: 04046955836680; Expiration Date: Earliest Exp of Comp or 36mths.", "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": "20,694,734 units", "distribution_pattern": "Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.", "openfda": { "k_number": [ "K970438", "K790582", "K991112", "K971004", "K931119", "K933390", "K800403", "K834252", "K833033", "K913333", "K924721", "K884264", "K912069", "K840273", "K143087", "K842985", "K052252", "K832104", "K141834", "K964844", "K961225", "K083765", "K251257", "K930751", "K811685", "K961474", "K990331", "K021530", "K781190", "K952852", "K984569", "K012879", "K823214", "K890176", "K090134", "K020629", "K003254", "K832549", "K000472", "K792228", "K050906", "K032854", "K052887", "K151969", "K940832", "K925219", "K023595", "K162804", "K072375", "K884511", "K802169", "K896561", "K041545", "K844255", "K011193", "K213846", "K881975", "K925731", "K990288", "K813194", "K914792", "K212262", "K852989", "K830194", "K140831", "K952242", "K882007", "K041844", "K171117", "K914074", "K860616", "K053106", "K873729", "K933898", "K180739", "K990693", "K203609", "K964455", "K062308", "K833741", "K042936", "K033515", "K051499", "K990388", "K950304", "K850769", "K830453", "K853327", "K905208", "K011928", "K905374", "K070362", "K113470", "K854628", "K872945", "K911931", "K070801", "K843249", "K143082", "K895290", "K812231", "K921429", "K833949", "K854446", "K061771", "K853086", "K760110", "K781575", "K221069", "K892440", "K871995", "K980992", "K950303", "K043235", "K021471", "K823346", "K861275", "K823347", "K802170", "K830755", "K031783", "K092930", "K921391", "K071421", "K853184", "K991301", "K931377", "K023769", "K801179", "K160870", "K861521", "K944692", "K112512", "K222766", "K895481", "K945070", "K935811", "K946082", "K781188", "K031917", "K070630", "K200425", "K082818", "K061115", "K811078", "K953225", "K914113", "K844917", "K925362", "K001329", "K980583", "K060352", "K230992", "K070547", "K900426", "K870913", "K020530", "K012754", "K897065", "K912860", "K780130", "K895367", "K910695", "K082306", "K885264", "K142097", "K860242", "K800878", "K902810", "K030246", "K120443", "K040710", "K834254", "K210381", "K844820", "K842984", "K031923", "K822836", "K860157", "K011405", "K850339", "K923882", "K023469", "K013714", "K971500", "K981792", "K854574", "K222780", "K140133", "K896291", "K133073", "K895046", "K942349", "K032934", "K883612", "K992290", "K021480", "K910159", "K014062", "K072542", "K012429", "K251814", "K141285", "K021080", "K020544", "K821032", "K932446", "K914924", "K130879", "K841562", "K781186", "K984146", "K111016", "K883318", "K871841", "K870582", "K952392", "K952074", "K060580", "K013164", "K220288", "K101368", "K790604", "K832434", "K813259", "K944293", "K955732", "K972527", "K013394", "K933852", "K912861", "K051939", "K911443", "K940296", "K051437", "K151079", "K171132", "K210430", "K960661", "K870188", "K895480", "K892429", "K051009", "K800638", "K926119", "K942988", "K934513", "K871753", "K122404", "K991932", "K810921", "K895291", "K182545", "K862491", "K232475", "K973167", "K013871", "K911868", "K121511", "K122686", "K943038", "K833030", "K864453", "K993463", "K993187", "K911753", "K854437", "K791529", "K040533", "K910546", "K202437", "K151151", "K142974", "K820747", "K893120", "K992104", "K884102", "K943897", "K010538", "K982123", "K083472", "K964876", "K800358", "K922558", "K060488", "K100720", "K884141", "K801004", "K930926", "K950302", "K032484", "K864338", "K190806", "K073050", "K020926", "K925930", "K063631", "K881052", "K771267", "K841859", "K885031", "K854436", "K934095", "K123344", "K894842", "K954841", "K970800", "K953791", "K032485", "K081289", "K243841", "K964850", "K861439", "K932637", "K014061", "K901729", "K770518", "K031279", "K002138", "K251375", "K072576", 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