{ "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": "219065", "product_res_number": "Z-1798-2026", "event_date_initiated": "2026-03-19", "event_date_posted": "2026-04-15", "recall_status": "Open, Classified", "res_event_number": "98552", "product_code": "FJK", "k_numbers": [ "K080807" ], "product_description": "B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. \nModel Number: SL-2010M2096A.", "code_info": "Model Number SL-2010M2096A; UDI-DI Primary: 04046955674992; UDI-DI Unit: 04046955735280; All lots manufactured since 09JUN2025", "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 the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.", "root_cause_description": "Device Design", "action": "B. Braun notified consignees on about 03/19/2026 via letter titled URGENT MEDICAL DEVICE CORRECTION. Consignees were instructed to use alternative dialysis equipment and disposables, if possible. If not, BBMI recommends the following actions that can help mitigate potential harm should you need to use sets impacted by this field action on patients: \n\n1.\tEnsure full adherence to both the bloodline and dialysis machine Instructions for Use (IFU).\na.\tStreamline bloodlines - strict adherence to the priming process as outlined in the IFU, with special emphasis on Step 26.\nb.\tB3 bloodlines - strict adherence to the priming process as outlined in the IFU, with special emphasis on Step 12.\n2.\tIf possible, avoid high flow during treatment if small air bubbles are present.\n3.\tAvoid retrograde rinseback if small air bubbles are present.\n4.\tBe alert for a follow-up communication indicating the issue is resolved.\n\nConsignees were also instructed to review the customer notification its entirety, ensure all affected personnel are notified and aware of the issue, post the notification where the affected products are stored, and complete and return the response form. For distributors, they were instructed to forward the notification to all consignees as this recall extends to the consumer level.\n\nB. Braun will provide a follow up communication to users when lots with corrective actions are available, and users may resume high flow treatment and use of retrograde rinseback where indicated.", "product_quantity": "3,158,104 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the country of Canada.", "openfda": { "k_number": [ "K892932", "K072024", "K000451", "K213992", "K992039", "K161582", "K120823", "K150304", "K080807", "K001873", "K210782", "K830677", "K853851", "K873455", "K251442", "K952631", "K853962", "K950247", "K100364", "K864784", "K902426", "K090255", "K140841", "K920797", "K252423", "K901688", "K801016", "K251341", "K243607", "K983559", "K873516", "K792054", "K921597", "K870722", "K860740", "K811839", "K771693", "K831424", "K013634", "K201866", "K852309", "K903021", "K171952", "K962081", "K012242", "K063290", "K202796", "K971313", "K001107", "K810823", "K820169", "K112628", "K810824", "K852605", "K982340", "K953823", "K780681", "K831747", "K032975", "K934803", "K792053", "K851236", "K802874", "K812685", "K971687", "K801211", "K992930", "K063293", "K070414", "K854271", "K884243", "K896407", "K910558", "K761326", "K821138", "K913526", "K014140" ], "registration_number": [ "3010291427", "1056186", "9680579", "3009746061", "3005578748", "3000247873", "2032098", "3015349756", "3013217742", "3043014136", "3032143970", "3004960482", "2028411", "3014936217", "2024024", "8030639", "3042158867", "9611824", "3030446844", "3010355846", "3010377171", "3044744771", "3035708507", "3006755813", "9611823", "3008044552", "1650907", "3032828299", "3006849754", "3011163668", "8030638", "3006795797", "3020689844", "8041145", "3004111573", "9611369", "3038138522", "3038195011", "3043534762", "3013536188", "3004530184", "3013671177", "3005162618", "1649518", "3013764800", "2025816", "8030665", "1018470", "2029275", "1225714", "3014279513", "3003589956", "3013546453", "2032112", "3016096143", "3017636737", "3005246939", "2521402", "9614279", "3017552925", "9616419", "9617594", "9610270", "3015335038", "2011171" ], "fei_number": [ "3010291427", "3001451489", "1000306431", "3009746061", "3005578748", "1527681", "3000247873", "3015349756", "3002807005", "3013217742", "3043014136", "3032143970", "3004960482", "3014936217", "3002807744", "2024024", "3002807035", "3042158867", "1000203464", "3030446844", "3010355846", "3010377171", "3044744771", "3035708507", "3006755813", "3008044552", "3032828299", "3003807466", "3006849754", "3011163668", "3006795797", "3020689844", "3004111573", "3038138522", "3003058448", "3038195011", "3043534762", "3013536188", "3004530184", "3013671177", "1000132332", "3002806727", "1000125241", "3002681132", "2025816", "1018470", "3003656001", "3014279513", "3003589956", "3003767881", "3013546453", "3012394756", "3016096143", "3001236277", "3017636737", "3005246939", "2521402", "3003076831", "3017552925", "3002806960", "3002974635", "6898", "3013764800", "3015335038", "2011171" ], "device_name": "Set, Tubing, Blood, With And Without Anti-Regurgitation Valve", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5820", "device_class": "2" } } ] }