{ "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": "221227", "product_res_number": "Z-3080-2026", "event_date_initiated": "2026-08-19", "event_date_posted": "2026-09-15", "recall_status": "Open, Classified", "res_event_number": "99298", "product_code": "FPA", "k_numbers": [ "K022209" ], "product_description": "BD Alaris Pump Infusion Sets\n10561554*\t10885403232565\t50885403232563\tBD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites\n10015861A\t10885403232626\t50885403232624\tBD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Back Check Valve, 3 SmartSite Y-sites\n11171447*\t7613203021234\t37613203021242\tBD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite 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"firm_fei_number": "3012798826", "recalling_firm": "BD SWITZERLAND SARL", "address_1": "17 terre bonne park a4 route de crassier", "city": "Eysins", "country": "Switzerland", "additional_info_contact": "Amanda Pearson\n970-836-2687", "reason_for_recall": "Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.", "root_cause_description": "Device Design", "action": "On 08/19/2026, an \"URGENT MEDICAL DEVICE CORRECTION\" letter was sent via FedEx and other courier services informing customers that, the BD Alaris\" Pump Module Model 8100, when used with some BD Alaris\" Pump Infusion Sets at low flow rates or to deliver low bolus volumes, may perform worse than previously disclosed. Due to the difficulty in recognizing these performance issues, users may fail to identify them as the cause of clinically significant changes in a patient's condition. Performance attributes that differ from previously communicated values have the potential to result in greater degrees of under / overinfusion, delayed time to occlusion alarms, and bolus dose inaccuracies.\n\nThe Recall Notificaiton provides Clinical Recommendations for Sets with Updated Performance.\n\nCustomers are instructed to:\nImmediately discard any sets listed within Attachment C: Discontinued Alaris\" Pump Sets per your facility s procedures.\na. To receive credit for discarded product, please return the completed Customer Response Form attached to this notice.\nIf a set is included on Attachment C as discontinued, identify an alternate BD Alaris\" Pump infusion set that is clinically appropriate and specific to the use case. If alternate sets are limited in quantity, they should be prioritized for use in critical-care, neonatal, infant, and pediatric care areas.\n\n1. Review Attachments A, B, C and D and make any necessary adjustments to clinical use or set selection. Forward this communication to all areas of the facility where sets are being used.\n2. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification.\n\nFor questions or assistance- contact BD Technical Support at 866-488-1408\nPhone hours: 5:00 am to 5:00 pm PT\nMonday Friday\nCreate a case at:\nhttps://bd.com/self-service\n\nor Alarismedicalaffairs@bd.com for clinical questions.", "product_quantity": "94,230,757", "distribution_pattern": "U.S.: Nation-wide - AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.\n\nO.U.S.: \nAustralia\nBelgium\nBahrain\nBotswana\nCanada\nCuba\nChina\nFrance\nGermany\nGibraltar\nIsrael\nIndia\nItaly\nJapan\nKorea, Republic of\nKuwait\nMexico\nMalaysia\nNetherlands\nNew Zealand\nPhilippines\nPakistan\nQatar\nSaudi Arabia\nSingapore\nSouth Africa\nSwitzerland\nTaiwan, Province of China\nTurkey\nUnited Arab Emirates\nUnited Kingdom", "openfda": { "k_number": [ "K251375", "K150860", "K965027", "K171117", "K834252", "K822406", "K832622", "K031917", "K062308", "K213089", "K840619", "K992999", "K161898", "K840273", "K002006", "K090134", "K873042", "K223088", "K800711", "K930406", "K051499", "K161036", "K781186", "K940053", "K983217", "K984060", "K071846", "K023769", "K821515", "K914924", "K852259", "K823214", "K864296", "K891164", "K921429", "K921860", "K020424", "K863814", "K940056", "K191658", "K871753", "K792560", "K162951", "K182545", "K934513", "K061115", "K222889", "K192366", "K132142", "K221481", "K203796", "K010103", "K062909", "K150921", "K781812", "K133867", "K811685", "K954983", "K823845", "K854754", "K070430", "K100432", "K913311", "K011120", "K021395", "K854636", "K822027", "K173879", "K880482", "K941190", "K853287", "K213004", "K930854", "K013394", "K952760", "K142622", "K242763", 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