{ "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": 1 } }, "results": [ { "cfres_id": "220006", "product_res_number": "Z-2514-2026", "event_date_initiated": "2026-05-21", "event_date_posted": "2026-06-18", "recall_status": "Open, Classified", "res_event_number": "98855", "product_code": "FMG", "k_numbers": [ "K974083" ], "product_description": "BD Connecta\" BD Luer-Lok\" 360 REF 394910\r\nUDI-DI code: 00382903949106\r\n\r\nBD Connecta\" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV lipid nutritional products, the stopcock device can be used for up to 24 hours.", "code_info": "Catalog/Model Number: 394910\nUDI-DI code: 00382903949106\nLot Numbers:\n4277968\n4277973\n4282451\n4282461\n4289801\n4290582\n4292904\n4295848\n4299949\n4303841\n4305108\n4306700\n5129635\n5129642\n5129649\n5129650\n5129651\n5139250\n5139251\n5139252\n5150181\n5153940\n5164061\n5164062\n5178078\n5181442\n5183810\n5183816\n5183824\n5183828\n5218287\n5218291\n5218293\n5218299\n5218302\n5241476\n5247729\n5247731\n5251098\n5275601\n5275602", "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": "Fallon McLoughlin\n201-258-0361", "reason_for_recall": "Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.", "root_cause_description": "Device Design", "action": "On 05/21/2026, the firm sent via email and FedEx an \"URGENT: Medical Device Correction\" Letter informing customers that, BD has identified an observed issue in how Port C of the BD Connecta Stopcocks operates during use. Reports received indicate that when using polypropylene plastic luer lock syringes, the connection at Port C may over thread the syringe and continue to spin. This behavior has led some clinical users to perceive the connection as unstable.\n\nActions for Clinical Users:\n-Per current Instructions for Use:\n\"Do not overtighten connections. Note: Resistance between the male luer connector and the BD Connecta Stopcock when rotating indicates the connection is fully engaged and secure.\nInstruction to follow:\n1.Circulate this notice to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred.\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.\n3.Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via:\nWeb: MedWatch website at www.fda.gov/medwatch\nPhone: 1-800-FDA-1088 (1-800-332-1088)\nMail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787\n4.Report any complaints experienced with the use of this product to BD via the North American Regional Complaint Center:\nPhone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted Mon Fri 8:00am and 5:00pm CT\nEmail: productcomplaints@bd.com\n\nFor Questions:\nPhone: 1-844-8BD-LIFE (1-844-823-5433)\nSay Product Complaints when prompted Mon Fri 8:00am and 5:00pm CT\nor Email: productcomplaints@bd.com", "product_quantity": "2,465,500 units", "distribution_pattern": "U.S.: AK, AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.\n\nO.U.S.: Japan", "openfda": { "k_number": [ "K854348", "K964435", "K782167", "K060231", "K823373", "K862691", "K810375", "K770916", "K210516", "K082106", "K881805", "K080077", "K800864", "K812927", "K123084", "K760667", "K860889", "K802258", "K954984", "K760679", "K032393", "K211204", "K840394", "K842173", "K792125", "K071400", "K760666", "K830198", "K242255", "K771911", "K082836", "K851986", "K884435", "K780662", "K864900", "K884463", "K223175", "K012157", "K190539", "K800284", "K940070", "K864440", "K800863", "K853275", "K902724", "K850280", "K010217", "K792128", "K823120", "K823469", "K141254", "K782168", "K053405", "K082110", "K911415", "K770708", "K061143", "K770707", "K780596", "K891234", "K974083", "K792127", "K870324", "K982368", "K760678", "K792124", "K872067", "K041779", "K862492", "K223499", "K820165", "K172266", "K955782", "K954970", "K870261", "K130245", "K792126", "K961982", "K932512", "K962581", "K913560", "K953573", "K800862", "K052330", "K070143", "K022895", "K190489", "K790010", "K872066" ], "registration_number": [ "3013557562", "1061124", "1060680", "3012261967", "3005012805", "3013683058", "9610849", "3012798826", "2243072", "1319639", "9615817", "3012410077", "1526863", "9616088", "3045322464", "1220477", "1649914", "9614279", "1416980", "3005941719", "9617594", "2032098", "1423507", "1043214", "1423537", "1518293", "3006950086", "3033589330", "3009211636", "1644312", "3006425876", "3002907620", "1055236", "9612052", "2025816", "2523676", "1018470", "1223004", "2032112", "3015309643", "1000563940", "2022435", "3030447506", "3015276780", "1030451", "1424263", "1054241", "1047843", "3013517171", "2024024", "3006891665", "8040700", "9613418", "1713468", "1423662", "3020778", "2245270", "1625425", "9610847", "3017636737", "3032916632", "3007738736", "3010432890", "3010041511", "1928237", "9612152", "8020616", "3003704957", "3033536319", "3012809732", "3015085713", "9680794", "3012536737", "3006475220", "9616567", "3013188547", "2320762", "3004111573", "3007344957", "3035642068", "2029275", "3007017524", "3015173212", "1047429", "3013764800", "3010421104", "2011171" ], "fei_number": [ "3013557562", "3002806443", "3012261967", "1000208624", "3005012805", "1000112877", "3002963732", "3013683058", "3003807466", "3012798826", "2243072", "3003081151", "3012410077", "1526863", "3003767881", "3045322464", "1220477", "3001236905", "1416980", "3002807111", "1000512168", "1000306431", "3003040625", "1043214", "1518293", "3002806901", "3006950086", "3033589330", "3009211636", "3003015552", "1000117748", "3006425876", "3002907620", "2025816", "2523676", "1018470", "1000138054", "3015309643", "1000563940", "2022435", "1000120555", "3030447506", "3015276780", "3001665800", "1030451", "1047843", "3002806476", "3013517171", "3008002452", "3002879021", "2024024", "3006891665", "1713468", "3020778", "3001044237", "2245270", "1625425", "3003737899", "3017636737", "3032916632", "3007738736", "3010432890", "3010041511", "1928237", "3003704957", "3033536319", "3012809732", "3015085713", "1000112968", "3012536737", "3006475220", "3013188547", "3000215273", "3004111573", "3003058448", "3007344957", "3035642068", "3007017524", "3015173212", "3002807391", "3003076831", "3002806588", "1047429", "3013764800", "3010421104", "2011171", "3002902735" ], "device_name": "Stopcock, I.V. Set", "medical_specialty_description": "General Hospital", "regulation_number": "880.5440", "device_class": "2" } } ] }