{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "203395", "product_res_number": "Z-0131-2024", "event_date_initiated": "2023-09-26", "event_date_posted": "2023-11-03", "recall_status": "Open, Classified", "res_event_number": "93074", "product_code": "DXT", "product_description": "30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.", "code_info": "UDI-DI: N/A\n\nLots 0061766049", "firm_fei_number": "2523676", "recalling_firm": "B. Braun Medical, Inc.", "address_1": "901 Marcon Blvd", "city": "Allentown", "state": "PA", "postal_code": "18109-9512", "additional_info_contact": "BBMI Postmarket Surveillance Department\n888-425-1464", "reason_for_recall": "Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.", "root_cause_description": "Process control", "action": "On September 26, 2023, the firm notified customers via Urgent Product Recall Notification letters. Customers were informed of the potential for leakage at the male Luer lock site.\n\nCustomers were instructed to report total amount of impacted product on hand to the firm, after which B Braun Customer Support will contact the customer with instructions on how to return the product for credit or replacement depending on the customer's need.\n\nQuestions about this recall may be reported to BBMI s Postmarket Surveillance Department by calling 1-833-425-1464.", "product_quantity": "350 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada and Singapore.", "openfda": { "k_number": [ "K230668", "K863037", "K132928", "K140425", "K170279", "K923117", "K172694", "K090621", "K143538", "K901382", "K873410", "K875324", "K152218", "K880493", "K800823", "K042784", "K112086", "K211564", "K863537", "K152906", "K052633", "K190102", "K131478", "K880877", "K140469", "K884913", "K170431", "K991557", "K993728", "K152978", "K880987", "K252638", "K120892", 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