{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "73723", "product_res_number": "Z-0407-2009", "event_date_initiated": "2008-08-22", "event_date_posted": "2008-12-12", "recall_status": "Terminated", "event_date_terminated": "2010-08-26", "res_event_number": "49522", "product_code": "GAZ", "product_description": "Mentor Aseptic Transfer Set, Cat. #350-8400 (contains BD 60mL Luer-Lok Syringe). Aseptic transfer set manufactured by Mentor Texas, LP, Irving, TX 75038 (BD 60 mL Luer-Lok syringe manufactured by Becton Dickinson, Franklin Lakes, NJ 07417).", "code_info": "Aseptic Transfer Sets: All lots.  Syringes: Reorder Number: 309653; Lot numbers beginning with the numbers 5, 6, or 7 and also the following lot numbers. 8010954, 8014571, 8031115, 8031117, 8031119, 8031124, 8031133, 8038154, 8038158, 8045564, 8045567, 8058890, 8058896, 8058898, 8058900, 8058902, 8072401, 8072409, 8072414, 8072419, 8079645, and 8079656.", "firm_fei_number": "1000118360", "recalling_firm": "Mentor Texas, Inc", "address_1": "3041 Skyway Cir N 3041 Skyway Cir", "city": "Irving", "state": "TX", "postal_code": "75038-3500", "additional_info_contact": "Steven Jackson\n972-252-6060", "reason_for_recall": "The Mentor Aseptic Transfer Set contains a component, the BD 60mL Luer-Lok Syringe, which is under recall by Becton Dickinson due to a package integrity issue.", "root_cause_description": "Package design/selection", "action": "Firm sent notification, along with a copy of the Becton Dickinson recall letter, to consignees on 08/18/08. Consignees asked to inspect inventory of Mentor Aseptic Transfer Sets for affected BD 60mL syringes and to complete and return the included Device Accountability Worksheet. For additional information, please contact Mentor Customer Service at 800-235-5731.", "product_quantity": "32,480 Aseptic Transfer Sets (4 syringes/set)", "distribution_pattern": "Worldwide Distribution; product sent to all states (except Alaska), Washington DC and Puerto Rico. 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"3027977504" ], "device_name": "Tubing, Noninvasive", "medical_specialty_description": "General Hospital", "regulation_number": "880.6740", "device_class": "2" } } ] }