{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "92791", "product_res_number": "Z-0306-2011", "event_date_initiated": "2010-06-24", "event_date_posted": "2010-11-05", "recall_status": "Terminated", "event_date_terminated": "2011-10-19", "res_event_number": "56164", "product_code": "LHI", "k_numbers": [ "K090905" ], "product_description": "B. Braun addEASE Binary Connector, Catalogue #N7993, 200 units (50 units per bag with 4 bags per shipping box) \n\nIntended for use in a pharmacy setting to connect a B. Braun 250mL Excel IV solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.", "code_info": "Lot Numbers:  60928513, 60936541, 60936543, 60942059, 60950900, 60953588, 60969534, 60972173, 60973280, 60983742, 60997643, 61003958, 61017469, 61027183, 61027186, 61031167, 61031168, 61042196, 61045157, 61056656, 61057867, 61058745, 61073202, 61078826, 61085625, 61096650, 61102775, 00VL907673, 00VL907677, 00VL912573, 00VL927133, 00VL927134, and 00VL927135.", "firm_fei_number": "2021236", "recalling_firm": "B. Braun Medical Inc", "address_1": "2525 McGaw Ave", "city": "Irvine", "state": "CA", "postal_code": "92614-5841", "additional_info_contact": "Bob Mitchell\n949-660-2730", "reason_for_recall": "During this insertion, fragmentation of the PAB container stopper may occur resulting in a small amount of visible particulates in the solution.", "root_cause_description": "Device Design", "action": "On July 8, 2010 B Braun sent an Urgent - Medical Device Recall letter, dated June 28, 2010, to consignees informing them of the recall and that further distribution or use of the affected product should cease immediately. The attached \"Product Removal Acknowledgement\" form should be used to record the number of units and full-unopened cases that customers have in their inventory. The completed form should be returned via mail or fax within 2 weeks of receipt. \n\nIf consignees have any full or partial cases of these affected products, they are to please call the Customer Support Department at (800) 227-2862 to arrange for return. Canadian customers may call (800) 624-2920. International customers may call (610) 691-5400. A Customer Support Representative will provide consignees with instructions for handling the affected product. The firm will arrange for unopened cases to be returned to B. Braun Medical, Inc. for proper disposal. Individual units (out of shipping cases) may be destroyed at the consignees facility.\n\nConsignees were informed that B. Braun is currently working to resolve this issue and provide an acceptable alternative to the market. They expect this product to be available in August 2010. In the interim, B. Braun PAB containers can continue to be used safely with a standard syringe and needle in accordance with the Direction for Use. If customers have additional questions regarding with a matter, they are to call B. Braun Customer Support Department at the number listed above. \n\nShould consignees identify product where this condition has occurred, consignees were asked to report it promptly to B. Braun Medical Inc. by contacting the B. Braun Clinical and Technical support at 1-800-854-6851.", "product_quantity": "2,500,000 units", "distribution_pattern": "Worldwide Distribution -- USA and Canada.", "openfda": { "k_number": [ "K013087", "K252987", "K090905", "K010703", "K203674", "K024239", "K240761", "K905201", "K140730", "K161800", "K052790", "K090917", "K012189", "K120150", "K832332", "K101309", "K243486", "K860595", "K260301", "K233284", "K861434", "K152441", "K894827", "K230988", "K190816", "K932462", "K132863", "K884626", "K853188", "K001293", "K023539", "K230464", "K843639", "K043304", "K904225", "K850757", "K041564", "K860113", "K120384", "K132040", "K943095", "K090634", "K202732", "K062482", "K844904", "K960466", "K972134", "K943181", "K072759", "K001831", "K042410", "K853830", "K142600", "K921365", "K872446", "K212530", "K080976", "K040456", "K162216", "K001368", "K832347", "K231071", "K120424", "K040634", "K852882", "K960921", "K860703", "K151423", "K912771", "K251715", "K233021", "K222718", "K970359", 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Fluid Transfer", "medical_specialty_description": "General Hospital", "regulation_number": "880.5440", "device_class": "2" } } ] }