{ "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": "140317", "product_res_number": "Z-0150-2016", "event_date_initiated": "2015-08-27", "event_date_created": "2015-10-21", "recall_status": "Terminated", "event_date_terminated": "2016-06-29", "res_event_number": "72237", "product_code": "CAZ", "k_numbers": [ "K962696" ], "product_description": "Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.", "code_info": "Product Catalog Number: 332215 332262 530024 530132 551714 551879 555184 555259 Lot Number 0061417406 0061421878 0061416371 0061420212 0061413247 0061416388 0061416389 0061414413", "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": "Customer Support\n610-596-2870", "reason_for_recall": "Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.", "root_cause_description": "Under Investigation by firm", "action": "BBMI provided written notification, dated August 27, 2015, to all customers in receipt of suspect product, along with acknowledgement forms detailing the suspect product that was distributed to each account. These customers include both BBMI direct end customers and BBMI direct distributors. Customers were notified by US Postal Service Certified Mail with registered return receipt mail or FedEx Priority. All customers were provided with instructions for disposition of suspect product in their inventory. 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