{ "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": "113098", "product_res_number": "Z-0805-2013", "event_date_initiated": "2012-06-04", "event_date_posted": "2013-02-12", "recall_status": "Terminated", "event_date_terminated": "2014-01-08", "res_event_number": "63244", "product_code": "JXG", "k_numbers": [ "K020728", "K110206" ], "product_description": "Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide\n\nCentral Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.", "code_info": "Lots 4503489878, 4503792749, 4503682927, 4503508385, 4503789879, 4503800248 and 4503682935.", "firm_fei_number": "2916714", "recalling_firm": "Aesculap, Inc.", "address_1": "3773 Corporate Pkwy", "city": "Center Valley", "state": "PA", "postal_code": "18034-8217", "additional_info_contact": "800-258-1946 Ext. 5067", "reason_for_recall": "The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5 cm mark on the catheter. In some cases the surgeon will want to adjust the deflector to a different location on the catheter before placing it in the ventricle. There is a small percentage of cases where aggressively attempting to adjust the deflector has a potential to cause the catheter", "root_cause_description": "Process control", "action": "Aesculap sent an Important Recall Notification letter dated June 4, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the contact their local sales representative or customer service department at 1-800-282-9000 to return the affected product. Customers were also instructed to complete the Inventory Sheet attached to the letter with the quantity being returned. If customers could not locate the affected product they should provide an explanation as to why the inventory will not be returned. Customers with questions should call 610-984-9251 or 610-984-9291.\nFor questions regarding this recall call 1-800-234-9179, ext 5067.", "product_quantity": "11", "distribution_pattern": "Nationwide Distribution including MI, PA and TX.", "openfda": { "k_number": [ "K984583", "K120559", "K931989", "K081773", "K030081", "K963802", "K974708", "K854474", "K091328", "K984053", "K223330", "K944222", "K003564", "K902257", "K212641", "K854049", "K012052", "K021653", "K122118", "K252514", "K913636", "K200950", "K222471", "K911433", "K090342", "K920156", "K944595", "K233448", "K042359", "K102961", "K921936", "K050739", "K011030", "K902783", "K121248", "K171880", "K973525", "K024101", "K243531", "K903844", "K042465", "K873247", "K033850", "K862303", "K250636", "K870660", "K110206", "K924600", "K971617", "K855058", "K853363", "K981046", "K042481", "K162437", "K140722", "K243552", "K862907", "K964386", "K992465", "K955265", "K980903", "K040943", "K073139", "K760502", "K790849", "K922936", 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