{ "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": "74869", "product_res_number": "Z-0604-2009", "event_date_initiated": "2008-06-30", "event_date_posted": "2008-12-30", "recall_status": "Terminated", "event_date_terminated": "2009-01-02", "res_event_number": "50154", "product_code": "KRA", "k_numbers": [ "K983003" ], "product_description": "MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular\n\nIntended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the Neurovascular, Peripheral Vascular and Coronary Vascular systems and for superselective angiography of peripheral and coronary vasculature.", "code_info": "Lot Number 13358689 and 13350390.", "firm_fei_number": "1016427", "recalling_firm": "Cordis Corporation", "address_1": "14201 Nw 60th Ave", "city": "Miami Lakes", "state": "FL", "postal_code": "33014-2802", "additional_info_contact": "786-313-2000", "reason_for_recall": "Two lots of Cordis Neurovascular Masstransit Infusion Catheter Kits has the potential for sterile PTFE contamination within the inner lumen of the catheter.", "root_cause_description": "Pending", "action": "A Medical Device Recall letter, dated 6/30/2008, and Acknowledgement Form were sent overnight. The firm asked customers to set aside any affected product in a manner that ensures it will not be used. Customers are asked to review, sign and return the enclosed Acknowledgement Form directly to Cordis Neurovascular. Customers can either return any product with reference to the RA# on the form, or contact their local sales reps to facilitate return of the affected product. Customers will receive a credit for the units they return. If any affected product has been forwarded to another facility, the facility should be contacted to arrange return of the product. If there are any additional questions, Customer Service may be also be contacted at 800-551-7683.", "product_quantity": "27", "distribution_pattern": "Nationwide Distribution --- including states of Colorado, Connecticut, Florida, Minnesota, Nebraska, Nevada, Ohio, Oregon, and Virginia.", "openfda": { "k_number": [ "K010004", "K153502", "K082519", "K111490", "K101450", "K964868", "K971306", "K931335", "K993266", "K953133", "K070279", "K040139", "K230636", "K172081", "K214025", "K082613", "K072724", "K180275", "K210114", "K952874", "K951602", "K231279", "K023351", "K003925", "K951502", "K070979", "K801173", "K100892", "K161962", "K860570", "K211525", "K153501", "K132947", "K924661", "K223176", "K885281", "K062752", "K093750", "K142259", "K113773", "K111263", "K034036", "K954020", "K832058", "K914751", "K780479", "K123477", "K161921", "K923368", "K033913", "K042187", "K250794", "K000177", "K052738", "K212719", "K030688", "K231148", "K874242", "K060224", "K243534", "K202318", "K955525", 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