{ "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": "196221", "product_res_number": "Z-0132-2023", "event_date_initiated": "2022-09-20", "event_date_posted": "2022-10-25", "recall_status": "Open, Classified", "res_event_number": "90924", "product_code": "LJT", "k_numbers": [ "K033473" ], "product_description": "Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling\n\nUPN: H787MPP5SAT0\nCatalog Number: MP-P5SAT", "code_info": "UDI-DI: 15051684018357\nLot Number: 5751582\nExp. Date: 31-Aug-2025", "firm_fei_number": "1319211", "recalling_firm": "Angiodynamics, Inc.", "address_1": "603 Queensbury Ave", "city": "Queensbury", "state": "NY", "postal_code": "12804-7619", "additional_info_contact": "SAME\n518-798-1215", "reason_for_recall": "Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, failure to follow the Instructions for Use may result in patient injury.", "root_cause_description": "Under Investigation by firm", "action": "Angiodynamics issued Urgent Medical Device Correction Letter on 09-20-2022 via Federal Express. Letter states reason for recall, health risk and action to take:\nIdentify if any of the affected product is in your inventory (whether in labs, Central Supply,\nShipping and Receiving or ANY other location).\n\" Place the supplied Instructions for Use with each of the affected product(s) in your possession\n\" Forward a copy of this recall notification and Instructions for Use to all sites to which you have distributed affected product.\n\nIf you have any questions regarding the corrective action as stated above, please call\nAngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday\n Friday: Eastern Standard Time).\n\" If additional Instructions for Use are required, please note the quantity needed on the enclosed\nReply Verification Tracking Form.\n\" Promptly complete, sign, and return the enclosed Reply Verification Tracking Form (even if you\ndo not have any product affected by this correction).\n Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com\n Fax Reply Verification Tracking Form:\nAttn: Vortex MP Correction Coordinator Fax number 1-855-273-0519", "product_quantity": "11 units", "distribution_pattern": "US Nationwide distribution in the states of AZ, CA, DC, IN, PA.", "openfda": { "k_number": [ "K870950", "K905842", "K875213", "K033686", "K964066", "K934802", "K022983", "K964538", "K260916", "K881075", "K994196", "K030636", "K122767", "K093414", "K190559", "K952537", "K973497", "K905851", "K952548", "K953529", "K070003", "K153359", "K871209", "K840481", "K915273", "K895871", "K953254", "K854019", "K921475", "K841150", "K090512", "K934518", "K953571", "K930206", "K924748", "K832917", "K091099", "K992880", "K153238", "K850888", "K896093", "K942623", "K934640", "K070116", "K881745", "K932095", "K921379", "K122834", "K863305", "K133335", "K832788", "K932841", "K934792", "K922896", "K032600", "K926011", "K905845", "K903691", "K924505", "K081472", "K974471", "K903364", "K952435", "K881342", "K934520", 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"device_name": "Port & Catheter, Implanted, Subcutaneous, Intravascular", "medical_specialty_description": "General Hospital", "regulation_number": "880.5965", "device_class": "2" } } ] }