{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "203320", "product_res_number": "Z-0115-2024", "event_date_initiated": "2023-08-31", "event_date_posted": "2023-10-13", "recall_status": "Open, Classified", "res_event_number": "93043", "product_code": "LJS", "k_numbers": [ "K213550" ], "product_description": "HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004", "code_info": "UDI-DI: 00850030354068;\nLot Number: 11469666", "firm_fei_number": "3021570645", "recalling_firm": "Access Vascular, Inc", "address_1": "749 Middlesex Tpke", "city": "Billerica", "state": "MA", "postal_code": "01821-3906", "additional_info_contact": "Brian Hanley\n781-538-6594", "reason_for_recall": "Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.", "root_cause_description": "Error in labeling", "action": "An Urgent Medical Device Correction notification letter dated 8/25/23 was sent to customers.\n\nOur records indicate that your facility has received kits from the affected lots. We are contacting you to provide information on action to take to ensure patient safety.\n- Product that has already been used: No action required. All catheters to date have been used with adult patients.\n- Product that has not been used: The kit does not have the current IFU. Please refer to the Rev C. IFU provided with this letter. Also, the Patient Information Card, part number LS-067, includes a barcode link to the current revision of the IFU on AVIs website.\n\nThe following page identifies the shipments you have received with these impacted lots. Please forward this notice in the event the affected product was further distributed. We will contact you to identify the number of kits that are currently in your inventory and determine the appropriate correction with your input, in a timely manner.\n\nIf you have any questions about this communication, please contact us at 781-538-6594.", "product_quantity": "58 total", "distribution_pattern": "US Nationwide distribution in the states of IL, TX.", "openfda": { "k_number": [ "K081904", "K153469", "K173956", "K932430", "K903648", "K172039", "K150448", "K180548", "K063848", "K063240", "K131687", "K152819", "K210264", "K213550", "K232594", "K970434", "K832774", "K160925", "K897168", "K051690", "K093366", "K170486", "K113808", "K073451", "K060887", "K841878", "K832580", "K070996", "K040446", "K153423", "K130034", "K072625", "K193015", "K241587", "K833442", "K964556", "K930630", "K834091", "K122423", "K831587", "K831845", "K935145", "K101326", "K171931", "K840958", "K883313", "K072391", "K141633", "K963215", "K091670", "K120981", "K001901", "K232571", "K051417", "K201452", 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"3016727301", "3007544874", "3002808464", "1000314502", "1018233", "3015309643", "3013501772", "3000209794", "3005747797" ], "device_name": "Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days", "medical_specialty_description": "General Hospital", "regulation_number": "880.5970", "device_class": "2" } } ] }