{ "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": "36142", "product_res_number": "Z-0405-05", "event_date_initiated": "2004-11-22", "event_date_posted": "2005-01-20", "recall_status": "Terminated", "event_date_terminated": "2005-12-16", "res_event_number": "30572", "product_code": "LJS", "k_numbers": [ "K021704" ], "product_description": "VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-452; UPN #M001454520. Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA . Manufactured at 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin. Each KIT contains: Catheter; caps; tape measure, 60 cm length;stylet; stylet guide/flush assembly; attachable suture wing; statlock catheter securement device; instructions for use; 21 gauge, 1.5 inch introducer needle with echogenic tip; 30 cm floppy tip guidewire; 5cm peelable introducer sheath with locking dilator; 10 ml syringe; scalpel, CSR wrap.", "code_info": "933285; 982726", "firm_fei_number": "3001451463", "recalling_firm": "Boston Scientific Corporation", "address_1": "1 Boston Scientific Pl", "city": "Natick", "state": "MA", "postal_code": "01760-1536", "additional_info_contact": "Marie Peters\n508-652-5875", "reason_for_recall": "Catheter separation immediately distal to the nose of the suture wing.", "root_cause_description": "Other", "action": "Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated.", "product_quantity": "158 kits", "distribution_pattern": "75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.", "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", "K150527", "K161765", "K133264", "K010349", "K050542", "K070615", "K960055", "K861563", "K843450", "K130507", "K910315", "K062579", "K180567", 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Intravascular, Therapeutic, Long-Term Greater Than 30 Days", "medical_specialty_description": "General Hospital", "regulation_number": "880.5970", "device_class": "2" } } ] }