{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "37535",
      "product_res_number": "Z-0782-05",
      "event_date_initiated": "2005-02-25",
      "event_date_posted": "2005-04-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-08-09",
      "res_event_number": "31251",
      "product_code": "LLD",
      "k_numbers": [
        "K031844"
      ],
      "product_description": "Vaxcel Low Profile Port with PASV valve and 8F Polyurethane Catheter.  CATALOG NO. 45-238, Ref. # M001452380.  FIRM ON LABEL:  Boston Scientific MEDI-TECH.  Manufactured for:  Boston Scientific Corp., One Boston Scientific Place, Natick, MA  01760-1537.  Manufactured at:  10 Glens Falls Technical Park, Glens Falls, NY  12801.",
      "code_info": "Cat. No. 45-238 including all lots as follows: 791484, 791485, 906777, 916195, 916196, 916197, 917026, 918870, 919481, 920550, 921765, 924851D",
      "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": "Potential separation of the port base from the port cover after implantation.",
      "root_cause_description": "Other",
      "action": "Letters sent 3/11/2005 via Federal Express to hospitals receiving affected product. Customers instructed to remove/return product, notify physicians, evaluate patients and explant devices whenever possible.",
      "product_quantity": "841 units",
      "distribution_pattern": "1215 units shipped to 123 hospitals throughout the U.S.  2 units shipped to Boston Scientific in South Africa where 1 unit had been used as a demo (non-human use) and 1 units is in BSC control",
      "openfda": {
        "device_name": "Port & Catheter, Implanted, Subcutaneous, Intraperitoneal",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5965",
        "device_class": "2",
        "k_number": [
          "K832906",
          "K864552",
          "K862412",
          "K880072"
        ],
        "registration_number": [
          "2032112",
          "9617604"
        ],
        "fei_number": [
          "3002558692",
          "3003076831"
        ]
      }
    }
  ]
}