{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "44484",
      "product_res_number": "Z-0678-06",
      "event_date_initiated": "2006-01-18",
      "event_date_posted": "2006-03-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-05-23",
      "res_event_number": "34692",
      "product_code": "MWH",
      "product_description": "Shelhigh No-React Pulmonic Valve Conduit.   **'Shelhigh No-React, Pulmonic Valve Conduit, NR4000-PA-C'** **'Shelhigh, Inc., 650 Liberty Ave., Union, NJ 07083  USA'** **'Shelhigh Porcine Pulmonic Valve Conduit Prosthesis Model NR-4000 Series with 'No-React' treatment*, INSTRUCTIONS FOR USE'**.",
      "code_info": "Model NR4000PA-C (size 6 mm), serial# PE19061, Lot# 030804-NR, Aug 2007 expiration Model NR4000PA-C (size 5 mm), serial# PE19089, Lot# 030924-NR, Sept 2007 expiration Model NR4000PA-C (size 6 mm), serial# PE20073, Lot# 040903-NR, Sept 2008 expiration Model NR4000PA-C (size 5 mm), serial# PE20678, Lot# 050222-NR, Feb 2009 expiration Model NR4000PA-C (size 6 mm), serial# PE20388, Lot# 050103-NR, Jan 2009 expiration Model NR4000PA-C (size 5 mm), serial# PE20677, Lot# 050222-NR, Feb 2009 expiration",
      "firm_fei_number": "1000081147",
      "recalling_firm": "Shelhigh, Inc.",
      "address_1": "650 Liberty Ave",
      "city": "Union",
      "state": "NJ",
      "postal_code": "07083-8130",
      "additional_info_contact": "Curtis Truesdale\n908-206-8706",
      "reason_for_recall": "Unapproved Device-Distribution of an unapproved device into interstate commerce.",
      "root_cause_description": "Other",
      "action": "The firm retrieved the 6 devices from the consignees identified, following a telephone request on 1/18/2006.  The firm does not consider this a recall.",
      "product_quantity": "25 units",
      "distribution_pattern": "The devices were supplied directly to hospital and Shelhigh sales reps.  There are two main accounts:  Children's Hopsital of Boston, MA and Products for Surgery, Scottsdale, AZ (Shelhigh authorized salesman).  The firm subsequently shipped a recalled unit, S/N PE20677 on 11/8/2005 to a European Distributor, Bioplan SRL, Parma, Italy. There are no Govt. accounts.",
      "openfda": {
        "device_name": "Pulmonic Valved Conduit",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "f",
        "registration_number": [
          "2025587"
        ],
        "fei_number": [
          "2025587"
        ]
      }
    }
  ]
}