{
  "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": "36014",
      "product_res_number": "Z-0391-05",
      "event_date_initiated": "2004-11-19",
      "event_date_posted": "2005-01-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-11-03",
      "res_event_number": "30503",
      "product_code": "LKK",
      "pma_numbers": [
        "P860004"
      ],
      "product_description": "Model 8561 Lioresal (Baclofen injection) Intrathecal Refill Kit is designed for refilling the Medtronic SynchroMed family of pumps.  The 8561 kit contains a 1-20 ml ampule of 500 mcg/ml Baclofen injection along with a sterile refill kit tray and sterile drug preparation tray.  \n\nLioresal drug ampules contained witin Medtronic Lot N0016487 bear the primary manufacturer''s label and lot number 007J2583.  The drug box is labeled with Lot 017H1925. \n\nMedtronic packages a manufacturer''s labeled ampule into a protective drug box. A lot number and drug lot expiration date are printed on the outside of the drug box.  The filled and labeled drug box is placed inside a larger kit assembly that contains other components necessary to complete a pump refill.  Only the large kit assembly (''Lioresal Refill Kit'') will display the Medtronic lot number (N0016487).\n\nThe Model 8561 refill kit does not have a product code for itself; it is approved under PMA P860004.  PMA P860004 is classified as:  pump infusion, implanted, programmable under product code LKK.",
      "code_info": "N0016487",
      "firm_fei_number": "2182207",
      "recalling_firm": "Medtronic Inc, Neurological & Spinal Division",
      "address_1": "800 53rd Ave Ne",
      "city": "Columbia Heights",
      "state": "MN",
      "postal_code": "55421-1241",
      "additional_info_contact": "kyra Schmitt\n763-505-0237",
      "reason_for_recall": "Outer package of Lioresal Intrethecal Refill Kit, model 8561, identifies the kit to contain 1-20 ml ampule of baclofen injection for intrathecal administration, 500 mcg/ml (10 mg/20 ml).  Lot N0016487 incorrectly contains 1-20 ml ampule of baclofen concentration 2000 mcg/ml (40 mg/20 ml).",
      "root_cause_description": "Other",
      "action": "Customers were contacted 11/19/04 via telephone.  Customers were asked to set aside product and return the affected lot to Medtronic, Inc., Moundsview, MN.  Recalled product will be replaced by Medtronic.",
      "product_quantity": "96 kits were distributed to 34 customers",
      "distribution_pattern": "within the United States only",
      "openfda": {
        "pma_number": [
          "P990034",
          "P080012",
          "P140032",
          "P860004",
          "P800036",
          "P890055"
        ],
        "registration_number": [
          "3003120897",
          "3015537318",
          "3030198397",
          "3018094310",
          "2523676",
          "2135338",
          "2124215",
          "3007829657",
          "2032227",
          "2182207",
          "1722746",
          "1422634",
          "2246552",
          "2183319",
          "3004593495",
          "1526611",
          "3009183442",
          "3003174284",
          "3004209178"
        ],
        "fei_number": [
          "3003120897",
          "3015537318",
          "3003166194",
          "1000306216",
          "3030198397",
          "3018094310",
          "2523676",
          "2124215",
          "1000514656",
          "3005700659",
          "3007829657",
          "3004369318",
          "2182207",
          "2246552",
          "2183319",
          "3004593495",
          "1526611",
          "3009183442",
          "3003174284"
        ],
        "device_name": "Pump, Infusion, Implanted, Programmable",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}