{
  "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,
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  },
  "results": [
    {
      "cfres_id": "113637",
      "product_res_number": "Z-0156-2013",
      "event_date_initiated": "2012-10-03",
      "event_date_posted": "2012-10-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-02-15",
      "res_event_number": "63379",
      "product_code": "NEP",
      "product_description": "Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital pharmacies.  The device are Fluid Transfer Tube Sets, Sterile/EO, Std Volume Trifurcated, BAXA Corporation, Englewood, CO.\n\nThe Repeater Pump is a device that provides a peristaltic pump driven fluid transfer that facilitates repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers.",
      "code_info": "Repeater Pump model #s 095, 099, and 099R.",
      "firm_fei_number": "1419106",
      "recalling_firm": "Baxa Corporation",
      "address_1": "14445 Grasslands Dr",
      "city": "Englewood",
      "state": "CO",
      "postal_code": "80112-7062",
      "additional_info_contact": "303-690-4204",
      "reason_for_recall": "The firm is issuing a field correction to the operators manual included with the 099 Repeater Pump because the Technical Manual was distributed with the device as opposed to the Operator Manual and the instruction for use contradict each other with regards to multiple source container use.",
      "root_cause_description": "Packaging process control",
      "action": "Baxa Corporation sent a \"REPEATER PUMP PRODUCT NOTICE\"  to all affected customers.  The letter identified the product, problem, and actions to be taken by the customers. All customers received a CD containing a copy of the correct Operator Mannual, 5300-0754.  Contact Technical Support at 800-678-2292 for questions regarding this notice.",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of  Argentina, Australia, Brazil, Canada, Columbia, Guam, Japan, Malaysia, Mexico, Panama, Puerto Rico, Taiwan, UK, and Venezuela.",
      "openfda": {
        "registration_number": [
          "3003704957",
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        "fei_number": [
          "3003704957",
          "3007880912",
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          "3002669612",
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          "1000306431",
          "3010291427",
          "1416980",
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          "1000632857",
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        ],
        "device_name": "System/Device, Pharmacy Compounding",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5440",
        "device_class": "2"
      }
    }
  ]
}