{
  "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": "35685",
      "product_res_number": "Z-0433-05",
      "event_date_initiated": "2004-11-03",
      "event_date_posted": "2005-01-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-05-07",
      "res_event_number": "30301",
      "product_code": "MEA",
      "k_numbers": [
        "K033054"
      ],
      "product_description": "Harvard 2 Syringe Pump manufactured for Rita Medical (OEM)\nModel Number 2005-001",
      "code_info": "Serial number range 218002222 - 218002382     02R00222 - 02R002382 318002383 - 318002426",
      "firm_fei_number": "1218257",
      "recalling_firm": "Harvard Clinical Technology",
      "address_1": "22 Pleasant Street",
      "city": "Natick",
      "state": "MA",
      "postal_code": "01760",
      "additional_info_contact": "Daniel  B. Laferriere\n781-596-7750",
      "reason_for_recall": "Potential pump motor/encoder assembly failure may cause over infusing medication in patients",
      "root_cause_description": "Other",
      "action": "Harvard Clinical Technology notified  consignees by letter on 11/3/04. Harvard will contact consignees by telephone to schedule a return. The motors inside the recalled products will be replaced at Harvard Clinical. Harvard will provide Loaner pumps upon request during the repair process.",
      "product_quantity": "204 units",
      "distribution_pattern": "AK, KY, TX, MA, NY, CA, GA, OK, IL, CT, LA, FL, MD,NC, NJ, VA, MI, WI, IA, WV,OH,",
      "openfda": {
        "k_number": [
          "K130394",
          "K934551",
          "K032233",
          "K030661",
          "K002739",
          "K013822",
          "K092313",
          "K042800",
          "K910257",
          "K043256",
          "K043299",
          "K031566",
          "K072144",
          "K143612",
          "K911791",
          "K920637",
          "K982839",
          "K914502",
          "K051253",
          "K915063",
          "K990312",
          "K022203",
          "K943310",
          "K033054",
          "K170982",
          "K002434",
          "K915270",
          "K162165",
          "K020418",
          "K020421",
          "K921994"
        ],
        "registration_number": [
          "9615050",
          "3009456923",
          "3004906872",
          "1055236",
          "1047843",
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          "2032112",
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          "2029275",
          "9680425",
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        ],
        "fei_number": [
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          "3004906872",
          "1047843",
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          "3013652261",
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          "1000306431",
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          "3011270181",
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        ],
        "device_name": "Pump, Infusion, Pca",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
      }
    }
  ]
}