{
  "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": "159840",
      "product_res_number": "Z-0323-2018",
      "event_date_initiated": "2017-11-17",
      "event_date_created": "2018-01-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-05-04",
      "res_event_number": "78588",
      "product_code": "MEA",
      "k_numbers": [
        "K032233"
      ],
      "product_description": "Alaris PCA Pump, Model 8120.  The firm name on the label is CareFusion.\n\nThe Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe pumps on the market. The modules are indicated for use on adults, pediatrics and neonates for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous, subcutaneous or epidural. The Alaris Syringe pump and PCA modules can be connected to the Alaris PC unit which is the central programming, monitoring, and power supply component for the Alaris System. The syringe pump and PCA pump uses standard, plastic piston syringes and single-use administration sets with luer-lock connectors.",
      "code_info": "UDI 10885403812002.  Product involved are those devices manufactured and/or serviced between 5/1/2013 through 4/30/2017.",
      "firm_fei_number": "2016493",
      "recalling_firm": "CareFusion 303, Inc.",
      "address_1": "10020 Pacific Mesa Blvd",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-4386",
      "additional_info_contact": "Michelle Badal\n858-617-5977",
      "reason_for_recall": "The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The recalling firm issued  \"Medical Device Safety Notification, dated November 17, 2017, via UPS.   The letter describes the potential issue, affected products, potential risks, and required action for the users.  The actions noted that clinicians can continue to use the device and follow the Alaris System User Manual for proper loading of the syringe.   Per the manual, clinicians should ensure the plunger grippers lock and hold the syringe plunger in place.  The Biomedical Engineering can detect if the device has this issue and if the issue described occurs, the user is to contact BD Support Center or email them to schedule service of the device at the BD Service Depot.\n\nEnclosed with the notification letter was a list of affected serial numbers, an excerpt from the user manual to \"Prepare Syringe and Administration Set (Syringe Module)\", and a customer response card to be returned via mail, email or FAX to confirm the notification has been received.\n\nFor further questions, please call (858) 617-5977.",
      "product_quantity": "73,611",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) Distribution. There was also government and military distribution. Foreign distribution was made to Canada, United Arab Emirates, Bahrain, Canada, Switzerland, United Kingdom, Kuwait, Mexico, Malaysia, The Netherlands, New Zealand, Qatar, Saudi Arabia, Taiwan, and South Africa.",
      "openfda": {
        "k_number": [
          "K043299",
          "K143612",
          "K915270",
          "K020421",
          "K910257",
          "K934551",
          "K092313",
          "K911791",
          "K033054",
          "K921994",
          "K030661",
          "K022203",
          "K130394",
          "K013822",
          "K043256",
          "K031566",
          "K032233",
          "K990312",
          "K915063",
          "K002434",
          "K982839",
          "K162165",
          "K002739",
          "K051253",
          "K914502",
          "K072144",
          "K943310",
          "K020418",
          "K170982",
          "K042800",
          "K920637"
        ],
        "registration_number": [
          "3013764800",
          "2029275",
          "3010082909",
          "3009456923",
          "9680425",
          "3010381606",
          "9615050",
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          "3011270181",
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          "2024064",
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          "3003879246",
          "2016493",
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          "2032112",
          "3013652261",
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          "9610825",
          "3012302888",
          "3007738736",
          "3009746061",
          "1047843",
          "3013319212",
          "3024706751"
        ],
        "fei_number": [
          "3013764800",
          "3010082909",
          "3009456923",
          "3010381606",
          "3003076831",
          "3002879653",
          "2025695",
          "3012337868",
          "3011270181",
          "1043214",
          "1000112968",
          "3018071447",
          "2024064",
          "3003879246",
          "2016493",
          "3008717264",
          "1000136478",
          "1000306431",
          "3013652261",
          "3004906872",
          "3002806469",
          "3007596547",
          "3012302888",
          "3007738736",
          "3009746061",
          "1047843",
          "1000112877",
          "3013319212",
          "3024706751",
          "3002999813",
          "3002558692"
        ],
        "device_name": "Pump, Infusion, Pca",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
      }
    }
  ]
}