{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82143",
      "recalling_firm": "CareFusion 303, Inc.",
      "address_1": "10020 Pacific Mesa Blvd",
      "address_2": "N/A",
      "postal_code": "92121-4386",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - U.S. Nationwide CA, TX, NC, AL, ID, TN, IN, MA, UT, HI, NH, PA, IL, OR, FL, MI, VA, AR, OH, GA, NY, MD, MN, NM, AZ, KY, WI, NE, MS, DC, MO, KS, SC, LA, MT, WA, NJ, CO, CT, OK, AK, AS, CU, DE, GU, IA, ME, MP, ND, NV, PR, SD, VT, WV, WY;    OUS: AE, AU, BH, CA, CH, CN, GI, IL, IN, KW, MX, MY, NL, NZ, PH, PK, QA, SA, SG, TW, and ZA.",
      "recall_number": "Z-1768-2019",
      "product_description": "Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin.    The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic.     Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N 10942012, P/N 49000007, and P/N 49000203), and   Alaris Pump module Bezel Kit Assembly (P/N 10964559 and P/N 49000204).        Product Usage:  The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural. There are 6 bezel posts on the Alaris Pump bezel assembly.",
      "product_quantity": "607618",
      "reason_for_recall": "The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening.  A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e. external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion.",
      "recall_initiation_date": "20180413",
      "center_classification_date": "20190716",
      "termination_date": "20231226",
      "report_date": "20190724",
      "code_info": "All pumps manufactured between April 2011 and June 2017, that have bezel mechanical assemblies manufactured with FR-110 plastic resin. And all pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic."
    }
  ]
}