{
  "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": "114061",
      "product_res_number": "Z-0430-2013",
      "event_date_initiated": "2012-10-17",
      "event_date_posted": "2012-11-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-12-05",
      "res_event_number": "63479",
      "product_description": "0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter\n\nProduct Usage:\nThe concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users to prepare inoculum with 0.45%-0.50% sodium chloride injections, and the system is designed to use 0.45%-0.50% sodium chloride concentration only.",
      "code_info": "Lot number C866715, EXP OCT 13",
      "firm_fei_number": "1950204",
      "recalling_firm": "Biomerieux Inc",
      "address_1": "595 Anglum Rd",
      "city": "Hazelwood",
      "state": "MO",
      "postal_code": "63042-2320",
      "additional_info_contact": "Ryan LeMelle\n314-731-8526",
      "reason_for_recall": "The firm inventoried and distributed 0.9% Sodium Chloride Saline bags as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system.",
      "root_cause_description": "Employee error",
      "action": "Biomerieux sent an Urgent Product Removal Notice letter dated October 16, 2012 to all affected customers via certified mail.  The letter identified the affected product, problem and actions to be taken.  Customers were instructed to discontinue use of the affected product and immediately discard any remaining inventory.  The letter included instructions on receiving product replacement or credit.    For questions or concerns contact your local BioMerieux representative.",
      "product_quantity": "199 cases/14-1000mL bags",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) including the states of: AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, TN, TX, VA and WI.  Distribution was also made to Canada, military facilities and other foriegn countries.",
      "openfda": {}
    }
  ]
}