{
  "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": "2026-08-20",
    "results": {
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  "results": [
    {
      "cfres_id": "115339",
      "product_res_number": "Z-0797-2013",
      "event_date_initiated": "2012-11-26",
      "event_date_posted": "2013-02-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-02-08",
      "res_event_number": "64084",
      "product_code": "FCH",
      "product_description": "Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case.\n\n\nProduct Usage:  A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.",
      "code_info": "LOT NO. 60812 EXPIRES: 11 /2012",
      "firm_fei_number": "1121091",
      "recalling_firm": "Custom Healthcare Systems, Inc.",
      "address_1": "4205 Eubank Rd",
      "city": "Richmond",
      "state": "VA",
      "postal_code": "23231-4328",
      "additional_info_contact": "R. Michael Chou\n804-421-5959",
      "reason_for_recall": "Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.",
      "root_cause_description": "Material/Component Contamination",
      "action": "Custom Healthcare Systems, Inc. sent an Urgent Recall Letter dated November 19, 2012 to all affected customers.  The letter identified the affected product, problem and actions to be taken.  Customers were instructed to check inventory, quarantine affected product and return affected product to Stericycle using the label provided with the letter.  Customer were also requested to complete and return the enclosed recall response form.  For questions contact Hospira Customer Care at 1-877-946-7747.",
      "product_quantity": "80 trays",
      "distribution_pattern": "USA Nationwide Distribution including the states GA, OH, GA, NC and ME.",
      "openfda": {
        "device_name": "Tray, Biopsy, Without Biopsy Instruments",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.4730",
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