{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "152617",
      "product_res_number": "Z-1234-2017",
      "event_date_initiated": "2016-09-20",
      "event_date_created": "2017-02-22",
      "recall_status": "Open, Classified",
      "res_event_number": "76276",
      "product_code": "FCH",
      "product_description": "CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.",
      "code_info": "Lots 40629-1609 an 40631-1609",
      "firm_fei_number": "3005474845",
      "recalling_firm": "Custom Medical Specialties, Inc.",
      "address_1": "330 East Main Street",
      "city": "Pine Level",
      "state": "NC",
      "postal_code": "27568",
      "additional_info_contact": "Diane McAlinn\n919-202-8462 Ext. 205",
      "reason_for_recall": "Sterility of syringe product could not be assured.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "A  letter was issued to customers on 9/20/2016 notifying them of the recall of the 10 cc syringe by BD. The letter tells them not to use the syringe in the kit, and to use the syringe on the outside of the kit which is not part of the recall.",
      "product_quantity": "80 syringes",
      "distribution_pattern": "US Distribution to ID and OR.",
      "openfda": {
        "device_name": "Tray, Biopsy, Without Biopsy Instruments",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.4730",
        "device_class": "1",
        "registration_number": [
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        "k_number": [
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}