{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "184178",
      "product_res_number": "Z-0449-2021",
      "event_date_initiated": "2020-07-14",
      "event_date_created": "2020-11-13",
      "recall_status": "Open, Classified",
      "res_event_number": "86607",
      "product_code": "LIO",
      "product_description": "Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.",
      "code_info": "Lots  060620MB1 \t061420MB2 \t062120MB1 \t062220MB2 \t060620MB2 \t052220MB1 \t051820D01 \t060120D01 \t061520MA1 \t062220D02 \t061720MB1 \t052720D02 \t061920E01 \t052120E01",
      "firm_fei_number": "2522600",
      "recalling_firm": "Thomas Scientific",
      "address_1": "1654 High Hill Rd",
      "city": "Swedesboro",
      "state": "NJ",
      "postal_code": "08085-1780",
      "additional_info_contact": "Philip Wikoff\n833-544-7447",
      "reason_for_recall": "The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.",
      "root_cause_description": "No Marketing Application",
      "action": "On 8/31/20, the firm provided FEMA with the recall letter, which was distributed to all affected users. Users were informed that product manufactured and distributed prior to Enforcement Discretion Approval was to be removed. The firm offered to replace any returned product.\n\nTo report and receive replacement, customers should complete the included VTM Product Replacement Form and return it to QC@ThomasSci.com. Thomas Scientific will replace any product that has been returned. Please contact QC@ThomasSci.com for any requests for field support.",
      "product_quantity": "115,800 cs (100 vials/cs)",
      "distribution_pattern": "US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.",
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        "device_name": "Device, Specimen Collection",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2900",
        "device_class": "1"
      }
    }
  ]
}