{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "220829",
      "product_res_number": "Z-2400-2026",
      "event_date_initiated": "2026-05-27",
      "event_date_posted": "2026-06-10",
      "recall_status": "Open, Classified",
      "res_event_number": "99105",
      "product_code": "MVL",
      "k_numbers": [
        "K190220"
      ],
      "product_description": "Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit,\nCatalog number 504600-28",
      "code_info": "Model No. 504600-28; UDI-DI 00371347008104; Lot Number 2026-0204",
      "firm_fei_number": "3000209941",
      "recalling_firm": "Inter-Med Llc",
      "address_1": "2200 South St",
      "city": "Racine",
      "state": "WI",
      "postal_code": "53404-1510",
      "additional_info_contact": "Alex Johnson\n201-569-0050",
      "reason_for_recall": "Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of ingestion, while the correct Aluminum Chloride insert instructs users not to induce vomiting.",
      "root_cause_description": "Labeling mix-ups",
      "action": "On 5/27/2026, firm notified consignees via email. \n\nConsignees were instructed to return all units from Lot 2026-0204 to Inter-Med, Inc.\n\nInter-Med, Inc. will provide prepaid return shipping labels. All returned product will be replaced with correctly packaged product at no charge, or a credit may be issued at the customer's preference. Customers must also notify any downstream dental practices or end users who received product from this lot and instruct them to return product.",
      "product_quantity": "500",
      "distribution_pattern": "US Nationwide distribution in the states of Tennessee and Missouri.",
      "openfda": {
        "k_number": [
          "K200764",
          "K093721",
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          "K254239",
          "K041023",
          "K162948",
          "K050180",
          "K131799",
          "K111978",
          "K130580",
          "K171577",
          "K082116",
          "K152064",
          "K162662",
          "K123215",
          "K113839",
          "K253797",
          "K083695",
          "K162164",
          "K981596",
          "K211420",
          "K053329",
          "K213149",
          "K111348",
          "K190220",
          "K093711",
          "K010070",
          "K132526",
          "K243910",
          "K162536"
        ],
        "registration_number": [
          "3045857207",
          "3012058545",
          "2515379",
          "3007113445",
          "3013298431",
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          "8010629",
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          "9611385",
          "1941138",
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          "2243757",
          "9610902"
        ],
        "fei_number": [
          "3045857207",
          "3012058545",
          "1000231788",
          "2515379",
          "3007113445",
          "3013298431",
          "1281412",
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          "3001421500",
          "3003677417",
          "3002807166",
          "1000477999",
          "3000209941",
          "3007743883",
          "3013584861",
          "3038718579",
          "2513595",
          "3043226252",
          "2511556",
          "3002718942",
          "3002806930",
          "3000368601",
          "2024312",
          "2183301",
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          "1000272892",
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          "2014676",
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          "3044819802",
          "3011689956",
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          "3008912871",
          "3035693034",
          "1941138",
          "3001180585",
          "1718912",
          "2243757"
        ],
        "device_name": "Cord, Retraction",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U"
      }
    }
  ]
}