{
  "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": "2026-10-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "222519",
      "product_res_number": "Z-0107-2027",
      "event_date_initiated": "2026-08-25",
      "event_date_posted": "2026-10-07",
      "recall_status": "Open, Classified",
      "res_event_number": "99810",
      "product_code": "JPH",
      "k_numbers": [
        "K840500"
      ],
      "product_description": "SEDIPLAST;\r\nModel/Catalog Numbers: S-100 and S-1000;",
      "code_info": "Model/Catalog No. S-100 and S-1000; \nUDI-DI: N/A;\nLot Number E1150A; \nExpiration Date 06/30/27",
      "firm_fei_number": "1000119795",
      "recalling_firm": "POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC",
      "address_1": "510 Furnace Dock Rd",
      "city": "Cortlandt Manor",
      "state": "NY",
      "postal_code": "10567-6220",
      "additional_info_contact": "Mariah Nieves\n+1-914-2930924",
      "reason_for_recall": "During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting in the release of blood and exposure of the operator or surrounding work area to a biological hazard (blood).",
      "root_cause_description": "Process control",
      "action": "On August 26, 2026, URGENT PRODUCT RECALL letters were sent to customers.\nACTIONS REQUIRED:\n1. Examine your inventory and identify all Sediplast Westergren ESR tubes from Lot E1150A.\n2. Immediately discontinue use and quarantine all unused tubes from the affected lot.\n3. If affected product was distributed to other facilities or locations, immediately forward this notification to those recipients.\n4. Contact Polymedco Technical Services to arrange replacement of the affected product and obtain instructions for its return or disposal.\n5. Complete and return the enclosed Customer Recall Response Form to Polymedco within five business days, even if you no longer have any affected product in inventory.\n6. If affected tubes were previously used without an incident, no additional action is required. If a cap-ejection, blood-spray or exposure incident occurred, follow your facility s applicable biohazard-exposure procedures and report the incident to Polymedco Technical Services.\nPlease do not discard quarantined product until you have received return or disposal instructions from Polymedco.",
      "product_quantity": "448400",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states and territory of AK, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the country of United Kingdom.",
      "openfda": {
        "k_number": [
          "K823761",
          "K852554",
          "K831195",
          "K840500",
          "K871076",
          "K860899",
          "K823368"
        ],
        "registration_number": [
          "3024820199",
          "3029895090",
          "3010280735",
          "9615056",
          "3010352064",
          "9614769",
          "2435505",
          "3018126397",
          "9617475",
          "1950302",
          "2244900",
          "3011287770",
          "3010194621"
        ],
        "fei_number": [
          "3024820199",
          "3029895090",
          "3010280735",
          "3010352064",
          "3018126397",
          "1000119795",
          "3002808075",
          "1950302",
          "2244900",
          "3011287770",
          "3002807499",
          "1000186023",
          "3010194621"
        ],
        "device_name": "Test, Erythrocyte Sedimentation Rate",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.6700",
        "device_class": "1"
      }
    }
  ]
}