{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216284",
      "product_res_number": "Z-0173-2026",
      "event_date_initiated": "2025-09-04",
      "event_date_posted": "2025-10-16",
      "recall_status": "Open, Classified",
      "res_event_number": "97659",
      "product_code": "MLS",
      "product_description": "Medical convenience kits \n\nItem number/ Product description\nAHLD15X\tLABOR DELIVERY PACK - 213387\nAKDV96B\tVAGINAL DELIVERY\nAKDV96B\tVAGINAL DELIVERY\nEVBH28D\tBIRTHING ROOM PACK\nUPVD01K\tVAGINAL DELIVERY PACK",
      "code_info": "AHLD15X\nUDI-DI 191072224767\nLot 8188711\nBag serial no. \n17555039\n17555044\n17555049\n17609166\n17609181;\n\nAKDV96B\nUDI-DI 191072224019\nLot 7311311\nBag serial no.\n47140875\n47141919;\n\nEVBH28D\nUDI-DI 191072239051\nLot 8424611\nBag serial no.\n17754395;\n\nUPVD01K\nUDI-DI 191072238993\nLot 8439111\nBag serial no. \n17682598\nLog 8499211\nBag serial no. \n17742543",
      "firm_fei_number": "3007069947",
      "recalling_firm": "American Contract Systems Inc.",
      "address_1": "1601 Se Gateway Dr Ste 120 1601 Se Gateway Dr",
      "address_2": "Ste 120",
      "city": "Grimes",
      "state": "IA",
      "postal_code": "50111-5223",
      "additional_info_contact": "Marlene Jones\n470-280-4277",
      "reason_for_recall": "Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers.\n\nConsignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.",
      "product_quantity": "32,433 total",
      "distribution_pattern": "US Nationwide distribution in the states of SD, IA, MN, WA, IL.",
      "openfda": {
        "k_number": [
          "K961993",
          "K940518",
          "K960243",
          "K931722",
          "K932216",
          "K936120"
        ],
        "registration_number": [
          "3045816907",
          "1423395",
          "1422634",
          "1055236",
          "3004911384",
          "3005012805",
          "3009888344",
          "3014925393",
          "1047429",
          "1054241",
          "3004111573",
          "1423537",
          "1643817",
          "1921846",
          "3045816902",
          "1928237",
          "1030451",
          "1061124",
          "3015173212",
          "1824619",
          "3004122598",
          "2029015",
          "1018470",
          "9616088",
          "1043214",
          "3010155661",
          "3010166880",
          "3008513424",
          "9612030",
          "3006410968",
          "3004519921",
          "3002834291",
          "3035642068",
          "3005595283",
          "3009203853"
        ],
        "fei_number": [
          "3045816907",
          "3004911384",
          "3005012805",
          "3009888344",
          "3014925393",
          "1047429",
          "1000514656",
          "3004111573",
          "1643817",
          "3002806934",
          "1921846",
          "3005846326",
          "3000717925",
          "3045816902",
          "1928237",
          "1030451",
          "3015173212",
          "1824619",
          "3004122598",
          "1000160458",
          "1000512168",
          "3001236905",
          "1018470",
          "1043214",
          "1000112877",
          "3010155661",
          "3010166880",
          "3002902735",
          "3008513424",
          "3006410968",
          "1000112968",
          "3002834291",
          "3035642068",
          "3005595283",
          "3009203853"
        ],
        "device_name": "Labor And Delivery Kit",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.4530",
        "device_class": "2"
      }
    }
  ]
}