{
  "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": "216291",
      "product_res_number": "Z-0175-2026",
      "event_date_initiated": "2025-09-04",
      "event_date_posted": "2025-10-16",
      "recall_status": "Open, Classified",
      "res_event_number": "97659",
      "product_code": "OES",
      "product_description": "Medical convenience kits \n\nItem Number/Description\nEVLH67F\tLEFT HEART CATH PACK\nFDCL22R\tCATH LAB ANGIO\nIHCC03X\tCATH CARDIAC PACK\nTNCC02AD\tCARDIAC CATH TRINITY\nUICC27AG\tCARDIAC CATH ANGIO PACK (PS 923077)\nUIRD89AH\tRADIAL PACK (PS 56573)",
      "code_info": "AMCL05P\nUDI-DI 191072207296\nLot 7990011\nBag serial no.\nN/A\nLot 8170111\nBag serial numbers\n68194152\n68194153\n68194160\n68194176\n68194179\n68194182\n68194190\nLot 8526511\nBag serial numbers\n68873157\n68874410;\n\nEVLH67F\nUDI-DI 191072232380\nLot 8211011\nBag serial number N/A\nLot 8367311\nBag serial number\n68570438;\n\nFDCL22R\nUDI-DI 191072185259\nLot 8048511\nBag serial numbers\n68045373\n68045376;\n\nIHCC03X\nUDI-DI 191072226273\nLot 80111\nBag serial number N/A\nLot 8085711\nBag serial numbers\n47506640\n47506761;\n\nTNCC02AD\nUDI-DI 191072212757\nLot 7970911\nBag serial number N/A\nLot 8045911\nBag serial number \n47503192\nLot 8426711\nBag serial number 47886615;\n\nUICC27AG\nUDI-DI 191072231307\nLot 8085511\nBag serial number N/A\nLot 8167611\nBag serial number 68194108;\n\nUIRD89AH\nUDI-DI 191072231314\nLot 8068111\nBag serial number\n47499672\n47499908\n\n* if Bag serial number is \"n/a\", then all of that lot is affected",
      "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": {
        "registration_number": [
          "3045816907",
          "1423395",
          "1422634",
          "3007329020",
          "3004911384",
          "9680794",
          "3005012805",
          "3009888344",
          "9616099",
          "1047429",
          "3011144486",
          "3004111573",
          "1423537",
          "1643817",
          "3045816902",
          "1928237",
          "3011137372",
          "1030451",
          "3015173212",
          "1061124",
          "1824619",
          "1016427",
          "3004122598",
          "2029015",
          "1018470",
          "9616088",
          "3008513424",
          "3004519921",
          "3035642068",
          "3005595283",
          "3010532612"
        ],
        "fei_number": [
          "3045816907",
          "3007329020",
          "3004911384",
          "3005012805",
          "3009888344",
          "1047429",
          "3011144486",
          "1000514656",
          "3004111573",
          "1643817",
          "3005846326",
          "3000717925",
          "3010532612",
          "3045816902",
          "1928237",
          "1030451",
          "3015173212",
          "1824619",
          "1016427",
          "3004122598",
          "1000160458",
          "1000512168",
          "3001236905",
          "1018470",
          "3003528016",
          "3002902735",
          "3008513424",
          "3035642068",
          "3005595283",
          "3003737899",
          "3005747797"
        ],
        "device_name": "Cardiac Catheterization Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      }
    }
  ]
}