{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216293",
      "product_res_number": "Z-0176-2026",
      "event_date_initiated": "2025-09-04",
      "event_date_posted": "2025-10-16",
      "recall_status": "Open, Classified",
      "res_event_number": "97659",
      "product_code": "OEZ",
      "product_description": "Medical convenience kits \n\nItem Number/Description\nANCV78BC\tHEART PACK - 205947\nHGCV05K\tCV SET UP PACK\nMHPP97AR\tPACEMAKER PACK- 206010\nUDBH37AW\tBASIC HEART PACK - 206044\nUHPP82AH\tPERIPHERAL PACK - 209533\nUICD62AN\tCARDIOVASCUALR SUPPLY (PS 907285)\nUICT16F\t CARDIO THORACIC DRAPE PACK (PS 907284)\nUIVA75I\tVASCULAR PACK",
      "code_info": "ANCV78BB\nUDI-DI 191072214362\nLot 8133811\nBag serial number\n68273380;\n\nANCV78BC\nUDI-DI 191072235169\nLot 8499811\nBag serial numbers\nN/A;\n\nHGCV05K\nUDI-DI 191072212474\nLot 8021411\nBag serial number 68154464;\n\nMHPP97AR\nUDI-DI 191072237446\nLot 8527511\nBag serial number N/A;\n\nUDBH37AW\nUDI-DI 191072235299\nLot 8194311\nBag serial numbers\n68198334\n68198335;\n\nUHPP82AH\nUDI-DI 191072216434\nLot 8112811\nBag serial number\nN/A;\n\nUICD62AN\nUDI-DI 191072200495\nLot 7999011\nBag serial number\nN/A;\n\nUICT16F\nUDI-DI 191072150431\nLot 8000411\nBag serial number\nN/A\nLot 8331311\nBag serial number \n17627819\nLot 8429011\nBag serial number\n17749736;\n\nUIVA75I\nUDI-DI 191072229052\nLot 8056011\nBag serial number N/A;\n\nUIVA75J\nUDI-DI 191072235602\nLot 8422011\nBag serial number 68667536\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": [
          "3012536737",
          "1423537",
          "1423395",
          "3004519921",
          "3002807314",
          "3009888344",
          "3010155661",
          "3005012805",
          "1721676",
          "3013162291",
          "3015053858",
          "1047429",
          "1125782",
          "3024985933",
          "1055236",
          "2124215",
          "1061124",
          "1625425",
          "1043214",
          "3026197444",
          "3033589330",
          "1054241",
          "1724474",
          "1643817",
          "1124841",
          "3018044766",
          "3017987980",
          "3011642792",
          "3011144486",
          "3007289408",
          "3015173212",
          "3002124543",
          "1030451",
          "3015910259",
          "3004122598",
          "1016427",
          "2029015",
          "1319639",
          "1221108",
          "3015225571",
          "1721504",
          "1422634",
          "3009337401",
          "9680794",
          "3018077422",
          "3009203853",
          "3015309643",
          "1123137",
          "3005595283",
          "9616099",
          "3006950086",
          "3035642068",
          "1928237",
          "9616088",
          "3014925393",
          "3004911384",
          "3032507796",
          "3045816902",
          "3004111573",
          "3007329020",
          "3010532612"
        ],
        "fei_number": [
          "3012536737",
          "3003528016",
          "3002807314",
          "3009888344",
          "3010155661",
          "1000138054",
          "3005012805",
          "1000160458",
          "1721676",
          "3013162291",
          "3000717925",
          "3002902735",
          "3015053858",
          "1047429",
          "3024985933",
          "3001236905",
          "1000123180",
          "2124215",
          "1625425",
          "1043214",
          "1000112968",
          "1000514656",
          "3026197444",
          "3033589330",
          "1643817",
          "3018044766",
          "3017987980",
          "3011642792",
          "3011144486",
          "3007289408",
          "3015173212",
          "3002124543",
          "1030451",
          "3015910259",
          "3004122598",
          "1000512168",
          "1016427",
          "3005846326",
          "3003737899",
          "1221108",
          "3015225571",
          "1721504",
          "3009337401",
          "3018077422",
          "3009203853",
          "3015309643",
          "1000112877",
          "3005595283",
          "3035642068",
          "3006950086",
          "3045816902",
          "1928237",
          "3003094851",
          "3014925393",
          "3004911384",
          "3032507796",
          "3000204839",
          "3002975287",
          "3004111573",
          "3007329020",
          "3010532612"
        ],
        "device_name": "Cardiovascular Procedure Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      }
    }
  ]
}