{
  "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": "221147",
      "product_res_number": "Z-2772-2026",
      "event_date_initiated": "2026-05-19",
      "event_date_posted": "2026-07-22",
      "recall_status": "Open, Classified",
      "res_event_number": "99250",
      "product_code": "OES",
      "product_description": "Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. \n\nConvenience kit.",
      "code_info": "Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026).",
      "firm_fei_number": "1047429",
      "recalling_firm": "AVID Medical, Inc.",
      "address_1": "9000 Westmont Dr",
      "city": "Toano",
      "state": "VA",
      "postal_code": "23168-9351",
      "additional_info_contact": "Marlene Jones\n757-566-3510",
      "reason_for_recall": "Defects in the silicone seal, which may result in \"doming\" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.",
      "root_cause_description": "Process change control",
      "action": "AVID Medical notified consignees on about 05/19/2026 via email. Consignees were instructed to identify, segregate, and quarantine all impacted kits, and add the provided warning labels to affected AVID kits to ensure all users are aware of discarding the impacted component prior to use. Distributors were instructed to ensure all end-users are properly notified if affected kits have been further distributed. Customers/End-users were instructed that if they have received product from a distributor, to contact the distributor or your sales representative with any questions. Recipients were requested to complete and return the provided Recall Response Form.",
      "product_quantity": "112 kits",
      "distribution_pattern": "U.S. Nationwide distribution in the state of California.",
      "openfda": {
        "registration_number": [
          "3010532612",
          "3007329020",
          "3011137372",
          "3008513424",
          "1643817",
          "3045816907",
          "1423537",
          "1061124",
          "9680794",
          "3009888344",
          "3004122598",
          "3005012805",
          "3011144486",
          "9616099",
          "1824619",
          "3004111573",
          "3004519921",
          "3035642068",
          "1018470",
          "1422634",
          "9616088",
          "3015173212",
          "2029015",
          "3004911384",
          "1928237",
          "3005595283",
          "3045816902",
          "1047429",
          "1423395",
          "1030451",
          "1016427"
        ],
        "fei_number": [
          "3010532612",
          "3007329020",
          "3008513424",
          "1643817",
          "3045816907",
          "3005747797",
          "3009888344",
          "3004122598",
          "3005012805",
          "3011144486",
          "3000717925",
          "1824619",
          "1000514656",
          "3004111573",
          "3035642068",
          "1018470",
          "3005846326",
          "1000160458",
          "3015173212",
          "3003737899",
          "3004911384",
          "3001236905",
          "3003528016",
          "1928237",
          "3005595283",
          "3045816902",
          "1047429",
          "1000512168",
          "1030451",
          "1016427",
          "3002902735"
        ],
        "device_name": "Cardiac Catheterization Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      }
    }
  ]
}