{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87993",
      "recalling_firm": "Edwards Lifesciences, LLC",
      "address_1": "1 Edwards Way",
      "address_2": "N/A",
      "postal_code": "92614-5688",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: AZ  CA  CO  CT  DC  DE  FL  GA  ID  IL  IN  KY  LA  MA  MD  ME  MI  MN  MO  MS  MT  NC  ND  NE  NJ  PR  SD  TX  UT  VA  WA  WI  WV    OUS: Canada, United Kingdom, Italy",
      "recall_number": "Z-1959-2021",
      "product_description": "Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507",
      "product_quantity": "460 units",
      "reason_for_recall": "There is a potential that the pressure tubing may detach from the blood sampling system",
      "recall_initiation_date": "20210526",
      "center_classification_date": "20210625",
      "termination_date": "20231214",
      "report_date": "20210707",
      "code_info": "Lot #s: 63505216 and 63590087"
    }
  ]
}