{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Irvine",
      "address_1": "1 Edwards Way",
      "reason_for_recall": "Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.",
      "address_2": "",
      "product_quantity": "13,077 (U.S.) and 12,306 (International)",
      "code_info": "Model #           Lot #       Expiration Date  PX2X3 59987950 3/12/2017  PX2X3 60008882 3/24/2017  PX2X3 60043561 5/1/2017  PX3X3272 59994227 3/8/2017  PX3X3272 60025936 4/15/2017  PX3X3AN 60030889 4/17/2017  PX3X3AN 60008883 3/26/2017  PXAK2066 60025499 2/27/2017  PXAVMP3 60036757 4/27/2017  PXMK1970 60001398 4/16/2017  PXMK2043 59994210 3/9/2017  PXMK2043 60001412 3/17/2017  PXMK2043 60020166 4/5/2017  PXMK2043 60030868 4/26/2017  PXMK2144 60019038 4/17/2017  PXMK2217 59994267 3/12/2017  PXMK2217 60030969 4/20/2017  PXMK2217 60020235 4/15/2017  PXVK0458 59983333 4/6/2017  PXVK1079 59994195 3/11/2017  PXVK1079 60020153 3/31/2017  PXVMP2X31 59998630 3/12/2017  PXVMP2X31 59999004 3/13/2017  PXVMP2X31 59999006 3/13/2017  PXVMP3X31 59994223 3/13/2017  PXVMP3X31 60049581 4/23/2017  PXVMP3X32 60025874 3/31/2017  T001746A 60036771 4/30/2017  T001759A 59976102 3/10/2017  T001759A 60014134 3/31/2017  T001759A 60020177 4/13/2017  T001759A 60049570 5/4/2017  T330V11A 60014160 3/29/2017  T333F00A 59987991 3/9/2017  T333F00A 60001468 3/16/2017  T333F00A 60022033 3/13/2017  T334041A 60008925 3/25/2017  T334041A 60049612 5/5/2017  T336547B 60008919 3/27/2017  T337305B 59987992 3/11/2017  T337305B 60001473 3/17/2017  T391314A 60020222 3/29/2017  T391T01A 60014163 3/30/2017  T395606B 60022034 3/13/2017  T395606B 60025971 4/14/2017  T430140A 60014177 3/31/2017  T430609A 60001486 3/16/2017  T430609A 60043616 4/27/2017  T431305A 60008942 3/25/2017  T431305A 60059909 5/8/2017  T440B20B 59994257 3/13/2017  T440B20B 60030953 4/17/2017  T440B21A 60025987 4/15/2017  T440B21A 59976182 3/11/2017  T440B26B 60030938 4/17/2017  T440B26B 60049616 5/4/2017  T443422A 60036750 4/29/2017  T443422A 60020223 4/15/2017  T449103B 60008929 3/24/2017  T449103B 60043599 4/28/2017  T450544A 60030944 4/20/2017  T494C00B 60020168 3/19/2017  T494C00B 60001415 3/25/2017  T494C00B 60043543 4/21/2017  T530116B 60022035 3/13/2017  T530116B 60008937 3/24/2017",
      "center_classification_date": "20150916",
      "distribution_pattern": "Worldwide Distribution - US nationwide, Australia, Austria, Canada, China, Colombia, Croatia, Denmark, France, Germany, Great Britain, Italy, Netherlands, New Zealand, Sweden, and Slovenia.",
      "state": "CA",
      "product_description": "Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer.  A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.",
      "report_date": "20150923",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Edward Lifesciences, Llc",
      "recall_number": "Z-2776-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "71971",
      "termination_date": "20160708",
      "more_code_info": "",
      "recall_initiation_date": "20150731",
      "postal_code": "92614-5688",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}