{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "211209",
      "product_res_number": "Z-0732-2025",
      "event_date_initiated": "2024-11-06",
      "event_date_posted": "2024-12-20",
      "recall_status": "Open, Classified",
      "res_event_number": "95707",
      "product_code": "MAV",
      "k_numbers": [
        "K961471"
      ],
      "product_description": "20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.",
      "code_info": "UDI-DI: 08717648013973, Lots: 60516923, 60553232, 60553233, 60556003, 60556008, 60556009, 60556011, 60556012, 60556014, 60557297, 60559370, 60559371, 60559374, 60559375, 60559376, 60561751, 60561752, 60561753, 60561754, 60561755",
      "firm_fei_number": "2024168",
      "recalling_firm": "Abbott Vascular Inc",
      "address_1": "26531 Ynez Rd",
      "city": "Temecula",
      "state": "CA",
      "postal_code": "92591-4630",
      "additional_info_contact": "Alicia Swanson\n408-845-3427",
      "reason_for_recall": "Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.",
      "root_cause_description": "Component change control",
      "action": "On 11/6/2024, recall notices were distributed to customers asking them to take the following actions:\n\n1) Stop using affected devices.\n2) Complete and return the acknowledgement form.\n3) Return unused devices to the firm.\n4) Share this notification with relevant personnel in your organization.\n5) If you have further distributed/transferred the affected products, notify those customers.\n\nIf you have any questions contact firm customer service at 800-227-9902",
      "product_quantity": "23,407",
      "distribution_pattern": "US: IA, MD, DC, IN, CA, NV, TX, CT, GA, MS, NY, OH, FL, NC, MI, KY, PA, VA, IL, OK, TN, UT, WA, WI, MT, OR, LA, HI, NE, AR, MO, MA, KS, ID, AL, AZ, PR, CO, SC.\n\nOUS: IN, KR, SG, TH, VN, AR, BR, CA, CO, PA, UY, BE, CZ, DE, ES, FR, GB, IT, PT, RE, SE, SK, TM, JP.",
      "openfda": {
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          "K082755",
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          "K143522",
          "K895511",
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          "K993341",
          "K853136",
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        "registration_number": [
          "2011171",
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          "3014579161",
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          "3005941719",
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        "fei_number": [
          "1000117748",
          "1000138054",
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        ],
        "device_name": "Syringe, Balloon Inflation",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1650",
        "device_class": "2"
      }
    }
  ]
}