{
  "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": [
    {
      "status": "Terminated",
      "city": "Everett",
      "state": "MA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73266",
      "recalling_firm": "Arrow International, Inc., Division of Teleflex Medical Inc.",
      "address_1": "9 Plymouth St",
      "address_2": "N/A",
      "postal_code": "02149-1814",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).",
      "recall_number": "Z-1058-2016",
      "product_description": "Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U    The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.",
      "product_quantity": "13,405 US and 33,735 OUS in total",
      "reason_for_recall": "The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.",
      "recall_initiation_date": "20160210",
      "center_classification_date": "20160310",
      "termination_date": "20210512",
      "report_date": "20160316",
      "code_info": "Batch: 18F14B0044  18F14B0045  18F14E0060  18F14F0019  18F14G0067  18F14H0002  18F14J0026  18F15A0033  18F15B0009  18F15B0019  18F15C0012  18F15D0016  18F15D0037  18F15D0044  18F15F0001"
    }
  ]
}