{
  "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-1060-2016",
      "product_description": "UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-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:18F13M0017  18F13M0019  18F13M0021  18F14A0012  18F14A0013  18F14A0015  18F14A0016  18F14A0044  18F14A0047  18F14B0042  18F14B0043  18F14D0068  18F14E0005  18F14E0007  18F14E0031  18F14E0053  18F14E0069  18F14F0030  18F14F0031  18F14F0066  18F14G0020  18F14G0039  18F14G0066  18F14H0003  18F14H0010  18F14H0023  18F14H0024  18F14H0056  18F14J0006  18F14J0016  18F14J0027  18F14J0051  18F15A0008  18F15A0015  18F15A0023  18F15B0003  18F15B0007  18F15B0021  18F15C0006  18F15C0011  18F15C0027  18F15D0010  18F15D0019  18F15D0045  18F15E0002  18F15E0012  18F15F0008  18F15F0028  18F15F0038  18F15F0041  18F15G0016  18F15G0027  18F15H0005  18F15H0020  18F15H0032  18F15H0041  18F15J0007  18F15J0010  18F15J0021  18F15J0029  18F15J0039  18F15J0056  18F15K0016  18F15K0032  18F15L0001  18F15L0010"
    }
  ]
}