{
  "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-1057-2016",
      "product_description": "FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS    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: 18F14A0025  18F14A0026  18F14A0030  18F14A0049  18F14A0050  18F14A0051  18F14A0054  18F14A0057  18F14A0066  18F14A0067  18F14D0045  18F14E0004  18F14E0006  18F14E0016  18F14E0017  18F14E0052  18F14F0017  18F14F0047  18F14F0049  18F14F0080  18F14G0003  18F14G0004  18F14G0021  18F14G0037  18F14G0055  18F14G0056  18F14G0068  18F14G0070  18F14G0071  18F14G0076  18F14H0009  18F14H0030  18F14H0054  18F14H0055  18F14H0060  18F14H0061  18F14J0003  18F14J0005  18F14J0037  18F14K0006  18F14M0001  18F14M0014  18F14M0032  18F15A0005  18F15A0011  18F15A0026  18F15A0034  18F15B0005  18F15B0008  18F15B0010  18F15B0018  18F15B0020  18F15B0027  18F15C0002  18F15C0007  18F15C0010  18F15C0015  18F15C0024  18F15C0030  18F15C0036  18F15D0017  18F15D0032  18F15D0034  18F15D0043  18F15D0049  18F15E0003  18F15E0011  18F15E0014  18F15E0023  18F15E0029  18F15E0037  18F15F0011  18F15F0017  18F15F0021  18F15F0032  18F15G0001  18F15G0013  18F15G0021  18F15G0028  18F15G0034  18F15H0010  18F15H0015  18F15H0021  18F15H0024  18F15H0033  18F15J0013  18F15J0028  18F15J0038  18F15J0044  18F15J0049  18F15K0001  18F15K0007  18F15L0002  18S14G0068  18S14M0001  18S15C0002"
    }
  ]
}