{
  "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-1061-2016",
      "product_description": "RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C    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:18F14A0041  18F14C0003  18F14C0006  18F14C0021  18F14C0026  18F14C0027  18F14C0028  18F14E0039  18F14E0055  18F14E0058  18F14F0035  18F14F0038  18F14F0054  18F14G0057  18F14G0077  18F14H0011  18F15B0023  18F15C0001  18F15C0008  18F15C0026  18F15D0028  18F15F0027  18F15F0037  18F15G0003  18F15G0011  18F15G0032  18F15H0046  18F15M0009"
    }
  ]
}