{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Reading",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "64593",
      "recalling_firm": "Arrow International Inc",
      "address_1": "2400 Bernville Road",
      "address_2": "N/A",
      "postal_code": "19605",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA including Puerto Rico and the states of  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. and the countries of  Australia, Dominican Republic, Uruguay, Ecuador, Chile, Taiwan, Pakistan, Colombia, Argentina, Korea Republic, New Zealand, Guatemala, Thailand, Peru, Bahamas, Philippines, Trinidad and Tobago, Japan, Ireland, India, Singapore, China, Canada and Mexico.",
      "recall_number": "Z-1057-2013",
      "product_description": "Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter.    The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be sued to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart. The Arrow Berman(TM) Angiographic Catheter is also indicated for use in Balloon Occlusion Femoral Angiography (BOFA) of the ipsilateral leg for adult patients. The Arrow Reverse Berman(TM) Angiographic Catheter is indicated for balloon occlusion pulmonary angiography.",
      "product_quantity": "99627ea",
      "reason_for_recall": "The product specifications sheet, part of the Instructions for Use (IFU), for the specified product numbers, reference Renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer available.  Firm is in the process of updating the labeling for these products.  In the meantime, when choosing an alternative contrast medium, health care providers are instructed to select a contrast",
      "recall_initiation_date": "20130304",
      "center_classification_date": "20130404",
      "termination_date": "20131221",
      "report_date": "20130410",
      "code_info": "Part Numbers --AI-07035, AI-07131, AI-07135, AI-07037, AI-07132, AI-07136, AI-07130, AI-07133, AI-07137, AI-07130-J, AI-07134, AND AI-07138."
    }
  ]
}