{
  "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": "2026-04-29",
    "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": "69938",
      "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 -- US and Canada.",
      "recall_number": "Z-1007-2015",
      "product_description": "The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-15312-SFX, AC-15422-SFX, CS-15192-SFX, CS-15192-SFXM, CS-15232-SFX, CS-15242-I, CS-15272-SFX, CS-15282-I, CS-15312-SFX, CS-15322-I, CS-15362-I, CS-15422-SFX, CS-15502-SFX, CS-15552-I, CSD-15242-I, CSD-15282-I, and CSD-15322-I.     The Arrow Edge Hemodialysis Catheterization Set and NextStep Antegrade Hemodialysis Catheterization Set is indicated for use in attaining long- term vascular access for hemodialysis and apheresis.",
      "product_quantity": "2,480",
      "reason_for_recall": "The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause  a delay in treatment for the time it takes to retrieve a replacement kit.",
      "recall_initiation_date": "20130204",
      "center_classification_date": "20150122",
      "termination_date": "20161014",
      "report_date": "20150128",
      "code_info": "Lot numbers: RF2095946, RF2056557, RF2058764, RF2060829,   RF2084897, RF2084162, RF2071325,RF2060831, RF2083836, RF2096027, RF2107409, RF2108329, RF2119933, RF2060836, RF2060899, RF2083837,   RF2084898, RF2107410, RF2108324, RF2071317, RF2121827, RF2058355,   RF2060414, RF2108326, RF2060811, RF2110441, RF2069798, RF2121821,   RF2069964, RF2122497, RF2110442, RF2058357, RF2119935, RF2108330,   RF2121820, RF2057719, RF2056545, RF2111259, RF2096348."
    }
  ]
}