{
  "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,
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  },
  "results": [
    {
      "country": "United States",
      "city": "Reading",
      "address_1": "2400 Bernville Rd",
      "reason_for_recall": "Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.",
      "address_2": "",
      "product_quantity": "",
      "code_info": "Lot Numbers: (1) 13F17C0208, 13F17F0162; (2) 13F17F0231; (3) 13F17E0382, 13F17F0206; (4) 13F17D0049; (5) 13F17A0052, 13F17C0390; (6) 13F17A0123, 13F17E0014, 13F17E0455, 13F17F0289; (7) 13F16M0274, 13F17E0040, 13F17E0227, 13F17E0824",
      "center_classification_date": "20180410",
      "distribution_pattern": "Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.",
      "state": "PA",
      "product_description": "(1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with  7.5 - 8 Fr. Catheters, Part Number: ASK-09803-WBH1; (2) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09903-KH; (3) Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr.  Catheters, Part Number: ASK-09903-LC; (4) PSI Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09903-PHP; (5) Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09907-LGH1; (6) Arrow PSI Kit, Part Number: CDC-09803-1A; (7) Arrow PSI Kit, Part Number: CDC-09903-1A",
      "report_date": "20180418",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Arrow International Inc",
      "recall_number": "Z-1329-2018",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "79512",
      "termination_date": "20200527",
      "more_code_info": "",
      "recall_initiation_date": "20171222",
      "postal_code": "19605-9607",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}