{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Marlborough",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79424",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "100 Boston Scientific Way",
      "address_2": "N/A",
      "postal_code": "01752-1234",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) in the following: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, including the District of Columbia and Puerto Rico; and countries of: Argentina, Bolivia, Brazil, Canada, Chile, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Peru, Venezuela, Australia, Bangladesh, Botswana, China, Kuwait, Lebanon, Macau, Malaysia, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Turkey, United Arab Emirates, and Zimbabwe.",
      "recall_number": "Z-1103-2018",
      "product_description": "Re-Entry\" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268     The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: \" Antegrade pyelography \" Pressure/perfusion study (Whitaker test) Therapeutic Indications: \" Nephrostomy catheter drainage \" Perfusion chemolysis of renal stones \" Percutaneous nephrolithotomy \" Percutaneous resection and coagulation of urothelial tumors",
      "product_quantity": "2614",
      "reason_for_recall": "Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.",
      "recall_initiation_date": "20171212",
      "center_classification_date": "20180318",
      "termination_date": "20191024",
      "report_date": "20180328",
      "code_info": "Expiration Date Range: 1/14/2018 - 10/9/2021; Batch: 16661359 18712075 20198264  16749367 18773340 20312730  16806828 18833032 20350212  16861193 18876338 20425132  17108329 18932471 20491746  17184858 19066695 20517722  17207012 19157075 20624080  17226842 19235547 20653111  17263721 19389756 20703430  17303885 19468061 20740699  17624941 19515681 20769253  17642196 19596299 20884299  17785597 19879546 20942364  17858548 19962558 20968667  17960226 19992214 20995564  18095912 20017161 21046941  18196369 20065717 21071138  18220028 20119217 21157954  18351957 20169832 21241250  18484526"
    }
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}