{
  "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": [
    {
      "country": "United States",
      "city": "Minneapolis",
      "address_1": "2300 Berkshire Ln N",
      "reason_for_recall": "Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set.",
      "address_2": "",
      "product_quantity": "6,642 sets (66,420 devices)",
      "code_info": "W1190519  W1190532  W1190532  W1190514  W1190517  W1190517  W1190516  W1266849  W1266851  W1266850  W1266848  W1298418  W1300005  W1298419  W1298425  W1298426  W1362771  W1362772  W1362773  W1362775  W1383678  W1362774  W1420240  W1420241  W1420242  W1434887  W1434888  W1464513  W1464514  W1464516  W1464511  W1464512  W1464515  W1466090  W1466092  W1466093  W1466091  W1467421  W1477933  W1467420  W1477935  W1477932  W1477934  W1490379  W1477937  W1490378  W1490380  W1490377  W1477936  W1509174  W1509175  W1532502  W1532501  W1509173  W1599234  W1629461  W1661254  W1688745  W1720426  W1746962  W1720428  W1792523  W1786461  W1788967  W1770099  W1807382  W1807383  W1807378  W1872468  W1872469  W1872470  W1927797  W1872468  W1927798  W1927799  W1963380  W2012849  W2012851  W2012850  W2047027  W2058073  W2047028  W2073401  W2047030  W2047031  W2094903  W2110798  W2170053  W2155950  W2170050  W2170052  W2192990  W2211695  W2211696  W2211697  W2268277  W2268271  W2315849  W2315850  W2315845  W2315846  W2315848  W2357893  W2357894  W2371770  W2371771  W2392043  W2357895  W2357896  W2397846  W2371772  W2386295  W2451688  W2451690  W2451691  W2451692  W2451693  W2461057  W2461056  W2461058  W2513845  W2561761  W2561762",
      "center_classification_date": "20140513",
      "distribution_pattern": "US Nationwide Distribution in the state of UT.",
      "state": "MN",
      "product_description": "Coaxial Micro-Introducer Kit.    Greatbatch Part Number/Bard Access Systems Order Number/Part Description    10636-001  8004011  Kit Coax 10 Pack 4FR Bard    10636-002  8005011  Kit Coax 10 Pack 5FR Bard    10636-007  8004012  Kit Coax 10 Pack 4FR Bard    10636-008  8005012  Kit Coax 10 Pack 5FR Bard    10636-009  8004022  Kit Coax 10 Pack 5FR Bard    10636-010  8005022  Kit Coax 10 Pack 5FR Bard    The Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle, 0.018 inch floppy tip guidewire, and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The Coaxial Micro-Introducer Set is used to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick.",
      "report_date": "20140521",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Greatbatch Medical",
      "recall_number": "Z-1614-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "68161",
      "termination_date": "20160524",
      "more_code_info": "",
      "recall_initiation_date": "20140428",
      "postal_code": "55441-4575",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}