{
  "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": "Saint Paul",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "65732",
      "recalling_firm": "Medtronic Inc. Cardiac Rhythm Disease Management",
      "address_1": "8200 Coral Sea St NE",
      "address_2": "",
      "postal_code": "55112-4391",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Worldwide Distribution - US Distribution only to MS and IL, and the countries of  Argentina, South Africa and Singapore.",
      "recall_number": "Z-1966-2013",
      "product_description": "Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide.      Recall Update 9/6/13: Medtronic, Red cross Infant Pack 1/B, South-Africa,  REF M272403C, Sterile EO.    The Affinity Pediatric Arterial Filters are single-use, sterile, nonpyrogenic devices designed to filter microemboli greater than the specified micron size from the circuit for periods up to 6 hours during cardiopulmonary bypass surgery.  These devices are available both in an uncoated and a Carmeda coated option.  The Carmeda coating is a BioActive surface that is non-leaching and provides a thromboresistant blood contact surface.",
      "product_quantity": "153 devices.",
      "reason_for_recall": "Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the filter media that may allow unwanted particulate or gaseous emboli to pass through the filter and the outlet of the device, which could result in serious injury to a pediatric patient including neurological damage, or potential patient death.",
      "recall_initiation_date": "20130614",
      "center_classification_date": "20130814",
      "termination_date": "20140307",
      "report_date": "20130821",
      "code_info": "Lot Numbers:  12635577 and 12637041  Updated infrormation on 9/6/13 to include Lot # 12645672",
      "more_code_info": ""
    }
  ]
}