{
  "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": "Covington",
      "state": "GA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82450",
      "recalling_firm": "Bard Medical Division",
      "address_1": "8195 Industrial Blvd NE",
      "address_2": "N/A",
      "postal_code": "30014-1497",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of  Argentina, Australia, Canada, Saudi Arabia, South Korea, Singapore, Thailand, and Chile",
      "recall_number": "Z-1241-2019",
      "product_description": "Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads:  Description, Catalog Number  a) Intrepid ArcticGel Small Pad Kit, 31705I  b) Intrepid ArcticGel Medium Pad Kit, 31707I  c) Intrepid ArcticGel Large Pad Kit, 31709I  d) Intrepid ArcticGel Universal Pad, 31700I  e) ArcticGel Universal Pad, 31700  f) ArcticGel Universal Pad, 4-pack, 3170004  g) ArcticGel X-Small Pad, 31703  h) ArcticGel X-Small Pad, 2-pack, 3170302  i) ArcticGel Small Pad Kit, 31705  j) ArcticGel Small Pad Kit, 2-pack, 3170502  k) ArcticGel Medium Pad Kit, 31707  l) ArcticGel Medium Pad Kit, 2-pack, 3170702  m) ArcticGel Large Pad Kit, 31709  n) ArcticGel Large Pad Kit, 2-pack, 3170902  o) ArcticGel Small Universal Pad Kit, 31810  p) ArcticGel Small Universal Pad,4-pack, 3180104  q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only)  r) Intrepid ArcticGel Small Pad Kit, 31705I    Product Usage:  The Arctic Sun¿ Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature. ArcticGel Pads are used with the Arctic Sun¿ Temperature Management System to provide a hydrogel layer that ensures contact between the patient s skin and the pad throughout the treatment.",
      "product_quantity": "7526 units",
      "reason_for_recall": "Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the hydrogel to the pad.",
      "recall_initiation_date": "20171108",
      "center_classification_date": "20190426",
      "termination_date": "20200902",
      "report_date": "20190508",
      "code_info": "Catalog Number / lot number  a) Intrepid ArcticGel Small Pad Kit, 31705I / NGAXY602  b) Intrepid ArcticGel Medium Pad Kit, 31707I / NGAXY603  c) Intrepid ArcticGel Large Pad Kit, 31709I / NGAXY604  d) Intrepid ArcticGel Universal Pad, 31700I / NGAXY601  e) ArcticGel Universal Pad, 31700 / NGAW3898, NGAW3055, NGAZ3417, NGBP1302, NGBP2293, NGBQ1040  f) ArcticGel Universal Pad, 4-pack, 3170004 / NGAW2916, NGAW3893, NGAZ3735, NGBP2294, NGBQ1021  g) ArcticGel X-Small Pad, 31703 /   h) ArcticGel X-Small Pad, 2-pack, 3170302 / NGBP0392, NGBN3519  i) ArcticGel Small Pad Kit, 31705 / NGAW3894, NGAW4510, NGAZ2312, NGAZ3312, NGBN2492, NGBP0513  j) ArcticGel Small Pad Kit, 2-pack, 3170502 / NGAW3900, NGAW3059, NGAY4735, NGAZ0554, NGBP0514, NGBP4515  k) ArcticGel Medium Pad Kit, 31707 / NGBN3536, NGBP0512  l) ArcticGel Medium Pad Kit, 2-pack, 3170702 / NGBN3521  m) ArcticGel Large Pad Kit, 31709 /   n) ArcticGel Large Pad Kit, 2-pack, 3170902 /   o) ArcticGel Small Universal Pad Kit, 31810 / NGBP1534  p) ArcticGel Small Universal Pad,4-pack, 3180104 / NGBP1533, NGBP2320  q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only) / NGBP3712  r) ArcticGel Neonatal Pad, 2-pack, 3180202 / NGBP0393"
    }
  ]
}