{
  "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": "Rancho Santa Margarita",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63100",
      "recalling_firm": "Applied Medical Resources Corp",
      "address_1": "22872 Avenida Empresa # 3",
      "address_2": "N/A",
      "postal_code": "92688-2650",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of  United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.",
      "recall_number": "Z-2446-2012",
      "product_description": "Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX):  Model Numbers & Description:    A4402, 3F-40CM, SYNTEL RT-EMB;  A4403, 3F-80CM, SYNTEL RT-EMB;  A4404, 4F-40CM, SYNTEL RT-EMB;  A4405, 4F-80CM, SYNTEL RT-EMB;  A4406, 5F-80CM, SYNTEL RT-EMB;  A4407, 6F-80CM, SYNTEL RT-EMB;  A4408, 7F-80CM, SYNTEL RT-EMB;  A4F00, 2F-60CM (PREM) SYNTEL CATHETER;  A4F01, 2F-80CM, (PREM) SYNTEL CATHETER;  A4F02, 3F-40CM, (PREM) SYNTEL CATHETER;  A4F03, 3F-80CM, (PREM) SYNTEL CATHETER;  A4F04, 4F-40CM, (PREM) SYNTEL CATHETER;  A4F05, 4F-80CM, (PREM) SYNTEL CATHETER;  A4F06, 5F-80CM, (PREM) SYNTEL CATHETER;  A4F07, 6F-80CM, (PREM) SYNTEL CATHETER;  A4F08, 7F-80CM, (PREM) SYNTEL CATHETER;  CE0260ST, L2F-60CM PREM SYNTEL CATH;  CE0280ST, L2F-80CM PREM SYNTEL CATH;  CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER;  CE0380ST, 3F-80CM PREM SYNTEL CATH;  CE0440ST, 4F-40CM PREM SYNTEL CATH;  CE0480ST, 4F-80CM PREM SYNTEL CATH;  CE0580ST, 5F-80CM PREM SYNTEL CATH;  CE0680ST, 6F-80cm (PREM) SYNTEL CATHETER;  CE0780ST, 7F-80CM PREM SYNTEL CATH;  CE0340, 3F-40cm, SYNTEL RT-EMB;  CE0380, 3F-80cm, SYNTEL RT-EMB;  CE0440, 4F-40cm, SYNTEL RT-EMB;  CE0480, 4F-80cm, SYNTEL RT-EMB;  CE0580, 5F-80cm, SYNTEL RT-EMB;  CE0680, 6F-80cm, SYNTEL RT-EMB;  CE0780, 7F-80cm SYNTEL RT-EMB.    BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.",
      "product_quantity": "40,238 units for all products in Recall Event",
      "reason_for_recall": "Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.",
      "recall_initiation_date": "20120809",
      "center_classification_date": "20120925",
      "termination_date": "20130322",
      "report_date": "20121003",
      "code_info": "Model Numbers: Lot Numbers  A4402:  1157054, 1163804, 1170473.  A4403:  1157060, 1162689, 1166031, 1169109.  A4404:  1160223, 1163803, 1166725, 1171181.  A4405: 1155214, 1157053, 1161472, 1162967, 1164628, 1168912.  A4406: 1155428, 1162945, 1167745, 1170042.  A4407: 1154478, 1162866, 1168604.  A4408:  1163626.  A4F00: 1164152, 1164627, 1168666.  A4F01: 1156256, 1160007, 1163628, 1168231.  A4F02: 1156522, 1161792, 1170399.  A4F03: 1155855, 1157052, 1161793, 1160310, 1159725, 1163215, 1163961, 1167855, 1169632, 1164626, 1165853.  A4F04: 1155427, 1160221, 1161791, 1156935, 1171883, 1169729, 1167751, 1165778, 1163384, 1172598.  A4F05: 1155854, 1154446, 1156936, 1155230, 1161471, 1160222, 1159414, 1161998, 1163216, 1163962, 1167440, 1166463, 1164625, 1165323, 1168911.  A4F06: 1155856, 1154435, 1158624, 1161997, 1164149, 1165777, 1169013.  A4F07: 1171170, 1156271, 1167414, 1164151.  A4F08: 1168855, 1155648.  CE0260ST: 1164307, 1168569.  CE0280ST: 1164351.  CE0340ST: 1164348.  CE0380ST: 1164308, 1164337, 1166033, 1169029, 1166281, 1166032.  CE0440ST: 1164336, 1168610.  CE0480ST: 1164303, 1164302, 1164335, 1164304, 1166468, 1168605, 1166284, 1166283.  CE0580ST: 1164345, 1164346, 1168613.  CE0680ST: 1164330, 1166470.  CE0780ST: 1164354.  CE0340: 1166904.  CE0380: 1164344.  CE0440: 1164347, 1168609.  CE0480: 1164343.  CE0580: 1164349.  CE0680: 1164353  CE0780: 1169926.",
      "more_code_info": ""
    }
  ]
}