{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
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  },
  "results": [
    {
      "cfres_id": "185850",
      "product_res_number": "Z-1257-2021",
      "event_date_initiated": "2021-02-11",
      "event_date_created": "2021-03-15",
      "recall_status": "Completed",
      "res_event_number": "87329",
      "product_code": "NIM",
      "pma_numbers": [
        "P030047"
      ],
      "product_description": "PRECISE PRO RX CAROTID STENT implant system, Product Codes:  PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC",
      "code_info": "1.\tPC0520RXC, Lot Numbers:  17917082, 17925698, 17945241, 17946961 2.\tPC0530RXC, Lot Numbers:  17907242, 17915157, 17931757, 17936915, 17940306, 17945490, 17950283, 17952939 3.\tPC0540RXC, Lot Numbers:  17907243, 17911879, 17920422, 17931758, 17942800, 17945242, 17947078, 17950284, 17955963, 17960311 4.\tPC0620RXC, Lot Numbers:  17917084, 17920423, 17931102, 17949017, 17955964 5.\tPC0630RXC, Lot Numbers:  17910548, 17914196, 17915158, 17921807, 17937805, 17939529, 17945243, 17945883, 17949018, 17957289   6.\tPC0640RXC, Lot Numbers:  17903563, 17908608, 17912281, 17916478, 17928282, 17934629, 17936243, 17939530, 17946675, 17950285, 17958864, 17961560  7.\tPC0720RXC, Lot Numbers:  17929124, 17933386 8.\tPC0730RXC, Lot Numbers:  17909814, 17916479, 17925699, 17929770, 17935168, 17940238, 17941419, 17949346, 17951255, 17951944, 17954156, 17959599  9.\tPC0740RXC, Lot Numbers:  17905295, 17915162, 17920425, 17922174, 17926320, 17935169, 17936920, 17937807, 17940240, 17941874, 17941875, 17956888, 17959601, 17962539   10.\tPC0820RXC, Lot Numbers:  17905297, 17919723, 17942803, 17945491 11.\tPC0830RXC, Lot Numbers:  17910553, 17916481, 17919724, 17928285, 17931762, 17934630, 17936244, 17939531, 17945884, 17945885, 17949962, 17955967, 17959602  12.\tPC0840RXC, Lot Numbers:  17904654, 17907246, 17910556, 17912285, 17913915, 17918979, 17918980, 17920427, 17921809, 17924451, 17926321, 17928286, 17929771, 17931763, 17933387, 17935170, 17936245, 17936922, 17936923, 17941421, 17941422, 17941876, 17941877, 17947267, 17947268, 17948772, 17949964, 17951256, 17958217, 17959603, 17961226 13.\tPC0920RXC, Lot Numbers:  17949965 14.\tPC0930RXC, Lot Numbers:  17906531, 17914902, 17929126, 17934632, 17941424, 17945244, 17946676, 17946963, 17960312  15.\tPC0940RXC, Lot Numbers:  17907250, 17912290, 17914198, 17916482, 17917085, 17919725, 17928287, 17931103, 17935173, 17936247, 17939532, 17940242, 17945886, 17950287, 17955668 16.\tPC1030RXC, Lot Numbers:  17911881, 17913484, 17918070, 17934633, 17940243, 17947080   17.\tPC1040RXC, Lot Numbers:  17913485, 17917086, 17917087, 17917088, 17920429, 17927599, 17929128, 17931104, 17934634, 17935176, 17936248, 17940244, 17940245",
      "firm_fei_number": "1016427",
      "recalling_firm": "Cordis Corporation",
      "address_1": "14201 NW 60th Ave",
      "city": "Miami Lakes",
      "state": "FL",
      "postal_code": "33014-2802",
      "additional_info_contact": "Cordis QA\n786-313-2087",
      "reason_for_recall": "Distal tip may become separated from the lumen wire in specific lots.",
      "root_cause_description": "Process control",
      "action": "The firm initiated the recall by letter on 02/11/2021.  The letter explained the reason for recall and potential impact to the patient, along with the request to further disseminate the notices and return of the recalled units.",
      "product_quantity": "18218 units",
      "distribution_pattern": "US (except MT and NM) and Taiwan",
      "openfda": {
        "pma_number": [
          "P050019",
          "P180010",
          "P070012",
          "P240009",
          "P140026",
          "P050025",
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          "P210030",
          "P030047",
          "P240029",
          "P040012",
          "P040038"
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        "registration_number": [
          "3002807314",
          "2024168",
          "3013556777",
          "1016427",
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        "device_name": "Stent, Carotid",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}