{
  "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": "Fajardo",
      "address_1": "Calle Igualdad Final #7",
      "reason_for_recall": "Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",
      "address_2": "",
      "product_quantity": "1 lot/ 12 units",
      "code_info": "Code 900-2715, 1 lot:  113099591",
      "center_classification_date": "20140829",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) in the state of  Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.",
      "state": "PR",
      "product_description": "Endovascular Pack, code 900-2715, contains:  ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH POUCH LIF  (2) TOWELS ABSORBENT 15 X 20 LIF  ( I) CONTAINER SPECIMEN 4oz W/LID & LABEL Llf  (2) BAG BAND FLUOROSCOPE 36 X 30 LIF  ( I) NEEDLE HYPODERMIC 21G X I Y, LIF  (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI III LIF  (2) SOLUTION SURGICAL DURAPREP 6ML LIF  ( I) BAG BAND RUB BAND & TAPE 42 X 38 LIF  (4) TOWELS CLOTH HUCK BLUE LIF  (I) Pr. GLOVE SYNTEGRA CR 6.5 POWDER FREE Llf  (2) Pr. GLOVE SYNTEGRA CR 8 POWDER FREE LIF  ( I) NEEDLE HYPODERMIC 25G X 5/8 LIF  ( I) SYRINGE 30CC WITHOUT NEEDLE LUER LOCK LIF  (I) COYER TABLE 44 X 90 LIF  ( I) SCALPEL WITH HANDLE   (25) GAUZE SPONGES 4 X 4 12PLY LIF  (2) CLAMP TOWEL  (2) SYRINGE I OCC WITHOUT NEEDLE LUER LOCK LIF  ( I) NEEDLE HYPODERMIC 18G X I Y, LIF  ( I) SHARP STOP NEEDLE HOLDER LIF  ( I) TRAY ORGANIZER FULL DEEP  ( I) NEEDLE 18G X 23  (I) BOWL UTILITY BLUE 16oz LIF  ( I) WRAPPER 24X 24 LIF  Product Usage:  EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.",
      "report_date": "20140910",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Customed, Inc",
      "recall_number": "Z-2498-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "68536",
      "termination_date": "20170814",
      "more_code_info": "",
      "recall_initiation_date": "20140520",
      "postal_code": "00738",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}