{
  "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": "26 lots; 1305 units (multiple units per lot)",
      "code_info": "Product code 900-610,  26 lots:  111123130  111123272  112010190  112030731  112041339  112051998  112062498  112093947  112114578  112125303  113025825  113026192  113036373  113036696  113047161  113057494  113067874  113078337  113089077  113109860  131110268  131210661  140111087  140211673  140311942  140513221",
      "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": "ANGIOGRAPHY PACK -    ( 1) FEMORAL ANGlO. DRAPE WITH POUCH  (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK LIF  (2) NEEDLE HYPODERMIC 21G X 1%  ( 1) TABLE COVER REINFORCED 44\" X 78\" LIF  (30) GAUZE SPONGES 4\" X 4\" 12PLY  ( 1) GOWN IMPERVIOUS REINFORCED LARGE SMS  ( 1) GOWN LARGE NON REINFORCED SMS TOWEL & WRAP  ( 1) GUIDEWIRE .035\" X 150cm MOVABLE  (2) BAND BAG RUBBAND & TAPE L/F  (2) DENTURE CUP 8oz. WITH LID  ( 1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF  ( 1) NEEDLE HYPODERMIC 18G X 1 %  ( 1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F  (4) DRAPE UTILITY WITH TAPE L/F  (2) SOLUTION SURGICAL DURAREP 6ml L/F  (2) TOWEL CLAMP  (1) NEEDLE 18G X 2% AMC/4  (4) TOWELS CLOTH HUCK BLUE  ( 1) UTILITY BOWL 16oz. LIF  ( 1) SCALPEL WITH HANDLE # 11    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-2336-2014",
      "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"
    }
  ]
}