{
  "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": "7 lots, 259 packed units, multiple units for lot.",
      "code_info": "900-2618, 7 lots:  113078598  113099489  113109819  131110407  140211729  140412561  140513137",
      "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": "Open Heart Pack, code 900-2618, contains:  (9) DRAPE 60\" X 76\" REINFORCED LIF  ( 1) MAYO STAND COVER REINFORCED LIF  (6) TOWELS ABSORBENT 15\" X 20\" L/F  ( 1) TABLE COVER BTC 77\" X 110\" HD FULL COVERAGE LIF  ( 1) MAYO TRAY LARGE  (8) DRAPE UTILITY WfTAPE LIF  (1 ) TABLE COVER REINFORCED 44\" X 78\" LIF  (2) GOWN SURG. SMS POLY-REINF BREATHABLE AAMI IV X-LARGE T/WRAP  ( 1) DRAPE SPLIT CARDIO W/CLEAR ANEST. SC STD SMS  ( 1) SHEET SPLIT BILATERAL 84\" X 80\" 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-2482-2014",
      "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"
    }
  ]
}