{
  "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": "3 lots/604 units (multiple units per lot)",
      "code_info": "Product code 900-2476 ,3 lot  112020348  112051961  112072725",
      "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": "C - BIRTH PACK II {2)  CUSTOMED  CONTENT:\t  (1)  GOWN SURGEON REINFORCED XLGE TOWEL/WRAP LIF (4)  TOWEL ABSORBENT 15\" X 20\" LIF  (2)  GOWN XLGE SMS IMPERVIOUS REINFORCED LIF (1)  COVER MAYO STAND REINFORCED LIF  (1)  BLANKET BABY 30\" X 30\" POLYABS IMPERVIOUS LIF (1)  SYRINGE EAR/ULCER 2oz LIF  (2) PAD OBSTETRICAL X-LARGE  (1) BOWL WITH/LID PLASTICS 80oz LIF (1)  CLAMP UMBILICAL CORD LIF  (1)  BAG SUTURE FLORAL LIF  (1)  DRAPE C-SECTION W/POUCH 102\" X 121\" X 78\" LIF (1)  COVER TABLE REINFORCED 50\" X 90\" 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-2463-2014",
      "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"
    }
  ]
}