{
  "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": "32 lots; 984 units (multiple units per lot)",
      "code_info": "Product code 900-1383, 32 lots:  109010046  109020262  109030545  109061169  109061419  109071711  109071724  109091995  109102264  109122744  110010037  110020306  110081959  110092383  110123086  111010040  111030570  111051156  111061493  111061849  111071888  111082185  112051750  112093869  112104143  112114938  113067949  113068039  113099302  113109721  140412844  140613591",
      "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": "PEDIATRIC LAP PACK -   ( I) SHEET MINOR LAP 102\" X 121\" X 78\"  ( I) MAYO STAND COVER REINFORCED LIF  ( I) TABLE COVER REINFORCED 50\" X 90\" LIF  (2) DRAPE SHEET 41 \" X 58\" SMS  (2) TOWELS ABSORBENT 15\" x 20\" LIF  (I ) BAG SUTURE FLORAL LIF  (4) DRAPE UTILITY WITH TAPE L/F    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-2388-2014",
      "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"
    }
  ]
}