{
  "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": "27 lots; 67410 units (multiple units per lot)",
      "code_info": "Product code 900-1127, 27 lots:  111082044  111092578  111102824  111112983  111123318  112020311  112030602  112041178  112072767  112083205  112093744  113015572  113025906  113036449  113047145  113068141  113088830  113099339  131110626  131210624  140111138  140211532  140211883  140412442  140412828  140513066  140513253",
      "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": "FOLEY CATHETER KIT 1116FR. - CUSTOM ED-    (1) WRAPPER 24\" X 24\"   (1) PVP TRIPLE SWABSTICK IODOPHOR  (2) GLOVE MED FREETOUCH VYNIL P/F   (1) JELLY LUBRICATING 5 GRAM  (1) TOWEL 3PLY POLY 17\" X 18\"   (2) SWABSTICK DRY COTTON  (1) DRAPE 4\" FENESTRATED 18\" X 26\"   (1) CATHETER 16FR. FOLEY, 2 WAY,5cc, Silicone Coated  (1) SYRINGE 10cc WATERPREFIL UF   (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX UF  (1) LABEL ID PATIENT   (1) TRAY ORGANIZER  (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL    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-2373-2014",
      "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"
    }
  ]
}