{
  "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": "13 lots; 12820 units (multiple units per lot)",
      "code_info": "Product code 900-1139, 13 lots:  111112985  111123474  112010023  112041179  112072768  112083208  112093742  112103742  112114377  113015573  113109708  140211533  140412580",
      "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 1118FR.- CUSTOM ED  CONTENTS:  (1) WRAPPER 24\" X 24\"   (1) LABEL ID PATIENT  (1) TRAY ORGANIZER   (1) PVP TRIPLE SWABSTICK IODOPHOR  (2) GLOVE MED FREETOUCH VYNIL P/F   (1) JELLY LUBRICATING 5 GRAM  (1) TOWEL 3PL Y POLY 17\" X 18\"   (2) SWABSTICK DRY COTTON  (1) DRAPE 4\" FENESTRATED 18\" X 26\"   (1) CATHETER FOLEY 18FR, 2WAY SILICONE COATED  m SYRINGE 10ccWATERPREFIL UF   (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX UF  (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-2374-2014",
      "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"
    }
  ]
}