{
  "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": "5 lots; 180 units (multiple lots per unit)",
      "code_info": "Product code 900-366,  5 lots:  113026100  113057477  113078475  113088811  113109832",
      "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": "ANGIODRAPE PACK -  -  (1) GUIDEWIRE 0.035\" X 150cm  (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK UF  (2) Pr. SURGICAL GLOVES #8  (2) GOWN STANDARD LARGE SMS VELCRO NECK  (2) NEEDLE HYPODERMIC 21G X 1 W' UF  (1) TABLE COVER 44\" X 90\"  (3) CLOTH HUCK TOWELS BLUE  (2) UTILITY BOWL 16oz L/F  (1) SOLUTION SURGICAL DURAPREP 26ML UF  (3) DRAPE UTILITY WITH TAPE UF  (3) TOWEL CLAMP  (2) TOWELS ABSORBENT 15\" X 20\" UF  (1) NEEDLE 18G X 2% AMC/4  (1) FEMORAL ANGlO DRAPE WITH POUCH UF  (1) BAND BAG RUBBAND & TAPE UF  (1) CUP DENTURE WITH LID  (30) GAUZE SPONGE 4\" X 4\" 12PL Y  (2) TIP ASBORBENT APPLICATOR STICK SPONGE  (1) SCALPEL WITH HANDLE #11  (1) STOPCOCK 3 WAY  (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F  (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK 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-2319-2014",
      "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"
    }
  ]
}