{
  "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": "7 lots; 176 units (multiple units per lot)",
      "code_info": "Product code 900-1408, 7 lots:  113015546  113057835  140211780  140412600  140513084  113047152  112051753",
      "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": "UMBILICAL VESSEL CATHETER KIT - CUSTOMED-    (1) PAPER TAPE MEASURE DISP. 24\"  (1) FENESTRATED DRAPE 18\" x 26\" LIF  (1) NEEDLE HOLDER BAUMGARTNER 5\"  (2) HALSTED MOSQUITO CVD 5\" SERRAT  (1) ADSON FORCEP TISS. Wff  (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF  (6) GAUZE SPONGE 2\" X 2\" 8PL Y  (6) GAUZE 4\" X 4\" 16PL Y  (1) SYRINGE 1 cc TB SffiP  (1) IRIS FORCEP SERR Y. CVD 4\" WITH PROTECTOR TIP  (1) NEEDLE WITH FILTER 18 X 1 Y. BLUNTffiP  (1) SUTURE 3-0 BLK MONOFIL  (1) TRAY ORGANIZER FULL DEEP  (1) WRAPPER 30\" X 30\" L/F  (1) PVP TRIPLE IODOPHOR SWABSTICK  (1) TONGUE DEPRESSOR 6\" WOOD  (1) IRIS SCISSOR STRAIGHT 4 Y. W/PROTECTOR TIP  (1) SCALPEL WITH HANDLE #11  (1) MOSQUITO FORCEP STRAIGHT 5\"  (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF  (2) 3 PLY POLY TOWEL  (1) UMBILICAL TAPE  (1 ) PROBE GRONED & DISNEETNS 6\" 2ML  (1) EYE DRESSING EXT FINE POINT FULL  (2) NEEDLE WITH FILTER 18 X 1 Y. NOKOR PO  (1) PLASTIC TRAY 2/COMPARTMENT  (1) HALF TRAY  (1) STOPCOCK 3 WAY LUER SLIP    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-2392-2014",
      "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"
    }
  ]
}