{
  "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": "21 lots; 684 units (multiple units per lot)",
      "code_info": "Product code 900-1922,  21  lots:  110112626  112010102  112030659  112041213  112051899  112062468  112081922  113025826  113036785  113057439  113078286  113088772  113089202  113109767  131110213  140111080  140111186  140211803  140312097  140312460  140412890",
      "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": "AV FISTULA PACK-   (1) DRAPE T LAPAROT 102\" X 78\" X121 \" STD SMS  (3) GOWN SURG. REINFORCED X-LARGE EXTRA LONG LEVEL IV  (1) DRAPE SHEET 42\" X 57\" SMS  (4) DRAPE UTILITY WITH TAPE LIF  (1 0) GAUZE SPONGE 4\" X 4\" 16PL Y XRD LIF  (1) PENCIL CAUTERY HAND SWITCHING LIF  (1) TUBE SUCTION CONNECT \"Y-1\" X 12' LIF  (1) FRAZIER WITH CONTROL VENT & OBTUR 10F LIF  (2) LITE GLOVE LIF  (1) BOWL UTILITY 32oz LIF  (2) BOWL UTILITY 16oz LIF  (10) LAP SPONGE PREWASH XRD LIF  (1) SOLUTION SURGICAL DURAPREP 26ML LIF  (3) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF  (1) SYRINGE 30CC WITHOUT NEEDLE LUER LOCK UF  (1) SYRINGE 5CC WITH NEEDLE 21G X 1% LUER LOCK UF  (2) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF  (1) NEEDLE HYPODERMIC 18G X 1 %  (2) COUNTER NEEDLE & BLADE 10C MAG/CLEAR UF  (1) COVER MAYO STAND REINFORCED LIF  (1) COVER TABLE 44\" X 90\"  (1) MAYO TRAY SMALL  (2) ABSORBENT TOWEL 15\" X 20\" UF  (1) BOWL WITH LID PLASTIC 80oz    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-2419-2014",
      "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"
    }
  ]
}