{
  "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": "43 lots; 3201units (multiple units per lot)",
      "code_info": "Product code 900-1061, 43 lots:  110051144  110061480  110071614  110082107  110102421  110112595  110123081  111010014  111020502  111030541  111030814  111040868  111061579  111071751  111082041  111082267  111092342  111102654  111112942  112020305  112051670  112062315  112072764  112083153  112093849  113025926  113026038  113036447  113046995  113047194  113057377  113057824  113068139  113078455  113099265  113099585  131110150  131210675  131211024  140311916  140312431  140412826  140513473",
      "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": "PERl GYN PACK-    (1) DRAPE UTILITY WITH TAPE UF  (2) TOWELS ABSORBENT 15\" X 20\" UF  (1) TOP DRAPE WITH ADHESIVE STD SMS  (1) CATHETER NELATON ROB. 14FR.  (2) GOWN IMPERVIOUS EXTRA REINFORCED XL  (1) UNDERBUITOCK DRAPE WITH POUCH  (2) LEGGINS WITH 7\" CUFF 30\" X 42\"  (1) TABLE COVER REINFORCED 44\" X 78\" UF  (1 0) GAUZE SPONGES 4\" X 4\" 16PL Y XRD LIF    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-2370-2014",
      "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"
    }
  ]
}