{
  "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": "54 lots; 2965 units (multiple units per lot)",
      "code_info": "Product code 900-997, 54 lots:  109010132  109020292  109061223  109061459  109081892  109092100  109102355  109112608  109122830  110010122  110030692  110030798  110061476  110071720  110081986  110092293  110092410  110112818  111010176  111020308  111030676  111041119  111051306  111061572  111071842  111082121  111082231  111092411  111102790  111113148  111123310  112020497  112030758  112041366  112052028  112072881  112083445  112093959  112104309  112125125  113015522  113025975  113026120  113036394  113057518  113078481  113088901  113099461  113109885  140111263  140211865  140312193  140412708  140513386",
      "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) TABLE COVER 44\" x 90\"  (2) LEGGINS W/7\" CUFF 30\" x 42\"  (1) ABDOMINAL DRAPE WITH TAPE LIF   (2) TOWELS ABSORBENT 15\" X 20\"  (10) GAUZE SPONGE 4\" X 4\" 16PLY   (2) DRESSING NON ADH TELFA 4\" X 3\"  (1) ROBINSON RED CATHETER 14FR.   (1) UNDERBUTTOCK DRAPE WITH POUCH    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-2365-2014",
      "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"
    }
  ]
}