{
  "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": "44 lots; 4670 units (multiple units per lot)",
      "code_info": "Product code 900-1297, 44 lots:  109030542  110061517  110071663  110081957  110082065  110082132  110112605  110112866  110123051  110123066  111030563  111071760  111082184  111082268  111092487  111102647  111102672  111112928  111112962  111123334  112010034  112020327  112041184  112062405  112062406  112062582  112062620  112083387  112114633  112124935  113015426  113025935  113036315  113036450  113047324  113068144  113078692  113109719  131110167  131110596  131210959  140111406  140412596  140513080",
      "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": "PREMIUM O.B. PACK - CUSTOMED-  (1) TABLE COVER REINFORCED 50\" X 90\" LIF  (10) GAUZE SPONGES 4\" X 4\" 12PLY LIF  (2) LEGGINS WITH 7\" CUFF 30\" x 42\" LIF  (2) PAD OBSTETRICAL X-LARGE ST.  (2) SHEET DRAPE 42\" X 55\" LIF  (1) UNDERBUTTOCK DRAPE WITH POUCH LIF  (1) DRAPE ABDOMINAL 40\" X 54\" WITH TAPE LIF  (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF  (1) BOWL PLASTIC 80oz WITH LID  (1) EAR ULCER SYRINGE 2oz LIF  (1) CORD UMBILICAL CLAMP LIF  (1) BABY BLANKET IMP. 30\" X 30\" POLY ABS. LIF  (1) TOWELS ABSORBENT 15\" X 20\" LIF  (1) LAP SPONGE PRE-WASH 18\" X 18\" 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-2385-2014",
      "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"
    }
  ]
}