{
  "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": "1 lot; 30 units (multiple units per lot)",
      "code_info": "Product code 900-1238, 1 lots:  109071538",
      "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": "OB PACK -   (2) EXAM GLOVES MED.  (1 0) GAUZE SPONGES 4\" X 4\" 12PL Y  (2) LEGGINS W/ 7\" CUFF  (2) DRAPE SHEET SMS  (1) ABDOMINAL DRAPE W/TAPE  (1) PLASTIC BOWL W/Lid 70 oz.  (1) EAR/ULCER SYRINGE 2oz. L/Free  (1) UMBILICAL CORD CLAMP  (1) BABY BEANNIES  (1) PVP SCRUB 8\" STICK SPONGES  (1) MEASURE DISP. PAPER TAPE 24\"  (1) IMP .REINFORCED GOWN XLge. SMS  STERILE  (1) TABLE COVER Reinf. L/Free  (1) SYRINGE 1cc W/NDL. 25G X 5/8 SLIP TIP L/Free  (2) PAD OBSTETRICAL XLGE ST.  (1) UNDERBUTTOCK DRAPE W/POUCH  (1) SYRINGE 10cc W/0 NDL. L/Free  (1) SYRINGE 20cc W/ONDL. L/Lock L/Free  (1) FEEDING TUBE 8 Fr. 15\" LONG  (1) BABY BLANKET IMP. POLY ABS.  (1) NEEDLE HYPODERMIC 23GA X 1\"  (6) ABSORBENT TOWELS L/Free  (1) WRAPPER 24\" X 24\"    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-2380-2014",
      "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"
    }
  ]
}