{
  "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": "23 lots; 804 units (multiple units per lot)",
      "code_info": "Product code 900-1719, 23  lots:  111082259  111092364  111123379  112010086  112020404  112041199  112051873  112062447  112125292  113015635  113026050  113036756  113057398  113067894  113078273  113088759  113099390  113109748  131210760  140111171  140211792  140312084  140412458",
      "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": "CESAREAN PACK -   (1) MAYO STAND COVER REINFORCED LIF  (5) TOWELS ABSORBENT LIF  (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED L/F  (3) DRAPE SHEET 41\" X 58\" SMS LIF  (1) BABY BLANKET PRINTED LIF  (1) BOWL PLASTIC 80oz WITH LID  (1) TUBE SUCTION CONNECT.%\" X 12' LIF  (15) LAP SPONGES PREWASH XRD LIF  (1) EAR ULCER SYRINGE 2oz. LIF  (1) PAD OBSTETRICAL X-LARGE ST. L/F  (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F  (1) SYRINGE 20cc SITIP LIF  (1) FEEDING TUBE 8FR. 15\" LONG  (1) BABY BEANNIES LIF  (1) DRESSING ISLAND 4\" X 14\"  (1) DRAPE C-SECTION WITH POUCH 102\" X 121\" X 78\"  (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP  (1) TABLE COVER REINFORCED 50\" X 90\" L/F  (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF  (1) SUTURE BAG FLORAL LIF  (1) UMBILICAL CORD CLAMP  (1) BLADE SURGICAL #20 CARBON STEEL  (1) WRAPPER 24\" X 24\" L/F    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-2408-2014",
      "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"
    }
  ]
}