{
  "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": "18 lots; 730 units (multiple units per lot)",
      "code_info": "Product code 900-1294, 18 lots:  111030560  111030815  112020527  112114630  112124933  113015688  113026042  113036408  113057858  113089182  113109717  131110166  131210694  140211638  140312063  140412594  140513078  140513477",
      "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 CESAREAN PACK- CUSTOMED-    (1)BABY BLANKET IMP. 30\" X 30\" POLY ABSORBENT  (3) TOWELS ABSORBENT 15\" X 20\" LIF  (1) BOWL PLASTIC 80oz WITH LID  (10) LAP SPONGE PREWASH XRD LIF  (2) PAD OBSTETRICAL X-LARGE ST.  (1) MAYO STAND COVER REINFORCED LIF  (1) DRAPE SHEET 41 \" X 58\" SMS LIF  (1) TUBE SUCTION CONNECT. X\" X 12' LIF  (1) EAR ULCER SYRINGE 2oz LIF  (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF  (1) CORD UMBILICAL CLAMP LIF  (1) DRESSING ISLAND 4\" X 10\"  (1) BLADE SURGICAL#10 CARBON STEEL  (1) BLADE SURGICAL#20 CARBON STEEL  (1) TABLE COVER REINFORCED 50\" X 90\" LIF  (1) C-SECTION DRAPE WITH POUCH  (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI III  (1) GOWN SURG. REINFORCED LARGE AAMI III TOWEL WRAP    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-2382-2014",
      "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"
    }
  ]
}