{
  "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": "2 lots/ 36 units",
      "code_info": "900-3118; 2 lots:  131210806  140111440",
      "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": "Breast Pack- FJG, code 900-3118, contains:  (2) GOWN LARGE STANDARD SMS AAMIIII  (2) TOWEL ABSORBENT 15\" X 20\"  (1) PENCIL CAUTERY PUSH BOTTOM  (1) SYRINGE BULB 60CC  (1) TUBE SUCTION CONNECT~\" X 12'  (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG  (1) BOWL UTIL TIY QUART 32oz  (1) COVER MAYO STAND REINFORCED  (2) SKIN MARKER WITH RULER  (2) RULER  (1) COVER TABLE REINFORCED 50\" X 90\"  (2) CUP DENTURE 8oz TEAL WITH LID  (6) TOWEL CLOTH HUCK BLUE  (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK  (1) YANKAUER SUCTION TUBE WITHOUT VENT  (1) DRAPE BREAST/CHEST SMS  (10) SPONGE LAP PREWASH 18\" X 18\" XRD  (1) SHEET% DRAPE REINFORCED 60\" X 77\"  (4) DRAPE UTILITY WITH TAPE  (1) BLADE SURG. #15 CARBON STEEL  (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 6.5 POWDER FREE  (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7 POWDER FREE  (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7.5 POWDER FREE  (10) GAUZE SPONGE 4\" X 4\" 16PLY  (1) PK. STRIP STERI CLOSURE W' X 4\"  (1) NEEDLE SPINAL ANESTH 22G X 3Y2  (1) NEEDLE HYPODERMIC 22G X 1Y2  (1) IV PRIMARY ADD ADMINISTRAT SET  (1) STOPCOCK 3WAY WSWIVEL MALE  (1) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK  Product Usage:  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-2527-2014",
      "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"
    }
  ]
}