{
  "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/ 45 units",
      "code_info": "900-3431, 1 lot:  140513333",
      "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 TPSC, code 900-3431, contains:  (1) GOWN LARGE STANDARD SMS AAMIIII  (1) GOWN SOFT SMS STD. X-LARGE AAMIIII  (4) TOWELS ABSORBENT 15\" X 20\" LIF  (1) PENCIL CAUTERY PUSH BOTTOM LIF  (1) SYRINGE 60ML LUER LOCK WITHOUT NEEDLE L/F  (1) TUBE SUCTION CONNECT X\" X 12' LIF  (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F  (1) COVER MAYO STAND REINFORCED LIF  (2) SKIN MARKER INK WITH 8 LABEL/TIME OUT RULER LIF  (2) BOWL UTILITY QUART 32oz.  (1) COVER TABLE REINFORCED 50\" X 90\" LIF  (1) RULER LIF  (4) DRAPE UTILITY LIF  (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF  (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF  (1) DRAPE BREAST/CHEST SMS LIF  (1) GAUZE KERLIX 4.5\"X 4 1/8 YD 6PL Y L/F  (2) LITE GLOVES  (5) SPONGE LAP PREWASH 18\" X 18\" XRD LIF  (1) SHEET DRAPE 42\" X 57\" SMS LIF  (1) SHEET DRAPE 70\" x 100\" LIF  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-2530-2014",
      "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"
    }
  ]
}