{
  "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": "16 lots; 570 units (multiple units per lot)",
      "code_info": "Product code 900-1488, 16 lots:  111123348  112010051  112020372  112030619  112041075  112072775  112104146  112124636  112124951  113025839  113026046  113036412  113078257  131210748  140211642  140412601",
      "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": "ANGIOGRAPHY PACK -   (1) LINE H.P. 1200 PSI 48\" M/F  (1) ANG. FEMORAL DRAPE WITH POUCH UF  (1) PLATFORM TRAY LARGE  (3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF  (1) TABLE COVER REINFORCED 50\" X 90\" LIF  (2) BAG BAND RUBBAN & TAPE UF  (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF  (5) ABSORBENT TOWELS 15\" X 20\" LIF  (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF  (1) SURGICAL DURAPREP SOLUTION 6ML LIF  (1) SAFETY SCALPEL #11 STAINLESS STEEL  (2) GOWN STANDARD SMS LARGE VELCRO NECK  (1) MANIFOLD WITH CONTROL SYRINGE  (1) NEEDLE 18G X 2% AMC/4  (2) UTILITY BOWL 16oz UF  (2) CLOTH HUCK TOWEL BLUE  (2) NEEDLE HYPODERMIC 21 G X 1 ~ LIF  (2) MEDICINE CUP 2oz LIF  (30) GAUZE SPONGE 4\" X 4\" 16PL Y  (1) NEEDLE HYPODEMIC 18G X 1 ~  (4) TOWEL CLAMP  (2) SYRINGE 3cc WITHOUT NEEEDLE LUER LOCK LIF  (1) HALSTED MOSQUITO CVD 5\" SERRAT  (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F  (2) NEEDLE HYPODERMIC 22G X 1    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-2396-2014",
      "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"
    }
  ]
}