{
  "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 differ 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": "21 lots/ 1196 units, multiple units per lot",
      "code_info": "Product code 900-2038, 21 lots:  112114658  112125063  113026054  113036790  113047157  113057456  113067865  113068044  113078304  113078602  113099284  113109785  131110231  131110604  131211016  131211023  140111450  140311934  140412464  140412897  140513123",
      "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  CONTENTS:\t  (4) CLOTH HUCK TOWEL BLUE  (1) TABLE COVER REINFORCED 50\" x 90\" LIF  (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (2) CUP MEDICINE 2oz LIF  (2) UTILITY BOWL 32oz LIF  (1) EMESIS BASIN 101N 700cc  (4) TOWEL CLAMP  (3) TOWELS ABSORBENT 15\" x 20\" LIF  (1)  MOSQUITO HALSTED  (2) CHLORASCRUB SWABSTICK 5.1ML (1) PLATFORM TRAY LARGE  (1)  SCALPEL SAFETY #11  (3) LABELS FOR SKIN MARKER  (1) LABEL F/MED. SALINE NORMAL BLUE (1)  NEEDLE HYPODERMIC 18G X 1 Y2  (2)  SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 16oz  (4) BAND BAG WITH RUBBAND & TAPE LIF  (20) GAUZE SPONGE 4\" X 4\" 16PLY XRD LIF  (1) FEMORAL ANGIOGRAPHY DRAPE WITH POUCH  (1)  NEEDLE HYPODERMIC 21G X 1 Y2 (1) GOWN STANDARD SMS LARGE  (2) NEEDLE HYPODERMIC 23GA X 1\"  (1) GOWN SMS LARGE NON REINFORCED TOWEL/WRAP (1) LABEL FOR MEDICATION TRIDIL VIOLETA  (1)  LABEL XYLOCAINE FOR MEDICATION YELLOW (1)  LABEL CONTRASTE FOR MEDICATION GREEN (1) WASH BASIN ROUND 6QT.    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-2431-2014",
      "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"
    }
  ]
}