{
  "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": "30 lots; 6500 units (multiple units per lot)",
      "code_info": "Product code 900-210, 30 lots:  112030717  112041290  112041446  112051934  112072622  112093725  112114388  112114598  113015442  113015630  113036436  113036760  113047216  113057458  113057699  113057816  113068045  113068165  113078572  113089023  113099285  113109786  131110235  131110605  131210967  140111414  140211876  140312332  140412833  140513348",
      "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-  -  (4) CLOTH HUCK TOWEL BLUE UF  (1) TABLE COVER REINFORCED 50\" X 90\" LIF  (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK UF  (2) MEDICINE CUP 2oz. LIF  (3) UTILITY BOWL 32oz UF  (1) EMESIS BASIN 10 IN 700cc  (4) TOWEL CLAMP  (3) ABSORBENT TOWELS 15\" X 20\" LIF  (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK L/F  (1) HALSTED MOSQUITO  (1) PVP SCRUB 8\" STICK SPONGE  (1) TRAY PLATFORM LARGE  (3) LABELS FOR SKIN MARKERR  (1) LABEL FOR MEDICATION SALINE NORMAL BLUE  (1) LABEL FOR MEDICATION TRIDIL VIOLETA  (1) NEEDLE HYPODERMIC 18G X 1 'h  (4) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF  (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF  (2) UTILITY BOWL 16oz  (3) BAND BAG WITH RUBBAND & TAPE LIF  (25) GAUZE SPONGE 4\" X 4\" 16PL Y XRD LIF  (1) DRAPE ANGlO 75\" X 145\"  (1) NEEDLE HYPODERMIC 21 G X 1 'h LIF  (1) SAFETY SCALPEL #11 LIF  (1) GOWN STANDARD SMS LARGE VELCRO NECK  (2) NEEDLE HYPODERMIC 23G X 1\"  (1) TRAY ORGANIZER FULL DEEP  (1) GOWN LARGE NON REINFORCED SMS TOWEL & WRAP  (1) LABEL XYLOCAINE FOR MEDICATION YELLOW  (1) LABEL CONTRASTE FOR MEDICATION GREEN  (1) LABEL FOR MEDICATION INTEGRILIN RED  (1) PVP PAINT 8\" STICK SPONGE    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-2313-2014",
      "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"
    }
  ]
}