{
  "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": "14 lots; 580 units (multiple units per lot)",
      "code_info": "Product code 900-796,  14 lots:  113047032  113057507  113067965  113078346  113088892  113109873  131110279  131210842  140111251  140211700  140311949  140312388  140513145  140513340",
      "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": "FEMORAL ANGIOGRAPHY PACK -   (1) TABLE COVER REINFORCED 50\" X 90\" UF  (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF  (1) TOWEL ABSORBENT 15\" X 20\" UF  (1) DRAPE ANGlO 75\" X 145\"  (4) TOWELS CLOTH HUCK (BLUE) UF  (3) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF  (1) IV ADM SET 15ML 1 06\" LONG LIF  (20) GAUZE SPONGE 4\" X 4\" 12PL Y LIF  (1) NEEDLE HYPODERMIC 18G X 1Y:. ST. UF  (1) NEEDLE HYPODERMIC 21G X 1Y:. ST. LIF  (2) MEDICINE CUP 2oz. CLEAR LIF  (1) SCALPEL WEIGHTED SAFETY #11  (2) CHLORASCRUB SWABSTICK 5.1 ML LIF  (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP LIF  (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL LIF  (1) NEEDLE HYPODERMIC 25G X 5/8 ST. LIF  (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF  (1) FORCEP ADS ON TISS. WITH TIP LIF  (1) UTILITY BOWL 32oz LIF  (1) UTILITY BOWL 16oz L/F  (1) FORCEP KELLY STRAIGHT 5.5\" LIF  (1) MOSQUITO HALSTED CVD 5\" LIF  (1) TRAY ORGANIZER FULL DEEP LIF  (1) SCISSOR MAYO 6.75 STRAIGHT LIF  (1) HOLDER NEEDLE WEBSTER 4.75 LIF  (1) GUIDEWIRE .035\" X 150cm UF  (1) TIME OUT BEACON NON WOVEN ST. UF  (1) MAYO TRAY SMALL LIF  (2) TOWEL CLAMP UF  (2) BAG BAND RUBBAND & TAPE LIF  (1) Pr. GLOVE SURG. #7Y:. DERMA PRENE P/F LIF  (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF  LABEL SAMPLE  (1) NEEDLE & BLADE COUNTER 60C FOAM STRIP/MAG STRIP LIF  (1) NEEDLE 18G X 2 o/.i AMC/4  (1) SKIN MARKER INK WITH/8 LABEL    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-2352-2014",
      "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"
    }
  ]
}