{
  "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": "12 lots; 190 units (multiple units per lot)",
      "code_info": "Product code 900-1937, 12  lots:  111082312  111113057  112020431  112051902  112062289  113025829  113026168  113067902  113088773  131210660  140211699  140312423",
      "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": "ENDOVENOUS CUSTOM PACK - CUSTOMED    (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F  (1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF  (2) Pr. GLOVE SYNTEGRA CR # 6.5 P/F LIF  (20) GAUZE SPONGE 4\" X 4\" 12PL Y LIF  (3) GOWN SMS X-LARGE STD NON REINFORCED  ( 1) TABLE COVER 44\" X 90\"  (4) DRAPE UTILITY WITH TAPE L/F  ( 1) DENTURE CUP WITH LID  ( 1) UTILITY BOWL 16oz.  (2) COUNTER NEEDLE & BLADE 10c MAG/CLEAR L/F  (4) RUBBER BAND  ( 1) NEEDLE HYPODERMIC 27G X 1 Y..\"  ( 1) SHEET SPLIT WITH ADHESIVE 108\" X 77\" STD SMS LIF  (3) CAP NURSE 21 \" GREEN BOUFFANT  (3) MASK SURGICAL BLUE 120MM HG LIF  ( 1) PREPPING PAD WITH CUFF  (2) TIP ABSORB. APPLIC. STICK SPONGE L/F  ( 1) SCALPEL WEIGHTED SAFETY # 11  ( 1) PROBE DRAPE ST 6\" X 96\" NO GEL LIF  ( 1) WRAPPER 30\" X 30\"  (3) TOWELS ABSORBENT 15\" X 20\" L/F    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-2422-2014",
      "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"
    }
  ]
}