{
  "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": "7 lots/236 units, multiple units per lot",
      "code_info": "Product code 900-2039, 7 lots:  112062199  113026170  113057698  113099418  131110232  140311817  140312114",
      "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": "ORTHOPEDIC SURGICAL PACK    HOSPITAL SAN CRISTOBAL  CONTENTS:\t  (I)  CAUTERY TIP POLISH ER LIF (1)   BAG SUTURE FLORAL  (1)   TUBE SUCTION CONNECT W' X 1 2' LIF  (1)   BAG GLASSINE (2)   LITE GLOVE  (1)   TABLE COVER BTC 77\" X 11 0\" HD FULL COVERAGE  LIF  (1)   MAYO STAND COVER REINFORCED  LIF (5)   TOWELS ABSORBENT  1 5\" X 20\" LIF  (4)   DRAPE UTILITY WITH TAPE  LIF ( 1 )  DRAPE SHEET 70\" X 100\" L/ F  (5)   LAP SPONGE  PREWASH 18\" X 1 8\" XRD LIF (1 )  MAYOTRAYLARGE  (1)   DRAPE TOP WITH ADHESIVE  108\" X 50\" STD SMS LIF  (1)   SKIN STAPLER  WIDE  35 LIF  ( 1)   DRAPE INCISE ANTI M I CROBIAL 23\" X 1 7\" LIF (1)   SKIN  MARKER WITH RULER  (1)   U-DRAPE 60\" X 70\" WITH TAPE SPLIT 6\" X 2 1 \" LIF (1 )   PAD ABDOM INAL 8\" X 7\"h.''  (1)   YAUNKAUER  SUCTION TUBE WITHOUT VENT LIF  (1)   SOLUTI ON SURG ICAL DURAPREP 26ML LIF (1 )  BLADE SURG ICAL #10 STAINLESS STEEL  (I) SPLIT SHEET WITH ADHESIVE 108\" X 77\" STD SMS LIF (2)  *Prs. GLOVE  # 8.5 SURGEON  NEUTRALON  LATEX  ( I ) *Pr. GLOVE# 8 SURGEON  NEUTRALON  LATEX  ( I )   GOWN SURG. REINFORCED XL TOWEL/WRAP AAMI  Ill (3)   GOWN XL SMS IM PERVIOUS REINFORCED AAM I   III LIF ( I )   CAUTERY  PENCIL ROCK ER SWITCH  (2)  *Prs. GLOVES SURG. # 8 POWDER  (4)   Prs. GLOVES SURG. 8.5      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-2432-2014",
      "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"
    }
  ]
}