{
  "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": "6 lots, 180 units (multiple units per lot)",
      "code_info": "Code 900-2917, 6 lots  113047022  113057702  113068036  113078732  113109798  140312146",
      "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": "ACDFPACK  SURGICAL CENTER, CODE 900-2917.  CONTENTS:  \t  (1) SOLUTION SURGICAL DURAPREP 6ML  LIF  (4) Prs. GLOVE SURG. DERMA PRENE # 8 PF LIF  (3) GOWN SOFT SMS STD XL SET IN SLEEVE LIF   (3)    TOWELS  ABSORBEN 15\" X 20\" UF  (1)    TABLE COVER REINFORCED 50\" X 90\" L/F   (1) MAYO STAND COVER REINFORCED LIF  (2) DRAPE o/.. 60\" X 76\" REINFORCED LIF   (1)DRAPE THYROID 100\" X 142\" X 72\"  LIF  (1) FLUORO COVER 30\" X 30\" W/RUBBAND L/F   (1) DRAPE INCISE IOBAN 13\" X 13\"  (2) LITE GLOVE LIF  (2)    TUBE SUCTION CONNECT.  W X 12' LIF   (12)  TOWELS CLOTH HUCK BLUE LIF  (1) UTILITY BOWL  16oz LIF  (10)   GAUZE SPONGE 4\" X 4\" 16PLY XRD LIF  (5) LAP SPONGE PREWASH 18\" X 18\" XRD LIF  (1) SKIN MARKER W/RULER LIF  (9) LABELS FOR SKIN MARKERS 1.25 X Y:!   (1) RULER  (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG  LIF  (2) SYRINGE 20cc W/0 NDL  LUER LOCK LIF   (2) SYRINGE 3cc W/0 NDL  LUER LOCK LIF   (1) BULB SYRINGE 60cc LIF  (3) NEEDLE HYPODERMIC 18G X 1Y:! LIF   (1) NEEDLE 30G X 1 DISP. L/F  (1) NEEDLE SPINAL ANESTH 18G X 3W'  LIF   (2) BLADE SURGICAL# 15 CARBON STEEL   (1)    TIME OUT BEACON NON  WOVEN LIF  (2)    TAPE TEGADERM 2 3/8 \"X 2 o/.. \"L/F  (2) \tMEDICINE CUP 2oz LIF  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-2511-2014",
      "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"
    }
  ]
}