{
  "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": "5 lots/280 units, (multiple units per lot)",
      "code_info": "Product code 900-2284 ,5 lots  112083036  112125074  113026297  113057619  113078727",
      "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": "LUMBAR PACK  ADVANCED AMBULATORY SURGICAL CENTER  CONTENTS:       (1) COVER TABLE REINFORCED 50\" X 90\" UF \t(4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF (8) TOWELS CLOTH HUCK BLUE UF \t (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK UF (10) GAUZE SPONGE 4\" X 4\" 16PLY XRD UF \t (1) STRIP STERI DRAPE LARGE 17\" X 23\" UF  (1) SCALPEL WITH HANDLE #11\t(1) COVER FLUORO 30\" X 30\" WITH RUBBER BAND UF (1) DRAPE CHEST 100\" X 142\" X 72\"\t(1) RULER FLEXIBLE PLASTIC  (1) SOLUTION SURGICAL DURAPREP 26ML UF    (1) SHEET :X 60\" X 77\" DRAPE REINFORCED UF  (1) STRIP STERI CLOSURE%'' X 4\" UF \t (2) GOWN SOFT SMS STD. XL SET IN SLEEVE UF (4) NEEDLE HYPODERMIC 18G X 1 % U \t(1) SKIN MARKER W/RULER UF  (1) NEEDLE HYPODERMIC 25 X 1 % UF \t(1) DRESSING TELFA 8\" X 3\" NON ADH UF  (1) DRESSING TEGADERM 4 X 4%\"  UF \t(1) STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VIALL /F (1) BAG ZIP LOCK UF \t (9) LABELS FOR SKIN MARKERS UF    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-2448-2014",
      "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"
    }
  ]
}