{
  "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": "23 lots; 1396 units (multiple units per lot)",
      "code_info": "Product code 900-2002, 23 lots:  111113064  111123196  111123470  112010109  112041220  112051915  112062471  112083419  112093922  112104298  112114657  112125310  113015054  113015437  113067910  113088778  113089204  113099408  131110220  140111321  140211502  140211932  140312439",
      "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": "O.B. PACK -   ( I) PVP SCRUB 8\" STICK SPONGES  ( I) UNDERBUTTOCK DRAPE WITH POUCH  (2) LEGGINS WITH 7\" CUFF 30\" x 42\"  ( I) DRAPE ABDOMINAL WITH TAPE LIF  ( I) VAGINAL PACKING SPONGEXRD  ( I) BOWL WITH LID PLASTIC 80oz  ( I) RECEIVING BLANKET 100% COTTON  (I) BABY BLANKET POLY ABSORBENT IMPERVIOUS  (I) CORD UMBILICAL CLAMP  (4) TOWELS ABSORBENT 15\" x 20\" LIF  ( I) UTILITY BOWL 16oz.  (2) TRAY ORGANIZER FULL DEEP  (3) T IP ABSORBENT APPLICATOR  (2) GLOVES EXAM MEDIUM  (2) GOWN LARGE SMS IMPERVIOUS REINFORCED  (10) GAUZE SPONGE 4\" X 4\" 12PLY  (2) PAD OBSTETRJCAL X-LARGE ST.  (I) EAR ULCER SYRINGE 2oz. LIF  (I) BABY BEANNIES  (2) SHEET DRAPE 4 1\" x 58\" SMS LIF  (I) SCISSORS UMBILICAL  (I) TABLE COVER REINFORCED 50\" x 90\" LIF  (2) WRAPPER 24\" X 24\" 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-2427-2014",
      "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"
    }
  ]
}