{
  "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": "1 lot/15 units",
      "code_info": "Product code 900-2122, 1 lot:  112124868",
      "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": "NEURO SPINE PACK    CONTENTS: (1)   SUTURE BAG FLORAL LIF  (1)   NEEDLE & BLADE COUNTER SOC FOAM STR//MAG STR (2)   COVER TABLE BTC 77\" x 110\" HD FULL COVERAGE LIF (4)    DRAPE UTILITY WITH TAPE LIF  (1)   SHEET 'I\" 60\" X 77\" DRAPE REINF. LIF  (2)   SPECIMEN CONTAINER 4oz W/LID & LABEL  (2)   CUP MEDICINE 2oz UF  (2)   TUBE SUCTION CONNECT v.'' X 12' UF (2)   SKIN MARKER INK WITH 8 LABEL  (20) GAUZE SPONGE 4\" X 4\" 16ply XRD UF  (5)   SPONGE LAP PREWASH 18\"X 18\" XRD UF (2)   SYRINGE 20cc W/0 NDL LILOCK ST.LIF  (1)   YANKAUER SUCT. TUBE W/0 VENT LIF  (1) \tDRAPE INCISE ANTIMICROBIAL 23\" X 17\"  LIF (1)\tPOLISHER CAUTERY TIP  LIF  (2)    PENCIL CAUTERY HAND SWITCHING LIF  (1)\tDRAPE T LAPAROTOMY 102\" X 78\" X 121\" STD SMS  LIF (1)   GOWN SURG REINFORCED LARGE TOWEL WRAP  (2)    BLADE SURG #15  CARBON STEEL     (1) \tPK.STRIP SURGICAL %\" X 6\"  COTTON (1) \tPK.STRIP SURGICAL Y4\" X 6\" COTTON (10)   GAUZE SPONGE 4\" X 4\" 16ply  (1) \tNEEDLE HYPODERMIC 20G X 1 % (1) \tBASIN WASH ROUND 6qt  (4) \tSHEET DRAPE 42\" X 57\"  SMS LIF  (2) \tDERMABOND HV TOPICAL SKIN ADH (1) \tBOWL UTILITY 32oz.  (2) \tSYRINGE EAR/ULCER 2oz LIF  (2) \tBLADE EXTENDED ELECTRODE  (2) \tSOLUTION SURGICAL DURAPREP 26mL UF (1) \tELECTRODE NEEDLE 1in W/TIP PROTECTOR  (1) \tSTRIP SURGICAL 'I\"X 6\"  (2) \tGOWN XL SMS IMPERV. REINFORCED UF  (1) \tCORD BIPOLAR FIRCEPS  (4) \tTOWEL CLOTH HUCK (WHITE)  (2) \tDRESSING OPSITE POST PO 2%\" x 2\" (2) \tPOUCH INSTRUMENT 7 X 11  (1) \tMAYO TRAY LARGE  (1) \tMAYO STAND COVER REINFORCED 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-2434-2014",
      "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"
    }
  ]
}