{
  "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": "51 lots; 11070 units (multiple units per lot)",
      "code_info": "Product code 900-1296, 51 lots:  110102576  110112604  110112865  110122889  110123065  111010033  111020358  111030562  111030827  111030934  111041085  111051267  111051325  111061488  111061600  111061645  111072036  111082183  111082197  111092481  111102671  111112927  111123333  112010033  112010243  112020326  112030613  112041246  112041437  112062581  112114631  112124934  112125280  113015634  113025909  113036727  113047212  113047323  113068143  113078567  113078691  113089183  113109718  131110066  131110595  131210958  140111405  140211870  140412595  140412882  140513344",
      "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": "PREMIUM LAPAROTOMY PACK - CUSTOMED-  (1) DRAPE T LAPAROT 102\" X 78\" X 121\"  (1) GOWN XL SMS IMPERVIOUS REINFORCED  (1) COVER TABLE REINFORCED 50\" X 90\" LIF  (1) COVER MAYO STAND REINFORCED LIF  (4) DRAPE UTILITY WITH TAPE LIF  (4) TOWELS ABSORBENT 15\" X 20\" LIF  (5) SPONGE LAP PRE-WASH 18\" X 18\" XRD LIF  (1) YANKAUER SUCTION TUBE W/0 VENT LIF  (1) TUBE SUCTION CONNECT~~~ X 12' LIF  (1) BLADE SURGICAL #10 CARBON STEEL  (1) BLADE SURGICAL #15 CARBON STEEL  (1 0) GAUZE SPONGES 4\" X 4\" 16PL Y XRD LIF  (2) DRAPE SHEET 42\" X 55\" LIF    EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.  (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP",
      "report_date": "20140910",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Customed, Inc",
      "recall_number": "Z-2384-2014",
      "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"
    }
  ]
}