{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "130642",
      "product_res_number": "Z-0238-2015",
      "event_date_initiated": "2014-10-08",
      "event_date_posted": "2014-12-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-08-14",
      "res_event_number": "69448",
      "product_code": "EYN",
      "product_description": "Irrigation Tray With Bulb Syringe, Catalog number 900-020.\n\nUsed by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.",
      "code_info": "Lot numbers: 111112971 111123273 112010006 112020294 112030797 112041052 112041386 112041450 112051644 112062300 112083043 112093635 113025799 113025979 113026274 113036446 113046993 113047330 113057829 113068135 113078452 113078659 113099261 131110143 140111104 140211714 140312032 140412568 140513034 140613550 140814606 140815025",
      "firm_fei_number": "2648727",
      "recalling_firm": "Customed, Inc",
      "address_1": "Calle Igualdad Final #7 #7 calle igualdad final",
      "city": "Fajardo",
      "postal_code": "00738",
      "country": "PR",
      "additional_info_contact": "787-622-5151",
      "reason_for_recall": "Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging.  Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",
      "root_cause_description": "Packaging",
      "action": "Customed initiated a recall on October 8th, 2014 of sterile convenience surgical Packs-trays, bags (known as Convenience Packs) and new lots of products added to the initial June 3, 2014 recall of 233 sterile surgical packs.  The products are being recalled because of significant compromised sterility, not limited to potentially damaged packaging.  Customers were instructed to quarantine and cease use of the affected product identified.  Customers are to return the response form included with the letter, to the contact information provided.  Upon receipt, the firm will contact customers with further instructions to obtain credit, replacement product, and for return of the recalled product or any other disposition action.  If customers have any questions, they should contact the Customed Recall Coordinator at 407-850-5558 extensions 8001 or 8005, or via e-mail: pablo.diaz@customedhealing.com.",
      "product_quantity": "76800",
      "distribution_pattern": "US Distribution to Florida, New York and Puerto Rico..",
      "openfda": {
        "k_number": [
          "K923940",
          "K923941",
          "K790607",
          "K760047",
          "K791020",
          "K944882",
          "K792082",
          "K900148",
          "K801783",
          "K923938",
          "K781748",
          "K923939",
          "K900737",
          "K900736",
          "K781918"
        ],
        "registration_number": [
          "3045816902",
          "3004122598",
          "1319639",
          "1057358",
          "3005012805",
          "1928237"
        ],
        "fei_number": [
          "3045816902",
          "1000208608",
          "3004122598",
          "3005012805",
          "1928237",
          "1000138054"
        ],
        "device_name": "Tray, Irrigation, Sterile",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5980",
        "device_class": "2"
      }
    }
  ]
}