{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "184601",
      "product_res_number": "Z-0551-2021",
      "event_date_initiated": "2020-11-10",
      "event_date_created": "2020-12-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-07-06",
      "res_event_number": "86807",
      "product_code": "NQB",
      "k_numbers": [
        "K032104"
      ],
      "product_description": "PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.",
      "code_info": "Lot Codes: BTR192864, BTR194678, BTR192872, BTR193024  Serial ID: 20-PKP-00994,20-PKP-00988,20-PKP-00989,20-PKP-00990,20-PKP-00991,20-PKP-00992,20-PKP-00993,20-PKP-00995,20-PKP-00996, and 20-PKP-00997",
      "firm_fei_number": "3009809074",
      "recalling_firm": "TissueTech, Inc.",
      "address_1": "8305 NW 27th St Ste 101 8305 NW 27th St",
      "address_2": "Ste 101",
      "city": "Doral",
      "state": "FL",
      "postal_code": "33122-1934",
      "reason_for_recall": "Potential exposure of product to microbial contamination.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Written notification letter titled, \"URGENT Medical Device Voluntary Recall Notification PROKERA Self-Retaining Biologic Corneal Bandage\" was sent to all consignees on 11/10/2020. Each customer was sent a letter as well as a reconciliation sheet that listed the specific impacted serial IDs from the PROKERA product line (including PROKERA, PROKERA PLUS and PROKERA Slim). The required action's mentioned in the letter include: Notifying the firm via email at customerfeedback@biotissue.com whether the impacted product remains at the consignee's facility using the reconciliation sheet attached to the letter. The letter also mentions for the consignee to discontinue using any remaining units within the impacted lots. Bio-Tissue will provide the consignee with shipping materials to return affected product.",
      "product_quantity": "10 units",
      "distribution_pattern": "US Nationwide distribution including in the states of FL, MN, NY, NC, SC, NJ, GA, PA, MD, DC, OH, WA, MI, CO, KS, TN, ME, AL, AR, TX, KY, MA, CA, CT, and OK.",
      "openfda": {
        "registration_number": [
          "3004802740",
          "3010097171",
          "3042228518"
        ],
        "fei_number": [
          "3009809074",
          "3010097171",
          "3042228518"
        ],
        "device_name": "Conformer, Ophthalmic, Biological Tissue",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.3130",
        "device_class": "2",
        "k_number": [
          "K032104"
        ]
      }
    }
  ]
}