{
  "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": "2026-08-13",
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      "cfres_id": "196745",
      "product_res_number": "Z-0325-2023",
      "event_date_initiated": "2022-10-21",
      "event_date_posted": "2022-11-29",
      "recall_status": "Open, Classified",
      "res_event_number": "91079",
      "product_code": "OGJ",
      "product_description": "Busse JOINT INJECTION TRAY -Intended as a nerve block \nREF No. 8561 R1",
      "code_info": "UDI-DI: (01)00849233016712\nLot Number: 2230276",
      "firm_fei_number": "2433012",
      "recalling_firm": "Busse Hospital Disposables, Inc.",
      "address_1": "75 Arkay Dr",
      "city": "Hauppauge",
      "state": "NY",
      "postal_code": "11788-3707",
      "reason_for_recall": "Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable",
      "root_cause_description": "Device Design",
      "action": "Busse issued Product Recall Notification Letter dated 10/20/22 to Distributor; End User via Email on 10/21/2022 and Certified Mail on 10/24/2022 Letter states reason for recall, health risk and action to take:\n1. Immediately check your inventory for the lots listed above.\n2. Do not use the drape included in the product with the lot number(s) listed above.\n3. Complete the enclosed Response Form within the next 10 days and return via email to\ncsabillon@busseinc.com even if you have no affected product on hand.\na. If you do have product in stock, destroy the drape following your facility policy.",
      "product_quantity": "80 cases",
      "distribution_pattern": "TX",
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        "device_name": "Nerve Block Tray",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5140",
        "device_class": "2"
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    }
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}