{
  "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": "160968",
      "product_res_number": "Z-0546-2018",
      "event_date_initiated": "2017-06-27",
      "event_date_created": "2018-02-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-07-27",
      "res_event_number": "78950",
      "product_code": "PWY",
      "k_numbers": [
        "K032432",
        "K110883"
      ],
      "product_description": "Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986\n\nProduct Usage:\nSurgical procedure",
      "code_info": "Lot Numbers/Expiration Dates: 1) 1620888/Expiration Date: 12/30/2017 2) 1620367/Expiration Date: 09/01/2017",
      "firm_fei_number": "2433012",
      "recalling_firm": "Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables",
      "address_1": "75 Arkay Dr",
      "city": "Hauppauge",
      "state": "NY",
      "postal_code": "11788-3707",
      "reason_for_recall": "BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On June 27, 2017, Busse Hospital Disposables distributed Urgent Medical Device Recall notices and Response Forms to their customers via courier service.  A copy of the supplier's recall notice was also provided to customers.  \nCustomers were advised to conduct the following:\n\"\tDiscontinue use of needle immediately.\n\"\tPlease check your inventory and cease distribution immediately.\n\"\tIf you have distributed the above products, please contact your customers and inform them of this recall immediately. \n\"\tContact Busse Hospital Disposables for a Return Good Authorization number. \n\"\tComplete and  Return the Response Form via fax to 631-435-2849 or via email to: ijacobo@busseinc.com.  \nCustomers with questions may call 631-435-4711, ext. 254.",
      "product_quantity": "15 cases",
      "distribution_pattern": "US Nationwide Distribution",
      "openfda": {
        "device_name": "Lumbar Puncture Tray (Adult & Pediatric)",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5570",
        "device_class": "2",
        "registration_number": [
          "1018470",
          "3009888344",
          "3004519921",
          "2433012",
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        ],
        "fei_number": [
          "3000203000",
          "1018470",
          "3009888344",
          "2433012",
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      }
    }
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}