{
  "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",
    "results": {
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  "results": [
    {
      "cfres_id": "216092",
      "product_res_number": "Z-0116-2026",
      "event_date_initiated": "2025-09-18",
      "event_date_posted": "2025-10-09",
      "recall_status": "Open, Classified",
      "res_event_number": "97550",
      "product_code": "OGE",
      "product_description": "PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFC. Product Description: CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY.",
      "code_info": "REF: 332079; Product Code: CE17TKFC; UDI-DI (Primary): 04046955899456; UDI-DI (Unit of Use): 04046955899463; Lot Numbers: 0062010541, 0062010542, 0062010543, 0062010545, 0062010546, 0062010547, 0062010548, 0062010549, 0062010550, 0062010743, 0062013041, 0062013042, 0062013043, 0062013044, 0062013045, 0062013046, 0062013047, 0062013049, 0062015114, 0062015113, 0062015112, 0062015110. Expiration Date: 07/31/2026.",
      "firm_fei_number": "3013764800",
      "recalling_firm": "B BRAUN MEDICAL INC",
      "address_1": "861 Marcon Blvd",
      "city": "Allentown",
      "state": "PA",
      "postal_code": "18109-9577",
      "additional_info_contact": "Allison Longenhagen\n001-484-2408373",
      "reason_for_recall": "Potential for the lid of the catheter connector to be in the incorrect position.",
      "root_cause_description": "Process control",
      "action": "B Braun notified consignees on about 09/18/2025 via USPS certified mailed URGENT MEDICAL DEVICE CORRECTION NOTIFICATION. Consignees were instructed to, where possible, have a second kit or additional catheter connector available at the point of use and upon opening the kit, verify the correct catheter connector is present. If the affected component is detected, discard and do not use. Consignees were also instructed to review the Medical Device Correction Notification and ensure all users in your organization and other concerned persons are informed, if affected units have been further distributed, notify customers, post the notification where affected units are stored, and complete and return the \"Urgent Medical Device Correction Acknowledgement Form.\"  Additionally, if consignees have identified affected units in inventory, they may order one case (50 pieces) of affected sterilized single use catheter connectors to have on hand.",
      "product_quantity": "48,110 units",
      "distribution_pattern": "Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.",
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        "device_name": "Epidural Anesthesia Kit",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5120",
        "device_class": "2"
      }
    }
  ]
}