{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "196573",
      "product_res_number": "Z-0278-2023",
      "event_date_initiated": "2022-10-10",
      "event_date_posted": "2022-11-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-01-17",
      "res_event_number": "91037",
      "product_code": "OGE",
      "product_description": "PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4\" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each tray contains 5ml Ampule 1% Lidocaine HCl, 10ml Ampule 0.9% Sodium Chloride, and 5ml Ampule 1.5% Lidocaine HCl with Epinephrine 1:200,000.",
      "code_info": "Lot 0001359, Exp. date 2024-04-01, UDI (01) 00858965006007(17)240401(10)0001859..",
      "firm_fei_number": "3004076349",
      "recalling_firm": "Pajunk Medical Systems, L.P.",
      "address_1": "4575 Marconi Drive",
      "city": "Alpharetta",
      "state": "GA",
      "postal_code": "30005",
      "additional_info_contact": "Angela Meyer\n770-493-6832",
      "reason_for_recall": "The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,.",
      "root_cause_description": "Process control",
      "action": "The recalling firm issued recall letters dated 10/10/2022 via email and overnight mail on 10/10/2022.  The letter identified the product, the reason for recall and requested return of the affected lot as soon as possible.  A return label was enclosed for return of product.  A Customer Acknowledgment form was enclosed for return via email to report the quantity of product being returned.  The form also asked the consignee if they remembered any used trays containing the 2ml ampule 0.75% Spinal Marcaine instead of the tray containing a 10ml ampule 0.9% Sodium Chloride.  If the answer was yes, the consignee was to report whether the Marcaine was used and were there any adverse outcomes.",
      "product_quantity": "280 trays",
      "distribution_pattern": "US Nationwide distribution in the states of CA, NC, TN, PA, and TX.",
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        "device_name": "Epidural Anesthesia Kit",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5120",
        "device_class": "2"
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