{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "221992",
      "product_res_number": "Z-3106-2026",
      "event_date_initiated": "2026-07-23",
      "event_date_posted": "2026-09-09",
      "recall_status": "Open, Classified",
      "res_event_number": "99613",
      "product_code": "OGJ",
      "product_description": "Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules",
      "code_info": "UDI-DI: 10809160367414. Lot(Expiration Date):\n322200(4/1/2026), 324586(4/1/2026), 327335(4/1/2026), 329618(9/1/2026), 347199(11/1/2026), 337283(11/1/2026), 350354(11/30/2026), 375449(5/31/2027)",
      "firm_fei_number": "1030451",
      "recalling_firm": "Medical Action Industries, Inc. 306",
      "address_1": "25 Heywood Rd",
      "city": "Arden",
      "state": "NC",
      "postal_code": "28704-9302",
      "reason_for_recall": "Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On 7/23/2026, \"Urgent: Medical Device Recall\" notices were emailed to customers who were asked to do the following:\n\n1) Identify, Segregate, and Quarantine all impacted kits.\n2) Add warning labels to affected kits to ensure all users are aware of the actions to take prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If pre-printed labels are needed, please contact your sales representative.\n3) REMOVE AND DISCARD the Sodium Chloride, 0.9%, USP 10 mL Flush ampules prior to use.\n4) Customers (end-users): If you have received product from a distributor, please contact the distributor or your sales representative with any questions you may have.\n5) Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness.\n6) Complete and return the Recall Response Form via email to GM-OMRA_RECALLS@owens-minor.com\n\nReport any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com\n\nIf you have any questions, contact Regulatory Affairs Manager at email: GM-OMRA_RECALLS@owens-minor.com.",
      "product_quantity": "1,960",
      "distribution_pattern": "US distribution to states of: IA, VA, MO, KS, FL, OH and LS.",
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        "device_name": "Nerve Block Tray",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5140",
        "device_class": "2"
      }
    }
  ]
}