{
  "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": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "cfres_id": "221723",
      "product_res_number": "Z-3000-2026",
      "event_date_initiated": "2026-06-29",
      "event_date_posted": "2026-08-21",
      "recall_status": "Open, Classified",
      "res_event_number": "99514",
      "product_code": "OEZ",
      "product_description": "American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM",
      "code_info": "Lot Code: Lot Number: 42-8493811\nUDI: 191072232991\nExpiration Date: 7/15/2026",
      "firm_fei_number": "3008492337",
      "recalling_firm": "American Contract Systems Inc",
      "address_1": "85 Shaffer Park Dr",
      "city": "Tiffin",
      "state": "OH",
      "postal_code": "44883-9290",
      "additional_info_contact": "Marlene Jones\n+1-470-2804277",
      "reason_for_recall": "The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "An URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter dated 6/29/26 was sent to customers.\n\nACTIONS TO TAKE:\n\"Identify, segregate, and quarantine all impacted product. Other components within the convenience kits can still be used once kit is properly labeled with the warning label below.\n\"Add warning labels to affected ACS kits to ensure all users are aware of the actions below and identified in the enclosed Medline recall notice. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. Please contact your Sales Representative if pre-printed labels are needed. 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.\n\"Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have, or to request printed labels.\n\"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.\n\"Complete the attached Recall Response Form and return by July 17, 2026.\n\nReport any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com . Your assistance is appreciated and necessary to prevent any risk to patient or medical professional health as a result of not following these instructions.",
      "product_quantity": "30 units",
      "distribution_pattern": "US Nationwide distribution in the states of IA, OH.",
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        "device_name": "Cardiovascular Procedure Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      }
    }
  ]
}