{
  "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": "2026-08-22",
    "results": {
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  "results": [
    {
      "cfres_id": "208130",
      "product_res_number": "Z-2742-2024",
      "event_date_initiated": "2024-04-08",
      "event_date_posted": "2024-08-28",
      "recall_status": "Open, Classified",
      "res_event_number": "94581",
      "product_code": "OES",
      "product_description": "Medline procedural kits labeled as:  \n1) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; \n2) CIRCUMCISION TRAY, Pack Number CIT6715; \n3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095",
      "code_info": "1) MNS9865 , Lot Number 2021111050; \n2) CIT6715 , Lot Number 2023050590; \n3) CIT7095 , Lot Number 2023091990;",
      "firm_fei_number": "1417592",
      "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "additional_info_contact": "Karin Johnson\n886-359-1704",
      "reason_for_recall": "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request  the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.",
      "distribution_pattern": "Worldwide",
      "openfda": {
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        "device_name": "Cardiac Catheterization Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      }
    }
  ]
}