{
  "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": 4
    }
  },
  "results": [
    {
      "cfres_id": "217896",
      "product_res_number": "Z-1114-2026",
      "event_date_initiated": "2025-12-15",
      "event_date_posted": "2026-01-28",
      "recall_status": "Open, Classified",
      "res_event_number": "98208",
      "product_code": "OKI",
      "product_description": "Brand Name: Broselow\nProduct Name: Broselow Pediatric Emergency Rainbow Tape\nModel/Catalog Number: 7700REA\nSoftware Version: Not Applicable\nProduct Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.\nComponent: No",
      "code_info": "Lot Code: Lot/Serial Number(s)\n0004306540\n0004316209\n0004328895\n0004329080\n0004330876\n0004331254\n0004332994\n0004338228\n0004338229\n0004338230\n0004339717\n\nUDI-DI\nEach-10889483588970\nCase-30889483588974",
      "firm_fei_number": "1314417",
      "recalling_firm": "SunMed Holdings, LLC",
      "address_1": "2710 Northridge Dr Nw Ste A 2710 Northridge Dr Nw",
      "address_2": "Ste A",
      "city": "Grand Rapids",
      "state": "MI",
      "postal_code": "49544-9112",
      "additional_info_contact": "Jessica Hoke\n1-616-2598400",
      "reason_for_recall": "Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.",
      "root_cause_description": "Device Design",
      "action": "AirLife issued an URGENT:  MEDICAL DEVICE RECALL NOTICE to its consignees on 12/15/2025 via email and US mail.  The notice explained the issue, potential risk to the patient, and requested the following:    \n\"Customer immediate actions:  \nPlease take the following actions immediately:  \n1. Stop using the affected tapes  \no Immediately discontinue use of all AirLife Broselow Rainbow Tapes identified as 2025 Edition, 36-23446 Rev 3 Print Version.  \n2. Identify and segregate affected product  \no Examine your inventory and clinical areas for affected Broselow Rainbow Tapes (see Image B for identifying characteristics).  \no Remove all affected tapes from clinical service.  \no Segregate or quarantine the affected tapes to prevent further use.  \n3. Follow disposition instructions  \no Follow the instructions provided in the accompanying communication regarding \ndiscarding/destruction of the affected tapes.  \no Do not redistribute or place any affected tapes back into service.  \n4. Notify your internal users  \no Ensure that all clinicians and healthcare professionals within your organization \nwho may use the Broselow Rainbow Tape are informed of this recall/field removal and understand that the affected Rev 3 tapes must not be used.  \n5. Notify downstream customers (if applicable)  \no If you have further distributed the affected tapes, please identify your customers/consignees and notify them of this recall/field removal promptly.  \no Your notification may be enhanced by including a copy of this letter.  \no If you have impacted product on hand, do not ship it; instead, hold it for discarding/destruction as instructed.  \n6. Complete and return the Response Form \no Please complete and return the attached Response Form via e-mail to \nproductquality@myairlife.com as soon as possible. Please complete and return \nAttachment B if you have affected product for discarding/destruction. This allows us to document your receipt of this recall notice and the status of affected product at",
      "product_quantity": "95300",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.",
      "openfda": {
        "registration_number": [
          "1061124",
          "1314417",
          "3005798963",
          "3009888344",
          "3004111573",
          "1643817",
          "3007329020",
          "3043668807",
          "8030673",
          "3006108746",
          "1423537",
          "3003770530",
          "9616088"
        ],
        "fei_number": [
          "1314417",
          "3005798963",
          "3009888344",
          "3004111573",
          "1000512168",
          "3001236905",
          "1643817",
          "3043668807",
          "3002902735",
          "3007329020",
          "3006108746",
          "3004213967",
          "3003770530"
        ],
        "device_name": "Emergency Response Safety Kit",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4040",
        "device_class": "2"
      }
    }
  ]
}