BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No

    Recall: Z-1116-2026 · Initiated December 15, 2025

    Recall

    Recall Number
    Z-1116-2026
    Event Number
    98208
    Firm
    SunMed Holdings, LLC
    FEI Number
    1314417
    Product Code
    OKI
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    December 15, 2025
    Posted
    January 28, 2026
    Address
    2710 Northridge Dr Nw, Ste A, Grand Rapids, MI, 49544-9112

    Description

    Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No

    Reason

    Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

    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: "Customer immediate actions: Please take the following actions immediately: 1. Stop using the affected tapes o Immediately discontinue use of all AirLife Broselow Rainbow Tapes identified as 2025 Edition, 36-23446 Rev 3 Print Version. 2. Identify and segregate affected product o Examine your inventory and clinical areas for affected Broselow Rainbow Tapes (see Image B for identifying characteristics). o Remove all affected tapes from clinical service. o Segregate or quarantine the affected tapes to prevent further use. 3. Follow disposition instructions o Follow the instructions provided in the accompanying communication regarding discarding/destruction of the affected tapes. o Do not redistribute or place any affected tapes back into service. 4. Notify your internal users o Ensure that all clinicians and healthcare professionals within your organization who 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. 5. Notify downstream customers (if applicable) o If you have further distributed the affected tapes, please identify your customers/consignees and notify them of this recall/field removal promptly. o Your notification may be enhanced by including a copy of this letter. o If you have impacted product on hand, do not ship it; instead, hold it for discarding/destruction as instructed. 6. Complete and return the Response Form o Please complete and return the attached Response Form via e-mail to [email protected] as soon as possible. Please complete and return Attachment 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

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.

    Quantity

    384