BEUDAMED
    FDA Recall Open, Classified

    Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.

    Recall: Z-1904-2025 · Initiated May 15, 2025

    Recall

    Recall Number
    Z-1904-2025
    Event Number
    96891
    Firm
    SunMed Holdings, LLC
    FEI Number
    1314417
    Product Code
    OKI
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 15, 2025
    Posted
    June 20, 2025
    Address
    2710 Northridge Dr Nw, Ste A, Grand Rapids, MI, 49544-9112

    Description

    Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.

    Reason

    The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.

    Action

    On May 15, 2025, the firm began notifying customers via Urgent Medical Device Recall letters. Customers were given detailed information about the incorrect information printed on the tape. Customers were instructed to identify and quarantine all affected product in inventory. Customers should destroy and dispose of all affected product. If product was further distributed, distributors should identify their customers/consignees and notify them of the recall. The firm will provide replacement products once customer confirms destruction of affected product.

    Distribution

    US distribution nationwide. International distribution to Canada.

    Quantity

    9900 eaches