FDA-Device2026-02-04Class IMISBRANDING
SunMed Broselow Pediatric Emergency Tape recalled for medication dosing errors
FALSE CLAIMSNationwide distribution
Stop using SunMed Broselow emergency tape
The Broselow Tape, a tool used in pediatric emergencies to calculate medication doses based on a child's length and weight, contains incorrect dosing information for three medications: Vecuronium, Flumazenil, and Ketamine. These errors could lead to wrong doses being given during emergency care. The FDA has classified this as a Class I recall, the most serious category.
- Stop using the affected Broselow Tape immediately if you have one in your facility
- Check if your tape's lot number matches the list provided by the FDA
- Contact SunMed Holdings or your medical supplier for a replacement or corrected version
- Notify your clinical staff and emergency team about this recall
Hazard
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
Affected count
95300
Manufactured in
2710 Northridge Dr Nw Ste A, N/A, Grand Rapids, MI, United States
Products
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1114-2026Don't want to check this manually?
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