FDA-Device2026-02-04Class IMISBRANDING
SunMed Broselow Tape recalled for incorrect pediatric medication dosing
FALSE CLAIMSNationwide distribution
Stop using affected Broselow Tape units
The Broselow Tape, a tool used in pediatric emergency care to determine medication doses based on a child's length and weight, contains dosing errors for three medications: Vecuronium, Flumazenil, and Ketamine. These errors could lead to incorrect doses being given in emergency situations. The affected units have specific lot numbers and are distributed in the US, Canada, Hong Kong, and Singapore.
- Check if your facility has Broselow Tape with lot numbers 0004317699, 0004333171, or 0004333593
- Stop using affected units immediately
- Contact SunMed Holdings or your supplier for instructions on replacement or correction
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
89
Manufactured in
2710 Northridge Dr Nw Ste A, N/A, Grand Rapids, MI, United States
Products
Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS 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-1117-2026Don't want to check this manually?
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