FDA-Device2026-02-04Class IMISBRANDING
Broselow Domestic Complete ALS Organizer recalled for incorrect medication dosing
What this means
The Broselow Tape, a tool used in pediatric emergency care to determine correct 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 during emergency treatment.
- Stop using Broselow Domestic Complete ALS Organizer model 7730ALS immediately
- Check if your facility received lot numbers 0004312284, 0004314503, or 0004333110
- Contact SunMed Holdings or your device supplier for instructions on replacement or verification
- Review any recent uses of this tool to ensure correct doses were administered
The agency's original wording
Hazard
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Intended for
Children (under 18 years)
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
Affected count
384
Manufactured in
2710 Northridge Dr Nw Ste A, N/A, Grand Rapids, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1116-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.